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| ID | Type | Description | Link |
|---|---|---|---|
| 427-2012 | Other Identifier | UF IRB 01 |
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Breast cancer risk, and risk of related health problems (e.g., heart disease), is highest among women with a history of breast cancer (stages 1-3) who are also overweight or obese. The purpose of this study is to compare a tailored nutrition, physical activity, and behavioral weight management program for breast cancer survivors against a widely available commercial weight management program. We hypothesize that an intervention tailored to the unique psychological, nutritional and physical needs of breast cancer survivors will provide superior physiological and psychological benefits compared to an existing commercial program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tailored Lifestyle Intervention (TLI) | Experimental | Participants randomized to the TLI condition will receive a 3-month weight management program tailored to the specific needs of women in remission from breast cancer. |
|
| Commercial Weight Loss Program (CLWP) | Active Comparator | Participants randomized to the CWLP condition will receive a 3-month commercial weight loss program (i.e., Weight Watchers) at no cost. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tailored Lifestyle Intervention (TLI) | Behavioral | The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from baseline to post-intervention | baseline (month 0), post-intervention (month 3) | |
| Change in body weight from post-intervention to follow-up | post-intervention (month 3), follow-up (month 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention | baseline (month 0), post-intervention (month 3) | |
| Change in HDL Cholesterol from baseline to post-intervention | baseline (month 0), post-intervention (month 3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Mathews, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States | ||
| University of North Florida |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9180149 | Background | Pharoah PD, Day NE, Duffy S, Easton DF, Ponder BA. Family history and the risk of breast cancer: a systematic review and meta-analysis. Int J Cancer. 1997 May 29;71(5):800-9. doi: 10.1002/(sici)1097-0215(19970529)71:53.0.co;2-b. | |
| 12897329 | Background | McTiernan A. Behavioral risk factors in breast cancer: can risk be modified? Oncologist. 2003;8(4):326-34. doi: 10.1634/theoncologist.8-4-326. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| D015431 | Weight Loss |
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Commercial Weight Loss Program (CWLP) | Behavioral | This intervention is a generic, widely-available weight management program. |
|
| Change in blood glucose control from baseline to post-intervention. | HgA1c and fasting glucose to assess blood glucose control | baseline (month 0), post-intervention (month 3) |
| Change in caloric intake from baseline to post-intervention. | National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake. | baseline (month 0), post-intervention (month 3) |
| Change in body composition from baseline to post-intervention. | Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc). | baseline (month 0), post-intervention (month 3) |
| Change in waist circumference from baseline to post-intervention. | Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation. | baseline (month 0), post-intervention (month 3) |
| Change in sagittal abdominal diameter from baseline to post-intervention. | Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation. | baseline (month 0), post-intervention (month 3) |
| Change in physical activity from baseline to post-intervention. | Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ). | baseline (month 0), post-intervention (month 3) |
| Change in health-related quality of life from baseline to post-intervention. | Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23). | baseline (month 0), post-intervention (month 3) |
| Change in self-efficacy from baseline to post-intervention. | Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire. | baseline (month 0), post-intervention (month 3) |
| Use of weight management strategies | The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ). | post-intervention (month 3) |
| Height | Height will be assessed in order to determine BMI. | baseline (month 0) |
| Change in blood pressure from baseline to post-intervention. | Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes. | post-intervention (month 3), follow-up (month 9) |
| Change in LDL cholesterol at from baseline to post-intervention. | baseline (month 0), post-intervention (month 3) |
| Change in total cholesterol from baseline to post-intervention. | baseline (month 0), post-intervention (month 3) |
| Change in triglycerides from baseline to post-intervention. | baseline (month 0), post-intervention (month 3) |
| Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from post-intervention to follow-up. | post-intervention (month 3), follow-up (month 9) |
| Change in HDL Cholesterol from post-intervention to follow-up. | post-intervention (month 3), follow-up (month 9) |
| Change in blood glucose control from post-intervention to follow-up. | post-intervention (month 3), follow-up (month 9) |
| Change in caloric intake from post-intervention to follow-up. | National Cancer Institute's Automated Self-Administered 24-hour recall system (ASA-24)will be utilized to assess dietary intake. | post-intervention (month 3), follow-up (month 9) |
| Change in body composition from post-intervention to follow-up. | Body composition will be assessed using air displacement plethysmography (Bodpod, COSMED, Inc). | post-intervention (month 3), follow-up (month 9) |
