4 Proposal Final

Increased Red/Processed Meat Consumption and Colorectal Cancer Risk in Adults
Ashley Francis Department of Epidemiology and Community Health VCU
Does Increased Consumption of Red/Processed Meats Increase Risk of Colorectal Cancer in Adults?
Elizabeth Costa, Ashley Francis, Alyssa Troeschel, Antonio Villa
TABLE OF CONTENTS I. Abstract II. Introduction III. Methodology a. Design b. Participants c. Recruitment d. Data Collection IV. Data Analysis APPENDIX I. Demographic Scripted Questions II. Medical History Questionnaire III. Food Frequency Questionnaire IV. Tables V. Timeline
Abstract: Introduction: Cancer is the second leading cause of death in the United States, killing approximately 562,875 Americans in 2007. Colorectal cancer (CRC) is the second leading cause of death among cancer related deaths. CRC is cancer that forms in the gastrointestinal tract, specifically in the colon or rectum. Several studies have demonstrated conflicting, but statistically significant, associations between red/processed meat consumption and risk of developing CRC. Purpose: The purpose of this study is to determine whether increased consumption of red meat and processed meats will increase the risk of CRC in adults when evaluated collectively, independently, and comparatively. We aim to provide a clear answer for the conflicting findings that persist among current studies. Design: A case control study is used for cost effectiveness and time conservation, as resources are limited. Cases will be drawn from the Virginia Cancer Registry and controls from the Virginia Department of Motor Vehicles drive registry. All subjects will be between the ages of 41-80 and will meet specific inclusion/exclusion criteria. Odds ratios will assess the relationship between meat consumption levels and CRC risk. Conclusion: Red/processed meat intake is a modifiable risk factor that may decrease incidence and subsequently prevalence of CRC cases in the United States. Data and conclusions collected and generated by this study will allow researchers/clinicians to compare the two meats in order to make recommendations for individuals wishing to modify their behaviors to prevent CRC and/or understand their risk of developing CRC.
Key Words: Colorectal cancer, colon cancer, rectal cancer, red meats, processed meats.
Introduction Colorectal cancer (CRC) is the second leading cause of cancer death in the United States affecting both men and women of all races and ethnicities.1 CRC is cancer that forms in the tissues of the colon or rectum. In 2007, 53,219 deaths were attributed to colorectal cancer; while approximately 142,672 people were newly diagnosed with colorectal cancer.2 More than 90% of cases occur in individuals 50 years or older. In addition to age, other risk factors include family history of the disease, inflammatory bowel disease, and genetic alterations. Precancerous colorectal polyps, abnormal growths on the inner wall, are often present in the colon before invasive cancer develops. If CRC is detected and treated early, the five-year survival rate is 90%. 2 Several existing studies found associations between both processed and red meats and an increased risk of colorectal cancer. Norat et al. found that increased intake of both red and processed meats showed a significantly increased risk of colorectal cancer. 3 Another study found that individuals in the highest quintile of red and processed meat consumption had a higher risk of CRC than those individuals in lower quintiles, possibly displaying a dose-response relationship. 4 In contrast, other studies report no statistically significant associations between red meat consumption and the risk of CRC. 5 However, when red and processed meats are analyzed separately, processed meat consumption showed a significant association with risk of CRC. 3 Similarly, another study found only processed meats are shown to have a significant association with an increased risk of CRC. In contrast, researchers from a different study showed that only red meat is significantly associated with increased risk of CRC. 6,7 Statistical associations have
also been attributed to race in either the African American or Caucasian participants, it was determined that total protein content significantly reduced the risk of CRC in Caucasians. 8 The current data suggest a possible association between the consumption of red meat and/or processed meat and colorectal cancer; however, current studies do not address the scope of possible risk factors. Very few studies analyze red and processed meat consumption separately, collectively, and comparatively. To overcome past limitations, our study aims to determine whether increased consumption of red meat and processed meats will increase the risk of colorectal cancer in adults when evaluated collectively, independently, and comparatively while also adjusting for potential confounding factors. Methods Design: A population-based, case-control study will evaluate the relationship between red/processed meat consumption and risk of colorectal cancer in adults. CRC often has a long induction and latent period, which may present difficulties with follow up time. Due to the complexity of following through time, case control methodology was selected. We reviewed 20 articles to help understand the relationship between dietary patterns and colorectal cancer. The literature studied reflected diet-related factors associated with red meat risk among different dietary patterns. 9,10 A case-control study design will allow us to effectively investigate the relationship between red/processed meats and risk of CRC in a timely manner using limited resources. The sample cases will be selected through Virginia Cancer Registry (VCR) provided by the Virginia Department of Health, while sample controls will be randomly selected through Virginia Department of Motor Vehicles driver registry. Red/processed meat intake data will be collected and assessed by interviewing study participants over the telephone. The attached
medical history/demographic interview and food frequency questionnaire (FFQ) will be used for data collection. The data collected will be useful in promoting colorectal cancer screening and preventing future colorectal cancer. IRB approval is not necessary for the current study as there is no intervention component and poses less than minimal risk. Subjects: Study participants will be selected from various areas throughout the Commonwealth of Virginia, which include rural, suburban and urban areas with a diverse socioeconomic population. All case participants will be identified through the Virginia Department of Healths Virginia Cancer Registry (VCR). All cases must have histologically confirmed invasive adenocarcinoma of the colon or rectum first diagnosed between January 1, 2000 and January 1, 2011, be between the ages of 41-80, hold a valid Virginia drivers license, have the ability to give informed consent and complete a short telephone interview regarding diet and medical history.8 All control participants will be randomly selected through Virginia Department of Motor Vehicles driver registry. Eligibility criteria for controls includes holding a valid Virginia drivers license, between the ages of 41-80 (as colorectal cancer is typical in adults starting at age 50 for Caucasians and 45 for African Americans), and have the ability to give informed consent and complete a telephone interview regarding diet and medical history. 8 Exclusion criteria for both cases and controls includes those participants who have inadequate or incomplete data from the FFQ, self-reported end stage renal disease, a family history of colorectal cancer, have previously been diagnosed with Crohns Disease or Ulcerative Colitis, have prior cancer (aside from current diagnosis of colorectal cancer), are institutionalized, and either consume less than 900 kcal each day or greater than 4000 kcal per day. Additional
exclusion criteria for control participants include having prior cancer of any kind including diagnosis of colorectal cancer. 7,8
Recruitment: Approximately 6,000 recruitment contacts will be made for cases and 2,000 for controls, estimating a 30% response rate for cases and 50% response rate for controls to recruitment. Approximately 1,800 cases and 1,000 controls will be surveyed and assessed by nurses. Assuming a 30% response rate in cases and 50% response rate in controls, approximately 540 cases and 500 controls will be used. Cases are estimated to have a lower response rate due to the burden of cancer and medical needs. Therefore, oversampling of cases and compensation for participation (for cases and controls) will strive to mitigate non-response, attrition, and failure to participate. Subjects will receive $30 for their participation in survey and assessment. Exposure Assessment: Interviews will be conducted via telephone to obtain diet and medical
history/demographic information. Trained interviewers will be responsible for collecting the data and following a script to eliminate interviewer bias. The interview will be focused on dietary intake and eating patterns. Based on the observations received, cut-offs will be
established for high, moderate, and low red/processed meat intake.
Data Collection: Once the subjects are identified and have signed the informed consent document, the subjects will be asked to provide a phone number in order to conduct the telephone interview. A member of the research team will then contact each of the subjects and go through the
standardized participant characteristics and medical history with the subject and standardized FFQ. The questionnaire concerning demographics and medical history (See Appendices 1&2) will be given to participants during the first part of the telephone interview. Each participant will answer a series of 12 question regarding race/ethnicity, age, weight, height, gender, birthday, marital status, annual income, education level, various medical conditions and lifestyle behaviors. Questions regarding participant characteristics were adopted and modified from the National Health and Nutrition Examination Survey available questionnaires concerning demographics and medical conditions. 11 During the second part of the telephone interview, each subject will complete a food frequency questionnaire (FFQ) concerning frequency of red and processed meat consumption (See Appendix 3). 11 The dietary information collected will focus on the participants average total consumption during the past year for various types of meats to determine if a relationship exists between increased red/processed meat consumption and risk of colorectal cancer in adults. For cases, the questions will be answered regarding the year prior to diagnosis. The FFQ, as compared to a 24-hour recall, was chosen as the method of data collection because the 24-hour recall may not adequately describe the subjects average red/processed meat intake. The FFQ will also help minimize the day-to-day variability that would have to be taken into account if a 24-hour recall was to be used. The FFQ will include questions on each specific type of meat taking into account serving size, as well as specific cooking methods. The participants will chose from one of eight categories that best describes their usual food intake: never, less than once per month, 1-3 times per month, once per week, 2-4 times per week, 5-6 times per week, once per day, or two or more servings per day. Red/processed meat intake will be calculated based on the frequency of
consumption and serving size for all types of red meat (beef, pork, steak, and lamb) and processed meats (bacon, sausage, cold cuts, ham, hamburger, hot dogs, liver, and luncheon meats). The questionnaire also takes into account complex meals with red/processed meat such as stew, casserole, lasagna, etc. Strengths/Limitations: Recall bias is an inevitable limitation in this study and may be present in both cases and controls. Cases will respond based on their food intake the year prior to diagnosis, consequently this may potentially be up to eleven years in the past and recall may be difficult and/or inaccurate. An additional weakness in our study is due to the long induction and latency period of CRC, causing difficulties with follow up time. Also, oversampling in cases may introduce bias as they may be over represented in the sample. Controlling for the following confounders will strive to eliminate the bias introduced by oversampling: age, sex, race, marital and smoking status, alcohol intake, BMI, and poverty level/income. Observational bias will be eliminated through blinding. Interviewers will be blinded as to whether the patient they are assessing is a case or control. Participants will also be blinded to the extent of not knowing which risk factor is being assessed in order to eliminate further response bias. The strength of this study as compared with others of its kind, is the ability to not only assess the associations of red/processed meat with CRC independently and collectively, but to also assess them comparatively. Additionally, using the FFQ as opposed to a 24-hour dietary recall is more reflective of dietary behavior. This study aims to allow researchers/clinicians to compare the two meats in order to make recommendations for individuals wishing to modify their behaviors to prevent CRC and/or understand their risk of developing CRC. Our interview questionnaire asks numerous in depths questions that could potentially be used for future studies.
9
Data Analysis: After the study participants have answered the questions in the FFQ, the survey results will be entered into the Statistical Analysis Software (SAS) computer program. BMI will be calculated from the results of the height and weight questions of the questionnaire. The statistical analysis will allow researchers to accurately determine all frequencies, percentages, means, and standard deviations. The current study tests the hypotheses that (1) red meat intake (low intake, moderate intake, high intake) and CRC (yes, no) are related, (2) processed meat intake (low intake, moderate intake, high intake) and CRC (yes, no) are related, (3) red and processed meat intake (low intake, moderate intake, high intake), collectively, and CRC (yes, no) are related. Potential confounding factors such as age, sex, race/ethnicity, marital status, poverty level/income, smoking status, alcohol consumption and BMI will be categorized in accordance to the literature.
3,5,12
To test the association between CRC and the independent variables, a
bivariate analysis will be conducted and odds ratios and 95% confidence intervals will be calculated. Researchers will analyze red and processed meats independently, comparatively and collectively. A dose response relationship will be examined by assessing the odds ratios. Multiple logistic regressions will be conducted to adjust for age, sex, race/ethnicity, marital status, income, smoking status, alcohol consumption and BMI.
3
This will allow researchers to
separately compare associations of red meat and colorectal cancer risk across different variables that may have a preexisting association with colorectal cancer. A significance level of 0.05 will be used in this study.
10
Appendix 1 Script: Hi, this is ___________ from the Colorectal Cancer study at VCU. I am calling because you agreed to answer a few questions concerning your diet. Do you have a few minutes to answer some questions? [If response is no, ask when a good time to call back is. If response is yes, proceed] Ok, great and thank you. As a reminder, you are not required to answer any of the questions and may ask to skip any questions that make you uncomfortable. Demographic Scripted Questions 1. Your gender is: 1. Male 2. Female 7. Refused 9. Dont Know 2. Your ethnicity is: 1. Non-Hispanic White 2. Non-Hispanic Black 3. Asian American or Oriental 4. Hispanic or Latino 5. Other 7. Refused 9. Dont Know 3. Date of Birth: ____________________________________ 4. How much do you weigh? __________ 5. How tall are you? ___________ 6. Are you currently married, widowed, divorced, separated, never married or living with a partner?
11
1. Married 2. Widowed 3. Divorced 4. Separated 5. Never Married 6. Living with Partner 7. Refused 9. Dont Know 7. What is the highest grade or level of school you have completed or the highest degree you have received? 1. Some High school or less 2. High school graduate, or GRE equivalent 3. Some college, no degree 4. Associate Degree 5. College Graduate or higher 7. Refused 9. Dont Know 8. What is your head of households annual income? 1. Under $20,000 2. Over $20,000 7. Refused 9. Dont Know 9. What is your total household annual income? _________________ 10. How many people currently live in your household (including yourself)? ________________
12
11. Do you currently or have you ever smoked? 1. Never 2. Ex-Smoker 3. Current Smoker 7. Refused 9. Dont Know 12. On average, how many alcoholic beverages do you consume per week? (Note: a drink of alcohol is 1 can of beer, 1 glass of wine, 1 can or bottle of wine cooler, 1 cocktail or 1 shot of liquor) 1. None 2. Less than 4 drinks 3. More than 4 drinks 7. Refused 9. Dont Know
13
Appendix II Medical History 1. Have you ever been told you have end stage renal disease? 1. Yes 2. No 7. Refused 9. Dont Know 2. Have you ever been told by a doctor or other health professional that you had cancer or a malignancy of any kind? 1. Yes 2. No 7. Refused 9. Dont Know If yes, answer: What kind of cancer was it? 1. Bladder 2. Blood 3. Bone 4. Brain 5. Breast 6. Cervix 7. Colon 8. Esophagus 9. Gallbladder 10. Kidney 11. Larynx/ windpipe
14
12. Leukemia 13. Liver 14. Lung 15. Lymphoma/ Hodgkins Disease 16. Melanoma 17. Mouth/tongue/lip 18. Nervous system 19. Ovary 20. Pancreas 21. Prostate 22. Rectum 23. Skin (non-melanoma) 24. Skin (dont know what kind) 25. Soft Tissue (muscle fat) 26. Stomach 27. Testis 28. Thyroid 29. Uterus 30. Other 21. More than 3 kinds 77. Refused 99. Dont Know
15
Appendix III Food Frequency Questionnaire Please complete the following questionnaire to the best of your ability. Please indicate your average total use, during the past 12 months, for each specified food. Please listen to all of the choices before giving us your answer. 1. Bacon (2 slices) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 2. Chicken or turkey sandwich or frozen dinner 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know
16
99. Refused 3. Other chicken or turkey, with skin (3 oz.) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 4. Other chicken or turkey, including ground without skin (3 oz.) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 5. Beef or pork hot dogs (1) 1. Never
17
2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 6. Chicken or turkey hot dogs or sausages (1) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 7. Salami, bologna, or other processed meat sandwiches 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week
18
5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 8. Other processed meats, e.g. sausage, kielbasa, etc. (2 oz. or 2 small links) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 9. Hamburger, lean or extra lean (1 patty) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day
19
8. 2 or more servings per day 77. Dont know 99. Refused 10. Hamburger, regular (1 patty) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused
11. Beef, pork, or lamb as a sandwich or mixed dish, e.g. stew, casserole, lasagna, frozen dinner, etc. 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day
20
77. Dont know 99. Refused 12. Pork as main dish, e.g., ham or chops (4-6 oz.) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 13. Beef or lamb as a main dish, e.g., steak, roast (4-6 oz.) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 14. Liver: beef, calf or pork (4 oz.)
21
1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused 15. Liver: chicken or turkey (1 oz.) 1. Never 2. Less than once per month 3. 1-3 times per month 4. Once per week 5. 2-4 times per week 6. 5-6 times per week 7. Once per day 8. 2 or more servings per day 77. Dont know 99. Refused
22
Appendix IV Tables: Table 1: Summary of Participant Characteristics

Characteristic Cases (n=540) Gender --no. (%) Male Female Age --no. (%) 41-50 51-60 61-70 71-80 Education --no. (%) Less than HS HS graduate or GED Some college or Associates College graduate or higher Race/Ethnicity Non-Hispanic White Non-Hispanic Black Hispanic Other BMI (kg/m2) --no. (%) Underweight <18.5 Normal 18.5-24.9 Overweight 25-29.9 Obese > 30 Marital Status --no. (%) Married/living with partner Widowed/divorced/separated Never married Annual Income Under $20,000 Over $20,000 Smoking Never Ex-Smoker Current Alcohol <4 drink/week > 4 drinks/week Controls (n=500) Odds Ratio 95% CI
23
Table 2: Crude and Adjusted Summary of Associations

Crude Odds Ratio Red Meat Intake Low Moderate High Processed Meat Intake Low Moderate High Red/Processed Meat Intake Low Moderate High Adjusted Odds Ratio 95% CI
95% CI
24
Appendix V.
Research Proposal Timeline: Activities Submit Proposal X Identify all case participants in the Virginia Cancer Registry (VCR) at the Virginia Department of Health Identify all controls in the Virginia Department of Motor Vehicles driver registry Call both group of the participants and ask for consents, and interview (inclusion) Training/2nd Questionnaire complete a food frequency questionnaire (FFQ) X X X X 11/11 11/11 12/11 1/12 2/12 3/12 4/12 5/12 6/12
Data Collection X Collect complete surveys X
Data input into SAS X X
25
Data Analysis X Final Submission to advisor X Presentation X
Note: Monthly progress reports and collaboration with advisor.
26
References
1. Colon and Rectal Cancer page. National Institutes of Health Web site.
http://www.cancer.gov/cancertopics/types/colon-and-rectal. Accessed September 15, 2011.

2. Colorectal (Colon) Cancer page. Centers for Disease Control and Prevention Web site.
http://www.cdc.gov/cancer/colorectal/index.htm. Accessed September 15, 2011.

3. Norat T, Bingham S, Ferrari P, Slimani N, Jenab N. Meat, Fish, and Colorectal Cancer
Risk: the European Prospective Investigation into Cancer and Nutrition. Journal of the National Cancer Institute. 2005; 97(12): 906-916.
4. Cross AJ, Leitzmann MF, Mitchell GH, Hollenbeck AR, Schatzkin A, Sinha R. A
Prospective Study of Red and Processed Meat Intake in Relation to Cancer Risk. PLoS Med. 2007; 4(12): e325.
5. Tabatabaei S, Fritschi L, Knuiman M, Boyle T, Iacopetta B. Meat consumption and
cooking practices and the risk of colorectal cancer. European Journal of Clinical Nutrition. 2011; 65(6), 668-675.
6. Goldbohm R, Van Den Brandt P, Van 't Veer P, et al. A Prospective Cohort Study on the
Relation Between Meat Consumption and the Risk of Colon Cancer. Cancer Research. 1994; 54(3), 718-723.
7. Flood A, Rastogi T, Wirfalt W, et al. Dietary Patterns as Identified by Factor Analysis
and Colorectal Cancer Among Middle-Aged Americans. The American Journal of Clinical Nutrition. 2008; 88:176 84. 8. Williams C, Satia J, Adair L, et al. Associations of Red Meat, Fat and Protein Intake with Distal Colorectal Cancer Risk. Nutrition & Cancer. 2010; 62(6), 701- 709. 9. Larsson S, Rafter J, Holmberg L, Bergkvist L, Wolk A. Red Meat Consumption and Risk of Cancers of the Proximal Colon, Distal Colon and Rectum: the Swedish Mammography Cohort. International Journal Of Cancer. 2005; 113(5), 829-834. 10. Miller P, Lesko S, Muscat J, Lazarus P, Hartman T. Dietary patterns and colorectal adenoma and cancer risk: a review of the epidemiological evidence. Nutrition & Cancer. 2010;62(4):413-424. 11. NHANES- National Health and Nutrition Examination Survey. Atlanta, GA: Centers for Disease Control and Prevention; 2009. http://www.cdc.gov/nchs/nhanes/nhanes2005-2006/nhanes05_06.htm. Updated July 9, 2009. Accessed November 9, 2011.
27
12. Makambi K, Angurs-Collins T, Bright-Gbebry M, et al. Dietary Patterns and the Risk of Colorectal Adenomas: The Black Womens Health Study. Cancer Epidemiol Biomarkers Prev. 2011; 20:818-825.
28

4 Proposal Final

Enviado por

Dados do documento

Título original

Direitos autorais

Formatos disponíveis

Compartilhar este documento

Compartilhar ou incorporar documento

Opções de compartilhamento

Você considera este documento útil?

Este conteúdo é inapropriado?

Direitos autorais:

Formatos disponíveis

4 Proposal Final

Enviado por

Direitos autorais:

Formatos disponíveis

Increased Red/Processed Meat Consumption and Colorectal Cancer Risk in Adults

Ashley Francis Department of Epidemiology and Community Health VCU

established for high, moderate, and low red/processed meat intake.

To test the association between CRC and the independent variables, a

This will allow researchers to

Appendix IV Tables: Table 1: Summary of Participant Characteristics

Table 2: Crude and Adjusted Summary of Associations

Data Collection X Collect complete surveys X

Data input into SAS X X

Data Analysis X Final Submission to advisor X Presentation X

Note: Monthly progress reports and collaboration with advisor.

http://www.cancer.gov/cancertopics/types/colon-and-rectal. Accessed September 15, 2011.

http://www.cdc.gov/cancer/colorectal/index.htm. Accessed September 15, 2011.

Você também pode gostar