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Journal of Consulting and Clinical Psychology

2005, Vol. 73, No. 4, 634 646

Copyright 2005 by the American Psychological Association


0022-006X/05/$12.00 DOI: 10.1037/0022-006X.73.4.634

Couple-Focused Group Intervention for Women With Early Stage


Breast Cancer
Sharon L. Manne

Jamie S. Ostroff

Fox Chase Cancer Center

Memorial Sloan Kettering Cancer Center

Gary Winkel

Kevin Fox

City University of New York

Hospital of the University of Pennsylvania

Generosa Grana

Eric Miller

Cooper Hospital

Virtua Memorial Hospital

Stephanie Ross

Thomas Frazier

Evanston Healthcare

Bryn Mawr Hospital

This study examined the efficacy of a couple-focused group intervention on psychological adaptation of
women with early stage breast cancer and evaluated whether perceived partner unsupportive behavior or
patient functional impairment moderated intervention effects. Two hundred thirty-eight women were
randomly assigned to receive either 6 sessions of a couple-focused group intervention or usual care.
Intent-to-treat growth curve analyses indicated that participants assigned to the couples group reported
lower depressive symptoms. Women rating their partners as more unsupportive benefited more from the
intervention than did women with less unsupportive partners, and women with more physical impairment
benefited more from the intervention group than did women with less impairment. Subgroup analyses
comparing women attending the couple-focused group intervention with women not attending groups and
with usual care participants indicated that women attending sessions reported significantly less distress
than did women receiving usual care and women who dropped out of the intervention.
Keywords: psychological intervention, breast cancer, couples group

worries about future cancer recurrence, as well as deal with managing family responsibilities and social plans. Even after treatment
is completed, patients negotiate the transition back to normal
life. These experiences can take an emotional toll on some patients, both in the short- and long-term. Between 7% and 46% of
women with early stage breast cancer report clinically significant
levels of anxiety or depressive symptoms within the first 6 months
of diagnosis (Gallagher, Parle, & Cairns, 2002).
A number of psychological interventions have been developed
and evaluated to reduce distress among early stage breast cancer
patients. The majority of randomized clinical trials evaluating
psychosocial interventions for women diagnosed with early stage
breast cancer have examined the efficacy of patient-focused treatments (e.g., Antoni et al., 2001; Helgeson, Cohen, & Schulz,
2000). Although many of these approaches have proven effective,
they do not take advantage of the family context of cancer and a
key source of support for patients, namely the partner (Pistrang &
Barker, 1995). In the clinical trials incorporating partners in psychological interventions, there is considerable variation in the
manner that partners have been incorporated. Studies have used
couple-focused interventions (e.g., Christensen, 1983), individualfocused interventions delivered to both patient and partner at the
same time (e.g., Donnelly et al., 2000), and interventions targeting

The diagnosis and treatment of early stage breast cancer can be


stressful and upsetting. Patients deal with the emotional consequences of being diagnosed with a life-threatening illness, cope
with invasive medical treatments that can result in difficult side
effects, such as nausea, weight gain, and fatigue, and manage

Sharon L. Manne, Population Science Division, Fox Chase Cancer


Center, Philadelphia; Jamie S. Ostroff, Department of Psychiatry and
Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York;
Gary Winkel, Department of Psychology, The Graduate Center, City
University of New York; Kevin Fox, Department of Medicine, Hospital of
the University of Pennsylvania; Generosa Grana, Department of Medicine,
Cooper Hospital, Voorhees, New Jersey; Stephanie Ross, Evanston Healthcare, Evanston, Illinois; Eric Miller, Department of Surgery, Virtua Memorial Hospital, Mt. Holly, New Jersey; Thomas Frazier, Department of
Surgery, Bryn Mawr Hospital, Bryn Mawr, Pennsylvania.
This work was funded by National Cancer Institute Grant CA 77857.
We thank Marne Sherman, Joseph Zike, Jennifer Stillman, Jeanette Hosterman, Jean Schueller, and Mary Plummer for study management; the
oncologists who contributed patients to this study; and the couples who
participated.
Correspondence concerning this article should be addressed to Sharon
L. Manne, Fox Chase Cancer Center, 333 Cottman Avenue, P1100, Philadelphia, PA 19111. E-mail: sharon.manne@fccc.edu
634

COUPLE-FOCUSED INTERVENTION

only partners (e.g., Toseland, Blanchard, & McCallion, 1995).


Because the present study evaluates a couple-focused intervention,
we will review the relevant literature briefly.
As has been described by Baucom, Shoham, Mueser, Daiuto,
and Stickle (1998), couple-focused interventions can be categorized according to the target of intervention and the role of the
partner. One approach to couple-level intervention is to have the
partner present but not actively involved in the intervention. Although it has not been evaluated in the cancer context, this approach has been evaluated and found efficacious in other illness
populations (e.g., Keefe et al., 1996). A second approach to
couple-level intervention is to incorporate the partner as an assistant or coach. The partners role is to assist the patient in
learning coping skills. In the one study using this approach in the
cancer context, Nezu, Nezu, Felgoise, McClure, and Houts (2003)
examined the efficacy of problem-solving therapy among people
diagnosed with different types of cancers. Distressed participants
received either 10 sessions of individual problem-solving skills
therapy or 10 sessions of problem-solving skills therapy with a
significant other present to provide support. Results indicated that
participants in problem-solving skills therapy reported lower distress and better clinician ratings of functioning than did wait-list
controls. Partner-assisted interventions have also been compared
with individual-level interventions or other couple-level approaches in other illness populations, including arthritis. Findings
have not been consistent. For example, the majority of studies of
arthritis populations have suggested that partner-assisted interventions result in better patient outcomes, such as less distress, pain,
and disability (Martire et al., 2003). However, other studies found
either that partner-assisted coping skills intervention was superior
to patient education in which the partner was present for support
and education but not superior to individual-patient coping skills
intervention (Keefe et al., 1996) or that the participation of partners did not lead to improved patient outcomes (Riemsma, Taal, &
Rasker, 2003).
A second type of couple-level intervention is to target both
partners and to focus on the relationship. Session content can
contain communication, dealing with changes in the relationship,
and/or coping as a couple. There have been very few studies using
this approach in the cancer setting. Christensen (1983) conducted
a small randomized trial of a couple-focused, four-session communication intervention for women who underwent mastectomy
and their husbands. Compared with the no-treatment control
group, couples receiving the intervention reported higher sexual
satisfaction and lower emotional discomfort, and persons with
cancer reported significantly lower depressive symptoms. Although relatively preliminary, this study suggests that couplefocused interventions may be efficacious for patients.
For the present study, we developed a couple-focused intervention for women with early stage breast cancer and their partners.
Our intervention was guided by cognitivesocial processing theory
of how people adjust to traumatic events (e.g., Creamer, Burgess,
& Pattison, 1990). This theory suggests that successful processing
involves actively assimilating or accommodating the event into
ones worldview, which typically involves finding some meaning
in the event. Although some cognitive processing is done on an
individual level, the social network can aid or interfere with
effective processing (Clark, 1993). Talking with others may facilitate successful processing by allowing the expression of emotions,

635

by helping the person learn to tolerate aversive feelings, by provision of support and encouragement of effective coping, and by
direct assistance in finding meaning and benefit in the experience.
Conversely, not being able to talk about a difficult experience with
family and friends because one perceives ones family or friends as
unsupportive may place individuals at higher risk for adverse
psychological reactions. Barriers to sharing the cancer experience
with ones partner may be particularly problematic because of the
level of importance the partner has as a source of support (Pistrang
& Barker, 1992). Thus, our intervention promoted open communication and processing of the cancer experience in the marital
dyad.
When evaluating the efficacy of an intervention, it is important
to consider that interventions may not prove efficacious for all
patients, and thus it may be important to identify subgroups of
participants benefiting more than others. In the present study, we
evaluated two potential moderators: partner unsupportive responses and patient physical impairment. As described above,
cognitivesocial processing theory suggests that an unsupportive
social environment is detrimental to patients adaptation. Women
who have a particularly unsupportive partner are likely to benefit
more from an intervention facilitating improved communication
with and support from the partner. A second factor that may
moderate the efficacy of a couple-focused intervention is the level
of physical impairment experienced. Women coping with a higher
level of disease-related physical impairment may benefit more
from a communication and support-based intervention. Thus, we
proposed that participants with higher levels of physical disability
would benefit more from the couple-focused intervention than
would participants with lower disability levels.
The main goal of the present study was to evaluate the efficacy
of a couple-focused group (CG) intervention on the psychological
adaptation of women with breast cancer. The intervention was
designed to enhance support exchanges and coping skills. We
hypothesized that women assigned to the intervention group would
evidence less distress and greater well-being. Our second aim was
to determine whether our intervention would be more effective for
particular subgroups of women. To this end, we examined two
moderators: perceived partner unsupportive behaviors and patient
physical impairment at the preintervention assessment. We hypothesized that women with higher perceived partner unsupportive
behavior at the preintervention assessment would show greater
benefit from the intervention, which had a primary focus on
couples communication. We predicted that women with more
functional impairment would benefit more from the intervention.
To test the above hypotheses, we conducted a randomized clinical
trial comparing a CG intervention with a usual care (UC) control
condition. Women were followed with two assessments, 1 week
and 6 months after the group intervention.

Method
Participants
Participants were women with early stage breast cancer who had undergone breast cancer surgery within the last 6 months and were married or
cohabiting, and their significant others. This study took place at three
comprehensive cancer centers in two major cities and four community
hospitals in New Jersey and Pennsylvania. Criteria for study inclusion were
as follows: (a) participant had a primary diagnosis of ductal carcinoma in

636

MANNE ET AL.

situ or Stage 1, 2, or 3a breast cancer; (b) at recruitment, participant had an


Eastern Cooperative Oncology Group (ECOG) performance status of 0
(fully active, able to carry on all predisease performance without restriction) or 1 (restricted in physically strenuous activity but ambulatory and
able to carry out work of a light or sedentary nature); (c) participant had
undergone breast cancer surgery; (d) participant was married or living with
a significant other of either gender; (e) both partners were 18 years of age
or older; (f) both partners were able to give informed consent; (g) both
partners were English speaking.

Procedure
Eligible women were identified and approached by the research assistant
either after an outpatient visit or by telephone. The study design and
procedures were described in detail during this contact. Participants were
given a written informed consent and the study questionnaire to complete
and return by mail. All participants signed an informed consent approved
by an institutional review board. After informed consent and preintervention surveys were received, couples were randomly assigned to either the
CG condition or a UC control condition. Randomization was performed in
blocks of 14 to allow for the formation of couples groups. Assessment
time points were preintervention (baseline), 1 week postintervention, and 6
months postintervention. Participants in the UC condition were sent
follow-up surveys at the same point in time as CG participants within their
same block of 14 couples in order to equate for time since baseline in the
two conditions. Patients were paid $20 per set of questionnaires returned,
and patients assigned to the intervention condition were paid $15 for each
session attended to cover travel and parking expenses. Recruitment began
in April 2000 and ended in October 2003.
As shown in Figure 1, 710 couples were approached for study participation. Two hundred thirty-eight couples consented and completed the
baseline survey (33% acceptance). The most common reason for refusal
provided was that the group would take too much time. The majority
(46%) did not provide a reason. Comparisons were made between the 238
patient participants and the 472 refusers with regard to available data (i.e.,
age, ethnicity, cancer stage, performance status). Results indicated that
study participants were significantly younger (Mparticipants 49.4, SD
10.6; Mrefusers 52.1, SD 10.8), t(708) 3.1, p .01; and had higher
performance status ratings on the ECOG scale (91% of participants had a
score of 0 [no symptoms]; 77% of refusers had a score of 0), 2(708, N
710) 17.3, p .001. There were no differences between participants and
refusers in terms of ethnicity (Caucasian vs. non-Caucasian) or cancer
stage.

Figure 1. Study schema.


communicate support needs. Session 6 focused on anticipating the posttreatment transition phase, particularly in terms of changes in the couples
relationship before, during, and after cancer. The manual is available from
the studys authors (Sharon L. Manne or Jamie S. Ostroff).
UC condition. Couples assigned to UC received standard psychosocial
care. At all study sites, usual care was the same: Social work consultations
were routinely provided for all women. If indicated, a referral to a psychiatrist or psychologist was provided by physicians.

Measures
Intervention Conditions
CG condition. The intervention consisted of six weekly 90-min sessions. Session content focused on enhancing support exchanges and coping
skills. The goals of Session 1 were to orient participants to the group,
establish rapport with the group leaders, foster connections among group
participants, and facilitate expression of feelings in the group. Exercises
were adapted from multiple family group techniques developed by Ostroff,
Steinglass, Ross, Ronis-Tobin, and Singh (2004). Session 2 focused on
couple-level stress management (e.g., recognizing stress in one another,
respecting differences in coping styles) and relaxation techniques (e.g.,
listening to a relaxation tape together). Session 3 covered couple-focused
coping (e.g., problem solving as a team) as well as sexuality and breast
cancer (e.g., sensate focus as homework). Session 4 focused on basic
communication concepts and skills (e.g., constructive and destructive communication). Basic communication skills techniques were adapted from the
Prevention and Relationship Enhancement Program (Markman & Floyd,
1980) and from Gottman and colleagues (Gottman, Notarius, Gonso, &
Markman, 1976) communication intervention and were adapted to the
context of dealing with cancer. Session 5 focused on constructive ways to

General distress. Participants completed the Mental Health Inventory18 (MHI18; Ware, Manning, Duan, Wells, & Newhouse, 1984).
This scale consisted of three distress subscales, Anxiety (4 items), Depression (4 items), and Loss of Behavioral and Emotional Control (BEC) (4
items), and a Well-Being subscale (6 items). Participants used a 5- or
6-point Likert scale to rate their feelings over the past month. Internal
consistency coefficients for the three time points were excellent (Anxiety,
.85, .85, .90; Depression, .88, .85, .91; Loss of Behavioral and
Emotional Control, .81, .80, .90; Well-Being, .87, .86, .91).
Cancer-specific distress. Participants completed the Impact of Event
Scale (IES; Horowitz, Wilner, & Alvarez, 1979), which is a 15-item
self-report measure focusing on intrusive and avoidant ideation associated
with a stressorin this case, breast cancer and its treatment. The IES has
been used in studies of women with cancer (e.g., Baider et al., 2003). Using
a 4-point Likert scale, participants rated how true each statement had been
for them during the past week. Cronbachs alphas were .89, .89, and .91,
at Times 1, 2, and 3, respectively.
Partner unsupportive behaviors (Manne & Schnoll, 2001). The Partner
Unsupportive Behaviors Scale consisted of 17 items assessing critical

COUPLE-FOCUSED INTERVENTION
responses, such as criticism of the womans ways of handling the cancer
and appearing uncomfortable when she talked about her cancer. Items were
rated on a 4-point response scale. Internal consistency was .88, .89, and .91
at Times 1, 2, and 3, respectively.
Physical impairment. Physical impairment was assessed with the
Functional Status subscale of the Cancer Rehabilitation Evaluation System
(CARES; Schag & Heinrich, 1988). Twenty-six items assessed functional
disability caused by the cancer and its treatment. Participants rated difficulty during the past month from 0 (not at all) to 4 (very much). Higher
scores indicated greater impairment. Internal consistency was .93 at Times
1, 2, and 3.
Treatment expectancy. A modified Expectancy Rating Form (Borkovec & Nau, 1972) was administered to group participants at the end of
Session 1. Participants used 4-point Likert scales to rate how logical the
treatment seemed, whether they would recommend it to others, and expectations for the treatments success (e.g., 1 not at all logical/successful,
4 extremely logical/successful). The coefficient alpha for this measure
was .80.
Treatment evaluation. A 20-item expanded version of Borkovec and
Naus (1972) scale was administered after the last session. Using 5-point
Likert scales, participants rated whether they learned anything new;
whether the sessions improved the marital relationship; their satisfaction
with the group; how helpful the therapist was; whether the participant used
any of the skills or believed she would use the skills in the future; the
helpfulness of each session; whether the participant would recommend the
sessions to another patient; the ease of attending sessions; the convenience
of the sessions; whether the topics covered were important; and whether
the materials were clear and easy to understand, tuned into her needs, and
helpful (1 not at all, 5 a great deal). Items were summed. The
coefficient alpha for this measure was .94.
Psychosocial care use. Participants completed a survey assessing any
psychosocial care (e.g., support group, formal psychological contacts)
obtained at each assessment time point.
Medical variables. Data regarding disease stage (1 to 3a), treatment
status, and ECOG symptom ratings were obtained from the medical chart
pretreatment and at the two follow-up time points. ECOG ratings were
made by the attending physician.

Group Leaders
Each group was co-led by a therapist team. Twenty therapists provided
the intervention. Therapists underwent 6 hours of training in the manualbased couples group protocol. To facilitate treatment fidelity, we structured the manual with suggested text for leaders and co-leaders and
in-session handouts for participants. Ongoing supervision was provided.
Sessions were audiotaped, and treatment fidelity was rated.

Results
Sample
Figure 1 illustrates the study flow. Two hundred thirty-eight
women consented to the study and completed a preintervention
survey. Of these 238 participants, 118 were assigned to UC and
120 were assigned to the CG condition. Among the 120 couples
assigned to the CG condition, 42 couples did not attend any group
sessions. Participants who did not attend group sessions were
offered the opportunity to complete follow-up surveys.
Survey attrition. Survey completion is shown in Figure 1. Of
the 238 participants who completed Time 1 surveys, 187 completed postintervention surveys (79%), and 163 completed
6-month follow-up surveys (68%). As can be seen in Figure 1,
survey completion rate was significantly higher among CG partic-

637

ipants. Attrition analyses comparing participants who completed


all surveys with participants who dropped after completing Time 1
indicated that survey completers were older, t(208) 2.7 years,
p .05 (Mcompleters 51.1 years, Mdropped 46.7 years), and
married longer, t(208) 2.0 years, p .05 (Mcompleters 23.9
years, Mdropped 19.4 years). Participants who dropped after Time
2 did not differ significantly from participants who completed all
surveys on Time 1 variables.
Treatment expectancy and evaluation. Participants expectancy ratings were very high (Item M 3.8 on a 4-point scale).
Treatment evaluation ratings were also high (Item M 4.0 on a
5-point scale). Individual average item ratings ranged from 3.6
(Have you used any of the skills that you have learned in the
group?) to 4.8 (Would you recommend this treatment to other
women with breast cancer and their partners?).
Preintervention differences and distress characteristics. Table
1 contains summary data for the participants by study condition
regarding demographic and medical characteristics. Multivariate
analysis of covariance and chi-square tests, in which hospital site
served as a covariate, revealed no differences between the two
conditions regarding demographic or medical variables. Overall,
an examination of hospital site as a covariate did not reveal that
this variable was a significant covariate. Thus, data from hospital
sites were combined in all analyses.
Table 2 contains the preintervention means and standard deviations for the distress measures. The MHI18 does not have an
established clinical cutoff score. Therefore, womens scores on the
MHI18 were compared with normative data provided by the
authors of this scale (Stewart et al., 1992). The mean of the present
sample was significantly higher than the normative mean,
t(3248) 5.7, p .05 (M 23.0, SD 15.2). If a standard
deviation of 1.5 above the group mean is used to determine
clinically significant levels of distress (Deragotis & Spencer,
1982), 9.6% of participants reported elevated anxiety, 9.6% of
participants reported elevated depression, and 7% of participants
reported elevated levels on the Loss of Behavioral and Emotional
Control subscale. In terms of IES scores, thresholds have been
identified for low (8.5), medium (9 19), and high (19) stress
responses (Horowitz, 1982). Sixty-two percent of the women
(62.4%) scored above 19 on the IES, indicating a high stress
response (Horowitz, 1982). The mean in the present sample was
significantly higher than the mean for the general population,
t(693) 7.37, p .05 (M 14.3, SD 17.0) (Briere & Elliott,
1998), and higher than a sample of breast cancer survivors,
t(250) 3.6, p .04 (M 16.4, SD 18.0) (Cordova, Cunningham, Carlson, & Andrykowski, 2001).

Treatment Fidelity
A random subset of 44% of sessions was rated for treatment
fidelity. The fidelity checklist was created by Sharon L. Manne
from the Couples Group Intervention manual. Fidelity criteria
consisted of topics covered in each session, whether in-session
exercises were conducted, and whether home assignments were
given. Raters coded whether each topic was addressed in the
session, whether exercises were conducted, and whether home
assignments were given. A fidelity score consisted of the percentage of topics, exercises, and home assignments completed in each
session, divided by the total number of possible fidelity criteria.

MANNE ET AL.

638

Table 1
Preintervention Demographic and Disease Information for Participants by Intervention Group
Variable
N
Age (years)
Race
White
Black
Asian
Hispanic
Years of education
college
college
Median family income
Relationship length (years)
Baseline ECOG ratings
0
1
Stage of disease
0
1
2
3a
Type of surgery
Mastectomy
Breast-cons surgery
Current treatment
None
Chemotherapy
Radiation
Psychosocial care (yes)

UC

CG full sample

CG attenders

CG attrition

118
49.76 (10.5)

120
49.25 (10.4)

78
49.68 (11.2)

42
48.5 (8.8)

107 (90.7)
4 (3.4)
4 (3.4)
3 (2.5)

106 (88.3)
7 (5.8)
2 (1.7)
5 (4.1)

67 (85.9)
4 (5.1)
2 (2.6)
4 (5.1)

39 (92.8)
3 (7.2)
0 (0)
0 (0)

39 (33.1)
79 (66.9)
$90,000
23.29 (12.56)

41 (34.2)
79 (65.8)
$85,000
21 (14.1)

26 (33.3)
52 (66.6)
$89,000
21.16 (14.1)

15 (35.7)
27 (64.3)
$85,000
20.7 (14.1)

114 (96.6)
4 (3.4)

101 (85.6)
17 (14.4)

73 (93.5)
5 (6.4)

42 (100)
0 (0)

14 (11.8)
38 (32.2)
63 (53.4)
3 (2.5)

8 (6.7)
47 (39.2)
61 (50.8)
4 (3.3)

5 (6.4)
29 (37.1)
41 (52.6)
3 (3.8)

3 (7.1)
18 (42.9)
20 (77.6)
1 (2.4)

27 (22.8)
91 (77.1)

31 (25.8)
89 (74.1)

23 (29.48)
55 (70.5)

8 (19.0)
34 (81.0)

25 (21.22)
68 (57.6)
12 (10.2)
65 (55.1)

24 (20)
74 (61.7)
15 (12.5)
71 (59.2)

18 (23.0)
45 (5.8)
10 (12.8)
47 (60.3)

6 (14.2)
29 (69.0)
5 (11.9)
24 (57.1)

Note. Numbers in parentheses are percentages for categorical variables and standard deviations for continuous variables (age, relationship length). Sample
sizes are preintervention figures. UC usual care control condition; CG couples group intervention condition; ECOG Eastern Cooperative Oncology
Group; Breast-cons surgery breast-conserving surgery.

Raters were three study assistants. Training consisted of a review


of the manual and fidelity criteria, followed by practice rating with
the project manager by using a set of 10 sessions previously rated
by the project manager. Once raters achieved an 80% interrater
reliability with the project manager, they were allowed to code
tapes. To guard against interrater drift, 12 tapes were coded by the
project manager and the fidelity coding team. Average interrater
agreement was 95%. Mean fidelity ranged from 97% (Session 1)
to 100% (Session 5). The mean fidelity was 98%.

Statistical Plan
The longitudinal data from this study were analyzed by using a
growth curve models approach (Moskowitz & Hershberger, 2002;
Singer & Willett, 2003). Growth curve analyses are designed to
understand group and individual rates of change in outcome variables over time and require a minimum of three assessments.
Growth curve analyses involve a mixed linear model approach,
which is also referred to as a random effects or hierarchic linear
model (Bryk & Raudenbush, 2002; Singer & Willett, 2003).
The first analysis focused on intent to treat (ITT), which included all participants who signed an informed consent and agreed
to be randomized. We also conducted subgroup analyses comparing participants who were assigned to the CG condition but did not
attend any intervention sessions (N 42; labeled CG attrition
[CG-A]), participants who were assigned to the CG condition and
attended at least one session (N 78), and the UC group (N

118). This analysis examined whether outcomes differed for


women who did not receive any couples group intervention compared with women who attended group sessions and with the UC
group.
In both the ITT and subgroup analyses, a three-step procedure
was used. First, for each outcome, time was considered the only
explanatory variable to determine whether each outcome changed
over time. In this and all subsequent analyses, the time variable
was nested within intervention group and both were treated as a
random effect. This analysis tested for individual differences in
preintervention levels of the outcome, rates of change over time,
and finally whether preintervention differences could account for
individual differences in rates of change over time. In both the ITT
and subgroup analyses, the results from this step were exactly the
same because the only explanatory variable involved in the model
was time.
In the second step, demographic, medical, site, treatment, and
psychological covariates were examined. Demographic covariates
included age, education, and the number of years living with the
partner. Medical covariates included baseline ECOG status and
stage of cancer (dichotomized into Stage 0 vs. Stages 1, 2, and 3a).
Covariates were selected because they have been associated with
psychological adaptation to cancer (e.g., younger age, less education, higher disease stage, greater number of years married) (e.g.,
Baider et al., 2003; McCaul et al., 1999). Hospital site was entered
as a main effect as were therapist and session attendance (as a

COUPLE-FOCUSED INTERVENTION

639

Table 2
Means and Standard Deviations for Study Outcomes by Intervention Group
UC
Variable
MHI depression
Preintervention
Postintervention
6-month follow-up
MHI anxiety
Preintervention
Postintervention
6-month follow-up
MHI loss of behavioral and emotional control
Preintervention
Postintervention
6-month follow-up
IES total
Preintervention
Postintervention
6-month follow-up
MHI well-being
Preintervention
Postintervention
6-month follow-up

CG full sample

CG attenders

CG attrition

SD

SD

SD

SD

9.10
8.90
8.95

2.52
2.77
3.90

9.37
8.60
8.14

2.85
2.69
2.98

9.10
8.10
7.70

2.53
2.25
2.33

9.88
10.07
9.72

3.23
3.43
4.34

10.08
9.81
10.28

3.57
3.56
4.87

10.34
9.86
9.21

3.50
3.40
3.17

10.08
9.54
8.77

3.57
3.26
2.99

10.83
10.91
10.78

3.35
3.67
3.41

8.88
8.04
8.52

2.82
2.82
4.26

8.82
8.06
7.73

3.02
2.84
2.93

8.88
7.55
7.23

2.82
2.38
2.41

8.73
9.72
9.50

3.38
3.55
3.91

23.30
20.89
17.57

15.02
14.74
15.53

24.18
19.26
16.77

14.82
13.71
13.88

23.30
19.35
15.72

15.01
13.86
13.89

25.82
19.00
20.61

14.47
13.54
13.54

24.54
25.63
25.58

4.94
4.90
6.18

24.12
25.98
26.52

5.12
4.96
5.20

24.54
26.65
27.28

4.94
4.65
4.53

23.36
23.82
23.83

5.42
5.42
6.55

Note. UC usual care control condition; CG couples group intervention condition; MHI Mental Health Inventory18; IES Impact of Events
Scale.

substitute for treatment group). In all instances, these covariates


were tested for any interactions with intervention group. The
proposed moderators, preintervention physical impairment and
perceived partner unsupportive behavior, were included to control
for their effects preintervention and, more importantly, to evaluate
their proposed moderating role in intervention effects. At this step,
the dichotomous variable for intervention group (trichotomous for
the secondary analyses) was included to determine whether there
was an intervention group main effect after controlling for sociodemographic and medical variables as well as potential moderators. In the third step, moderator effects were examined by crossing the intervention group main effect with time and the proposed
mean-centered moderators. All multiple mean comparisons were
Tukey adjusted.

ITT Analyses
We examined preintervention differences on all outcomes reported below, and there were no significant differences.
Depressive symptoms. Results are shown in the first panel of
Table 3. The first step, which was a model with time as the only
explanatory variable, showed a significant decline in depressive
symptoms over time, t(344) 3.23, p .0014, as well as
significant individual differences among patients both in preintervention depressive symptoms (z 7.03, p .0001) and in the
rates at which depressive symptoms changed over the study course
(z 2.82, p .0024). The covariation between preintervention
levels of depressive symptoms and rates of change in depressive
symptoms was not significant, indicating that individual differences in rates of change were not due to individual differences in
preintervention depressive symptoms. The second step of the analysis yielded a significant intervention group effect in favor of CG,

F(1, 226) 4.37, p .0376 (adjusted M 9.43), compared with


UC (adjusted M 8.82). In addition, more depressive symptoms
were reported by younger patients, patients with more physical
impairment, and those reporting more partner unsupportive behavior (see Table 3). In this analysis, as well as analyses of the other
outcomes, hospital site, therapist conducting the intervention, session attendance (dose), ECOG status, and cancer stage were not
significant predictors. In Step 3, interaction terms were entered
into the analysis. The Time Intervention Group interaction was
not significant. Analyses of partner unsupportive behavior moderator effects indicated a marginally significant Time Intervention
Group Partner Unsupportive Behavior interaction, F(1, 327)
2.87, p .0910. There were no significant moderator effects
involving physical impairment.
As a result of the significant interaction involving time, the final
model accounted for 8.24% of the variability among the women in
the rates at which depressive symptoms declined over time. However, because the rate parameter was still significant (z 2.55, p
.0054), other variables might account for the individual differences
in the rates at which depressive symptoms changed over time.
Anxiety. Results are shown in the second panel of Table 3. The
first step indicated a significant decline in anxiety over time,
t(344) 2.21, p .0280, and significant differences among
participants both in preintervention anxiety (z 8.02, p .0001)
and in the rates at which anxiety changed over time (z 2.38, p
.0085). The covariation between individual differences in preintervention anxiety and individual differences in the rates of change
was not significant, indicating that individual preintervention anxiety was not predictive of individual rate of change in anxiety. The
second and third steps indicated that the main effects and interactions involving intervention group were not significant (thus, Step

MANNE ET AL.

640

Table 3
Intent-to-Treat Results for Growth Curve Model Predicting Psychological Outcomes
Covariance parameter estimates
Effect

Parameter
estimate

Confidence interval

Tests of fixed effects


p

Parameter
estimate

Confidence interval

df

0.39

0.63, 0.15

344

3.23

.0014

0.44
0.07
0.05
0.12
0.59

0.68, 0.20
0.09, 0.04
0.03, 0.08
0.07, 0.16
1.15, 0.03

330
226
226
226
226

3.57
5.17
4.85
5.40
2.09

.0004
.0001
.0001
.0001
.0376

0.46
0.07
0.05
0.11
0.54
0.02
0.04
0.07
0.05

0.79, 0.014
0.09, 0.04
0.03, 0.07
0.04, 0.18
1.16, 0.09
0.11, 0.07
0.08, 0.001
0.56, 0.41
0.11, 0.008

327
225
225
225
225
225
327
327
327

2.78
5.21
4.60
3.08
1.70
0.49
2.02
0.31
1.70

.0058
.0001
.0001
.0023
.0912
.6219
.0444
.7605
.0910

0.28

0.52, 0.03

344

2.21

.280

0.27
0.06
0.05
0.15
0.53

0.52, 0.02
0.10, 0.03
0.03, 0.07
0.10, 0.19
1.23, 0.19

330
226
226
226
226

2.16
3.66
4.19
6.45
1.45

.0311
.0003
.0001
.0001
.1491

Dependent variable: MHI depressive symptoms


Step 1
Intercept
Intercept slope covariance
Slope
Step 1: Time
Step 2
Time
Age
CARES
Unsupp. beh.
Group
Step 3
Time
Age
CARES
Unsupp. beh.
Group
Group Unsupp. beh.
Time Unsupp. beh.
Time Group
Time Group Unsupp. beh.

5.8797
0.5494
1.0907

4.53, 7.94
1.43, 0.33
0.60, 2.54

7.03
1.22
2.82

.0001
.2230
.0024

Dependent variable: MHI anxiety


Step 1
Intercept
Intercept slope covariance
Slope
Step 1: Time
Step 2
Time
Age
CARES
Unsupp. beh.
Group

9.4865
0.5596
0.9618

7.54, 12.31
1.60, 0.48
0.49, 2.71

8.02
1.05
2.38

.0001
.2939
.0085

Dependent variable: MHI loss of behavioral and emotional control


Step 1
Intercept
Intercept slope covariance
Slope
Step 1: Time
Step 2
Time
Age
CARES
Unsupp. beh.
Group
Step 3
Time
Age
CARES
Unsupp. beh.
Group
Group Unsupp. beh.
Time Unsupp. beh.
Time Group
Time Group Unsupp. beh.

6.0708
0.6896
1.2388

4.55, 8.50
1.77, 0.39
0.64, 3.35

6.31
1.25
2.47

.0001
.2104
.0068

0.38

0.64, 0.12

344

2.83

.0049

0.42
0.05
0.05
0.12
0.50

0.69, 0.16
0.08, 0.02
0.02, 0.07
0.08, 0.16
1.10, 0.11

330
226
226
226
226

3.14
3.76
3.53
6.04
1.61

.0018
.0002
.0005
.0001
.1090

0.47
0.05
0.05
0.17
0.41
0.05
0.08
0.14
0.09

0.80, 0.015
0.08, 0.02
0.02, 0.07
0.10, 0.23
1.10, 0.27
0.04, 0.14
0.13, 0.04
0.66, 0.38
0.15, 0.03

327
225
225
225
225
225
327
327
327

2.88
3.65
3.50
5.24
1.18
0.98
3.68
0.52
2.75

.0042
.0003
.0006
.0001
.2375
.3272
.0003
.6063
.0063

COUPLE-FOCUSED INTERVENTION

641

Table 3 (continued )
Covariance parameter estimates
Effect

Parameter
estimate

Confidence interval

Tests of fixed effects


p

Parameter
estimate

Confidence interval

df

3.33

4.38, 2.28

348

6.24

.0001

3.50
0.29
1.22
0.20
0.28
1.98

4.64, 2.35
0.09, 0.49
0.40, 2.03
0.07, 0.32
0.06, 0.49
5.08, 1.11

313
209
209
209
209
209

6.01
2.83
2.95
3.05
2.57
1.26

.0001
.0051
.0036
.0025
.0108
.2080

3.53
0.52
0.28
1.20
0.08
0.24
2.02
0.21

4.67, 2.38
0.78, 0.26
0.08, 0.48
0.38, 2.02
0.09, 0.25
0.02, 0.46
5.10, 1.06
0.44, 0.02

313
208
208
208
208
208
208
208

6.07
3.96
2.76
2.89
0.96
2.19
1.29
1.76

.0001
.0001
.0063
.0042
.3386
.0296
.1977
.0793

1.01

344

3.38

.0008

0.68
0.09
0.07
0.20
0.26

0.30, 1.06
0.05, 0.14
0.11, 0.03
0.27, 0.13
0.78, 1.31

330
226
226
226
226

3.54
4.25
3.71
5.72
0.50

.0005
.0001
.0003
.0001
.6180

0.98
0.09
0.09
0.23
0.09
0.06
0.03
0.06
0.67
0.11

0.51, 1.45
0.05, 0.14
0.13, 0.05
0.32, 0.14
1.22, 1.04
0.20, 0.08
0.003, 0.06
0.01, 0.13
0.05, 1.40
0.03, 0.19

326
225
225
225
225
225
326
326
326
326

4.12
4.27
4.37
4.92
0.16
0.88
2.24
1.58
1.82
2.62

.0001
.0001
.0001
.0001
.8706
.3807
.0261
.1140
.0701
.0093

Dependent variable: IES


Step 1
Intercept
Intercept slope covariance
Slope
Step 1: Time
Step 2
Time
Years married
Education
CARES
Unsupp. beh.
Group
Step 3
Time
Age
Years married
Education
CARES
Unsupp beh.
Group
Group CARES

161.08
21.7098
20.0119

127.58, 209.83
40.10, 3.31
11.32, 44.58

7.91
2.31
2.94

.0001
.0207
.0016

Dependent variable: MHI positive well-being


Step 1
Intercept
Intercept slope covariance
Slope
Step 1: Time
Step 2
Time
Age
CARES
Unsupp. beh.
Group
Step 3
Time
Age
CARES
Unsupp. beh.
Group
Group Unsupp. beh.
Time CARES
Time Unsupp. beh.
Time Group
Time Group Unsupp. beh.

18.9820
1.4149
2.6232

15.05, 24.69
3.59, 0.76
6.00, 9.24

7.96
1.28
3.11

.0001
.2021
.0009
0.64

0.27,

Note. MHI Mental Health Inventory18; CARES physical impairment as assessed by the Functional Status subscale of the Cancer Rehabilitation
Evaluation System; Unsupp. beh. partner unsupportive behavior; IES Impact of Event Scale.

3 is not shown in Table 3). In terms of sociodemographic and


medical variables, greater anxiety was reported by younger participants, participants with greater physical impairment, and those
reporting more partner unsupportive behavior.
Loss of BEC. Results are shown in the third panel of Table 3.
The first step, which was a model with time as the only predictor,
indicated a significant decline in BEC over time, t(344) 2.83,
p .0049, as well as significant individual differences in preintervention levels of this outcome (z 6.31, p .0001) and in the

rates at which BEC declined over time (z 2.47, p .0068).


Covariation between preintervention individual differences and the
rates at which participants changed over time was not significant,
indicating that individual differences in preintervention BEC did
not account for individual differences in the rates at which this
variable changed.
The second step indicated that the main effect for intervention
group was not significant. Greater BEC was reported by younger
participants, participants with more physical impairment, and

642

MANNE ET AL.

those reporting more partner unsupportive behavior. However, in


the third step, there was a significant interaction, F(1, 327) 7.55,
p .0063, involving Time Intervention Group Partner
Unsupportive Behavior (see Figure 2). Preintervention group differences for women who were one standard deviation above or
below the mean on partner unsupportive behavior were not significant. However, for women one standard deviation above the mean
on partner unsupportive behavior at the preintervention assessment, there was a marginally significant, t(225) 1.86, p .0638,
intervention effect in favor of CG (adjusted M 8.91) compared
with UC (adjusted M 9.83) at the first postassessment, and a
significant, t(225) 2.54, p .0018, effect at the second postintervention assessment, again in favor of CG (adjusted M 7.75)
compared with UC (adjusted M 9.55). There were no intervention group differences for women who were one standard deviation
below the mean on partner unsupportive behavior at either postintervention assessment (adjusted MCG Time 2 7.55; adjusted MUC
Time 2 7.73; adjusted MCG Time 3 7.76; adjusted MUC Time
3 7.34). There were no significant moderator effects involving
physical impairment.

Figure 2. Plot of the interaction of Time Intervention Group


Preintervention Unsupportive Partner Behavior on the Mental Health Inventory18 Loss of Behavioral and Emotional Control subscale.

As a result of the significant interaction involving time, the final


model accounted for 32.6% of the variability among the women in
the rates at which BEC declined over time. However, because the
rate parameter was still significant (z 1.74, p .0412), other
variables might account for the individual differences in the rates
at which BEC changed over time.
IES. Results are shown in the fourth panel of Table 3. The first
step indicated significant decline in IES over time, t(348)
6.24, p .0001, and significant individual differences in preintervention IES (z 7.91, p .0001) as well as in the rates at
which IES decreased over time (z 2.94, p .0016). For some
women, the decline was much more rapid than for others. The
covariance between preintervention IES and the rate at which IES
changed over assessments was also significant (z 2.31, p
.0207), indicating that, over time, decreases in IES scores were
slower for women whose IES scores were higher at preintervention. In the second step, the main effect for intervention group was
not significant. Higher IES scores were reported by participants
who were younger, married longer, more educated, and reported
more physical impairment and more partner unsupportive behavior. In the third step, there was a marginally significant, F(1,
208) 3.11, p .0793, Intervention Group Physical Impairment interaction.
Positive well-being. Results are shown in the fifth panel of
Table 3. The first step indicated that there were significant increases in well-being over the study course, t(344) 3.38, p
.0008. There were also significant individual differences in preintervention well-being (z 7.96, p .0001) as well as in the rates
at which well-being changed over time (z 3.11, p .0009). The
covariance between individual differences in preintervention wellbeing and in the rates of change was not significant. The second
step indicated that the main effect for intervention group was not
significant. Greater well-being was reported by older participants,
participants with less physical impairment, and those with lower
partner unsupportive behavior. The third step revealed a significant, F(1, 326) 6.84, p .0093, interaction involving Time
Intervention Group Partner Unsupportive Behavior (see Figure
3). Preintervention group differences for participants who were
one standard deviation above or below the mean on partner unsupportive behavior were not significant. For participants one
standard deviation above the mean on partner unsupportive behavior, there was no significant group difference at the first assessment postintervention, but at the second assessment postintervention, there was a significant effect, t(225) 2.37, p .0185, in
favor of CG (adjusted M 25.38) compared with UC (adjusted
M 22.83). There were no intervention group differences for
participants who were one standard deviation below the mean on
partner unsupportive behavior at either postassessment (adjusted
MCG Time 2 26.82; adjusted MUC Time 2 26.63; adjusted
MCG Time 3 27.33; adjusted MUC Time 3 27.38). There were
no significant moderator effects involving physical impairment.
As a result of the significant interaction involving time, the final
model accounted for 24.2% of the variability among the women in
the rates at which well-being increased over time. However, because the rate parameter was still significant (z 2.43, p .0076),
other variables might account for the individual differences in the
rates at which well-being changed over time.

COUPLE-FOCUSED INTERVENTION

Figure 3. Plot of the interaction of Time Intervention Group


Preintervention Unsupportive Partner Behavior on the Mental Health Inventory18 Positive Well-Being subscale.

Subgroup Analyses
Subgroup analyses compared women attending the couplefocused intervention group with women who did not attend the
group (CG-A) and women assigned to UC. In each subgroup
analysis that follows, the first step involving time as the only
explanatory variable yielded the same results as in the ITT analysis. In addition, the sociodemographic and medical variables in
the ITT continued to be significant in the subgroup analyses. We
examined preintervention differences on all outcomes reported
below, and there were no significant differences. Coefficients for
these analyses can be obtained from the authors as they are not
presented in tabular format here.
Depressive symptoms. Results from the second step, a main
effect model, yielded a significant intervention group effect, F(2,
225) 8.37, p .0003, in favor of CG (adjusted M 8.39)
compared with UC (adjusted M 9.42) and CG-A (adjusted M
9.74) after covariate adjustment. Means for women in the UC and
CG-A groups did not differ from one another. Results from the

643

third step, the moderator analyses, indicated a significant firstorder interaction between intervention group and partner unsupportive behavior, F(2, 223) 4.68, p .0102. For women one
standard deviation above the mean on partner unsupportive behavior, mean depressive symptoms were significantly lower among
women in the CG condition (adjusted M 8.85) compared with
the UC (adjusted M 10.56) and CG-A groups (adjusted M
11.31). The latter two means did not differ from one another. For
women one standard deviation below the mean on partner unsupportive behavior, there were no significant mean differences (adjusted MCG 7.99; adjusted MUC 8.23; adjusted MCG-A
8.25). There were no significant moderator effects involving physical impairment.
Anxiety. In the second step, the main effect for intervention
group was examined by controlling for significant demographic
and medical covariates. Results indicated a significant main effect
for intervention group, F(2, 25) 4.14, p .0171. After covariate
adjustment, average anxiety for CG participants (adjusted M
9.58) was significantly lower than for UC participants (adjusted
M 10.51) and CG-A participants (adjusted M 10.80). Means
for women in the UC and CG-A groups did not differ. The third
step indicated that there were no significant moderator effects
involving intervention group, partner unsupportive behaviors, or
physical impairment.
Loss of BEC. In the second step of the analysis, after the
effects of sociodemographic, medical, and moderator (physical
impairment, unsupportive partner behavior) were included, the
main effect for intervention group yielded significance, F(2,
225) 3.90, p .013, in favor of CG (adjusted M 8.00)
compared with UC (adjusted M 8.78) and CG-A (adjusted M
8.90). The latter two means did not differ. In the third step,
examination of first-order moderator effects indicated a significant
interaction, F(2, 325) 3.94, p .0054, between time and
intervention group. Examination of the means for the three groups
prior to the intervention indicated no differences. However, at the
first assessment postintervention, mean BEC score for those participants in CG (adjusted M 7.93) was significantly lower than
the mean for those in the UC (adjusted M 8.78) or in the CG-A
(adjusted M 9.33) groups. Means for the UC and CG-A groups
did not differ. At the second postintervention assessment, the mean
BEC score for those in CG (adjusted M 7.15) was significantly
lower than mean BEC for those in the UC (adjusted M 8.44) or
the CG-A (adjusted M 9.90) groups. Again, UC and CG-A
means did not differ from one another.
The interaction between intervention group and physical functioning, F(2, 221) 3.51, p .0315, was also significant. Examination of the interaction indicated that for women in the CG
condition, as physical impairment increased, there was a slight
increase in BEC, although this increase was not significant,
t(221) 0.83, p .05. However, for women in the CG-A or UC
groups, greater physical impairment was associated with a significant increase in BEC, tCG-A(221) 4.30, p .0001; tUC(221)
2.36, p .01. A slightly different way of looking at this interaction
is to note that for women who were one standard deviation below
the mean on physical impairment, there were no significant differences among the means (adjusted MCG 7.70; adjusted MUC
7.98; adjusted MCG-A 7.98). However, for women one standard
deviation above the mean on physical impairment, mean BEC was
significantly lower for women in the CG condition (adjusted M

MANNE ET AL.

644

8.17) compared with the UC (adjusted M 9.61) and CG-A


groups (adjusted M 10.72). The latter two means did not differ
from one another. There was a marginally significant interaction,
F(2, 325) 2.83, p .06, involving Time Intervention
Group Partner Unsupportive Behavior.
As a result of the significant interaction involving time, the final
model accounted for 32% of the variability among the women in
the rates at which BEC declined over time. However, because the
rate parameter was still significant (z 2.55, p .0054), other
variables might account for the individual differences in the rates
at which BEC changed over time.
IES. The second step, a main effects model for total IES, did
not indicate a significant intervention group effect. The third step
did not suggest significant interaction effects involving intervention group, partner unsupportive behavior, or physical impairment.
Positive well-being. The second step, the main effects model,
indicated that mean well-being for women in CG (adjusted M
25.94) differed significantly, t(225) 2.89, p .0118, from
women in CG-A (adjusted M 24.92). However, there were no
significant differences in mean well-being scores for women in UC
compared with women in the CG or CG-A conditions.
In the third step, an analysis of first-order moderator effects
yielded a significant, F(2, 326) 4.80, p .0088, Time
Intervention Group interaction. Examination of the means for the
three groups indicated that at preintervention, there were no significant well-being differences. At the first assessment postintervention, the mean well-being score for those in CG (adjusted M
26.16) was significantly higher than the mean for those in the UC
(adjusted M 24.81) and CG-A (adjusted M 23.22) groups. The
means for those in the UC and CG-A groups did not differ. At the
second postintervention assessment, the mean well-being score for
those in CG (adjusted M 27.46) was significantly higher than the
mean well-being scores for those in the UC (adjusted M 25.13)
or the CG-A (adjusted M 23.02) groups. Again, there were no
differences between the UC and CG-A means.
The interaction involving Time Intervention Group Partner
Unsupportive Behavior was marginally significant, F(2, 324)
2.50, p .08. As a result of the interactions involving time, the
final model accounted for 28% of the variability in the rate of
change for well-being. However, the rate parameter was still
significant (z 2.36, p .009), indicating that other variables
might account for the individual differences in the rate at which
well-being changed.

Discussion
This article is the first to report the results of a randomized,
controlled CG intervention designed to reduce distress and improve well-being in women treated for localized breast cancer. As
predicted, the CG intervention had a positive impact on depressive
symptoms. We found some evidence to suggest that the intervention tended to be more beneficial to women rating their partners as
more unsupportive and to women reporting more physical impairment preintervention. Among women rating their partners as more
unsupportive preintervention, women assigned to the CG intervention reported lower loss of BEC symptoms and greater well-being
at follow-up than did women in the UC group. In addition, women
randomized to the intervention group who rated their partners as
more unsupportive reported marginally lower depressive symp-

toms at follow-up compared with women in UC. There were also


marginally lower IES scores among women reporting more physical impairment preintervention in the intervention group compared with women in the UC group. Contrary to prediction, the
couple-focused intervention did not impact other indicators of
distress, including anxiety, loss of BEC symptoms, positive wellbeing, or IES scores. Subgroup analyses conducted to evaluate
whether CG had an effect when women who were randomized to
CG and attended the intervention were compared with intervention
drop-outs and UC suggested that the CG intervention had a beneficial effect on all indicators of distress (except the IES). In these
subgroup analyses, we also found evidence to suggest that the
intervention was more beneficial to women rating their partners as
more unsupportive and to women reporting more physical impairment. The CG intervention resulted in greater reductions in depressive symptoms among women rating their partners as more
unsupportive compared with women in UC and women who were
assigned to the intervention but did not attend any sessions. Furthermore, the CG intervention resulted in greater reductions in loss
of BEC among women reporting more physical impairment compared with women in the UC group or women who were assigned
to the intervention but did not attend sessions.
What can we conclude about the efficacy of the couple-focused
intervention? Primary ITT analyses indicate that the intervention
impacted womens depressive symptoms but not other indicators
of distress and well-being. Because the majority of cognitive
behaviorally oriented group interventions offered to women with
breast cancer are individually focused (e.g., Antoni et al., 2001),
there have been no published randomized clinical trials evaluating
a CG psychosocial intervention approach for women with early
stage breast cancer. Thus, this study represents the first evidence to
suggest that a couple-focused intervention approach may prove
beneficial. It is most important to note that our results suggest that
the impact on womens depressive symptoms is not transitory,
which is a concern that has been noted in prior reviews of intervention studies in this area (Andersen, 2002). Indeed, in the
present study, the reductions in depressive symptoms persisted
over the 6-month follow-up period. Longer term follow-up should
be included in future studies.
It is noteworthy that subgroup analyses comparing women randomized to intervention who attended it, women randomized to
intervention who dropped out, and women assigned to UC indicated a greater number of beneficial effects of the couple-focused
intervention. Beneficial effects of the intervention were noted on
all indicators of general emotional distress for women who attended at least one intervention session compared with women
assigned to UC and women who dropped out of intervention. As
has been pointed out in discussions of methods of handling intervention data, ITT analyses result in the most unbiased interpretation of intervention effects, whereas analyses based on intervention
attenders are likely biased by the fact that individuals randomized
to intervention but who drop out may differ from individuals who
receive intervention (Nich & Carroll, 2002). These differences
distort the interpretation of the efficacy of intervention when
treatment dropouts are not included in the analysis. Thus, in the
present study, the greater number of beneficial effects of CG in the
subgroup analysis may be due to selection bias, despite the comparability of the groups of intervention dropouts, attendees, and
women assigned to UC. It is possible that women who attended

COUPLE-FOCUSED INTERVENTION

CG were more motivated to obtain this intervention; that they


differed on an unmeasured psychological construct, such as optimism, openness and commitment to personal growth, receptiveness to psychotherapy, or benefit-finding; and that these differences resulted in the beneficial response found. Further evidence is
needed before firm conclusions about the efficacy of CG intervention can be drawn. One important fact that may have led to the
differences between the ITT and subgroup analyses findings was
the rate of treatment dropout, which was 35%. Other studies using
ITT analyses did not report as high a rate of intervention dropout
(Helgeson et al., 2000; Nezu et al., 2003). Our dropout rate was
higher because our intervention required both partners attendance
and was offered in a group format (thus, rescheduling was not
possible for one couples absence). It is possible that the higher
treatment dropout influenced our findings more than in results
reported in prior intervention studies.
In both our ITT and subgroup analyses, we found that there may
be women who benefit more from a couple-focused intervention
approach. Women who perceived their partners as more unsupportive prior to the intervention benefited more from this intervention compared with women who reported less unsupportive behavior on the part of their partners. Given that the focus of the groups
content specifically targeted education about constructive and unconstructive communication and expression of support needs, it is
not surprising that women lacking sufficient partner support benefited most. Although not evaluated, a reduction in unconstructive
relationship communication would hopefully have occurred as a
result of the intervention. These findings are consistent with results
suggesting that personal resources, particularly lack of emotional
support received from ones partner, may predict the effectiveness
of psychological interventions (Helgeson et al., 2000).
Although less consistent than our findings for unsupportive
partner behavior, our results also indicated that the CG intervention may be more beneficial for women reporting higher levels of
physical impairment. Women randomized to the CG intervention
who reported more physical impairment at the start of the intervention reported lower IES scores at follow-up. Women rating a
higher level of physical impairment associated with cancer diagnosis and treatment may benefit more from an intervention that
offers the patient and her partner skills to negotiate and discuss
disease-related problems that interfere with the couples daily life.
Taken together with our findings for the moderating effects of
unsupportive partner behavior, our findings are consistent with an
emerging literature on the identification of subgroups of individuals with cancer who might benefit from psychosocial interventions (e.g., Antoni et al., 2001; Cunningham, Lockwood, & Edmonds, 1993; Helgeson et al., 2000; Lepore, Helgeson, Eton, &
Schulz, 2003).
Before closing, it is important to point out limitations and future
directions. It is most important to note that we had a high rate of
study refusal and a relatively high rate of couples who dropped
from the CG condition before the intervention began. The latter
issue may have impacted the studys results in a significant manner. Participants were significantly younger and sicker than study
refusers. Participants who completed all study surveys were older
and married longer than study refusers. However, we did not find
differences between women randomized to the intervention who
attended sessions and women who did not attend sessions. Overall,
the relatively high rate of dropout and refusal raises concern about

645

the acceptability of a CG intervention for women with early stage


breast cancer. Future studies should evaluate whether acceptance
rates would be higher if the intervention were offered after medical
treatment was completed or at the time of initial diagnosis. A
second limitation is our sample composition, which comprised
primarily Caucasian and well-educated couples. Our intervention
may have had a different impact for less educated or minority
couples. A third limitation is the fact that patients were female.
More research is needed regarding potential differences in intervention effects when the patients are male. Finally, our effect sizes
were relatively small (.02 .07).
The clinical significance of these findings awaits further replication of the CG intervention. If ITT analyses replicate an intervention effect, CG intervention for women with early stage breast
cancer may prove useful for clinicians working with this population in the oncology setting. This intervention approach may be
able to best assist those patients who are most in need of help
because of inadequate support in their relationship or more physical side effects from cancer treatment. Future research should
evaluate potential psychological mechanisms for the intervention
effects, as well as determine the efficacy of this intervention when
the partner with cancer is the man and whether our intervention is
efficacious among women with other types of cancer and among
women with more advanced stages of cancer.

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Received April 30, 2004


Revision received December 14, 2004
Accepted December 20, 2004

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