| Change in waist circumference from post-intervention to follow-up. | Waist circumference will be measured in triplicate at the top of the iliac crest using a tension controlled tape measure upon exhalation. | post-intervention (month 3), follow-up (month 9) |
| Change in sagittal abdominal diameter from post-intervention to follow-up. | Sagittal abdominal diameter will be measured in triplicate using a Holtain Kahn caliper at the top of the iliac crest upon exhalation. | post-intervention (month 3), follow-up (month 9) |
| Change in physical activity from post-intervention to follow-up. | Physical activity will be assessed using both objective measurement (via triaxial accelerometer) and subjective assessment (via the International Physical Activity Questionnaire, or IPAQ). | post-intervention (month 3), follow-up (month 9) |
| Change in health-related quality of life from post-intervention to follow-up. | Health-related quality of life will be assessed using the European Organization of Research and Treatment of Cancer - Quality of Life (QLQ-30) and the breast-cancer specific addendum (BR-23). | post-intervention (month 3), follow-up (month 9) |
| Change in self-efficacy from post-intervention to follow-up. | Self-efficacy to abstain from eating in a variety of situations will be assessed using the Weight Efficacy Lifestyle (WEL) questionnaire. | post-intervention (month 3), follow-up (month 9) |
| Use of weight management strategies at follow-up. | The frequency of participants' utilization of specific weight management strategies will be assessed using the Weight Management Questionnaire (WMQ). | follow-up (month 9) |
| Change in blood pressure from post-intervention to follow-up. | Systolic and diastolic blood pressure will be assessed at each time point using an appropriately sized cuff after the participant has been sitting quietly for at least 10 minutes. | post-intervention (month 3), follow-up (month 9) |
| Change in LDL cholesterol at from post-intervention follow-up | post-intervention (month 3), follow-up (month 9) |
| Change in total cholesterol from post-intervention to follow-up. | post-intervention (month 3), follow-up (month 9) |
| Change in triglycerides from post-intervention to follow-up. | post-intervention (month 3), follow-up (month 9) |
| Jacksonville |
| Florida |
| 32224 |
| United States |
| 14576434 | Background | King MC, Marks JH, Mandell JB; New York Breast Cancer Study Group. Breast and ovarian cancer risks due to inherited mutations in BRCA1 and BRCA2. Science. 2003 Oct 24;302(5645):643-6. doi: 10.1126/science.1088759. |
| 12711737 | Background | Calle EE, Rodriguez C, Walker-Thurmond K, Thun MJ. Overweight, obesity, and mortality from cancer in a prospectively studied cohort of U.S. adults. N Engl J Med. 2003 Apr 24;348(17):1625-38. doi: 10.1056/NEJMoa021423. |
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| 19366908 | Background | Nichols HB, Trentham-Dietz A, Egan KM, Titus-Ernstoff L, Holmes MD, Bersch AJ, Holick CN, Hampton JM, Stampfer MJ, Willett WC, Newcomb PA. Body mass index before and after breast cancer diagnosis: associations with all-cause, breast cancer, and cardiovascular disease mortality. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1403-9. doi: 10.1158/1055-9965.EPI-08-1094. Epub 2009 Apr 14. |
| 18648983 | Background | Gallicchio L, Kalesan B, Hoffman SC, Helzlsouer KJ. Non-cancer adverse health conditions and perceived health and function among cancer survivors participating in a community-based cohort study in Washington County, Maryland. J Cancer Surviv. 2008 Mar;2(1):12-9. doi: 10.1007/s11764-008-0046-1. Epub 2008 Feb 12. |
| 18648982 | Background | Fossa SD, Vassilopoulou-Sellin R, Dahl AA. Long term physical sequelae after adult-onset cancer. J Cancer Surviv. 2008 Mar;2(1):3-11. doi: 10.1007/s11764-007-0039-5. Epub 2007 Dec 4. |
| 15767532 | Background | Chen Z, Maricic M, Bassford TL, Pettinger M, Ritenbaugh C, Lopez AM, Barad DH, Gass M, Leboff MS. Fracture risk among breast cancer survivors: results from the Women's Health Initiative Observational Study. Arch Intern Med. 2005 Mar 14;165(5):552-8. doi: 10.1001/archinte.165.5.552. |
| 15850868 | Background | Coups EJ, Ostroff JS. A population-based estimate of the prevalence of behavioral risk factors among adult cancer survivors and noncancer controls. Prev Med. 2005 Jun;40(6):702-11. doi: 10.1016/j.ypmed.2004.09.011. |
| 16314649 | Background | Bellizzi KM, Rowland JH, Jeffery DD, McNeel T. Health behaviors of cancer survivors: examining opportunities for cancer control intervention. J Clin Oncol. 2005 Dec 1;23(34):8884-93. doi: 10.1200/JCO.2005.02.2343. |
| 21338735 | Background | Robien K, Demark-Wahnefried W, Rock CL. Evidence-based nutrition guidelines for cancer survivors: current guidelines, knowledge gaps, and future research directions. J Am Diet Assoc. 2011 Mar;111(3):368-75. doi: 10.1016/j.jada.2010.11.014. No abstract available. |
| 12490959 | Background | Coussens LM, Werb Z. Inflammation and cancer. Nature. 2002 Dec 19-26;420(6917):860-7. doi: 10.1038/nature01322. |
| 11866137 | Background | Shacter E, Weitzman SA. Chronic inflammation and cancer. Oncology (Williston Park). 2002 Feb;16(2):217-26, 229; discussion 230-2. |
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| 20880127 | Background | Vance V, Mourtzakis M, McCargar L, Hanning R. Weight gain in breast cancer survivors: prevalence, pattern and health consequences. Obes Rev. 2011 Apr;12(4):282-94. doi: 10.1111/j.1467-789X.2010.00805.x. Epub 2010 Sep 29. |
| D001836 |
| Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |