My Lifestyle Intervention of Food and Exercise

Breast Cancer Clinical Trial

— MyLIFE  

Official title:

Preventing Breast Cancer Recurrence Through a Tailored Lifestyle Intervention.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01630499
• Other study ID #: MyLIFE2012
• Secondary ID: 427-2012
• Status: Completed
• Phase: N/A
• First received: June 22, 2012
• Last updated: September 28, 2016
• Start date: October 2012
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female

• Age 21 to 65

• History of stage 1, 2, or 3 breast cancer

• Completed primary treatments (chemotherapy, radiation, and/or surgical treatment) for breast cancer (with or without maintenance therapy) within the last 3 months to 5 years of providing consent

• Be willing/able to attend groups and assessments in Gainesville or Jacksonville

• BMI of 27 to 45 kg/m2

• Weight-stable, i.e., not lost/gained = 10 lbs in the preceding 6 months, or since the end of primary treatment

Exclusion Criteria:

• History of bariatric surgery

• Pregnant, lactating, or planning on becoming pregnant in next 12 months.

• Irritable bowel syndrome

• Serious infectious disease

• Chronic malabsorption syndrome

• Uncontrolled angina within the past 6 months

• History of musculo-skeletal or chronic lung diseases that limit physical activity

• Serum creatinin > 1.5 mg/dL

• Uncontrolled or insulin-dependent diabetes (i.e., hemoglobin A1c< 10 g/dL, fasting serum triglycerides > 400 mg/dL; oral medications are not exclusionary)

• At-rest blood pressure > 140/90 mg/Hg

• Myocardial infarction

• Stroke

• Congestive heart failure

• Chronic hepatitis

• Cirrhosis

• Chronic pancreatitis

• History of solid organ transplantation

• Cancer treatment within past 5 years (other than for breast cancer)

• Any other physical condition (other than history of breast cancer) deemed likely to limit 5-year life expectancy or significantly interfere with individuals' ability to participate in a lifestyle intervention involving eating and physical activity changes.

• Use of antipsychotic medications, monoamine oxidase inhibitors, systemic corticosteroids, human immunodeficiency virus or tuberculosis antibiotics, chemotherapeutics medications, or weight-loss medications.

• Significant psychiatric disorder

• Illicit drug use or excessive use of alcohol (i.e., > 2 drinks/day)

• Currently participating in Weight Watcher's or another weight loss program

• Currently participating in another research study

• Unable to read English at the 5th grade level

• Unable/unwilling to provide informed consent

• Unwilling to receive random assignment to TLI or CWLP

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Tailored Lifestyle Intervention (TLI)
The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
• Commercial Weight Loss Program (CWLP)
This intervention is a generic, widely-available weight management program.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida
United States	University of North Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View Citation

Berclaz G, Li S, Price KN, Coates AS, Castiglione-Gertsch M, Rudenstam CM, Holmberg SB, Lindtner J, Erien D, Collins J, Snyder R, Thürlimann B, Fey MF, Mendiola C, Werner ID, Simoncini E, Crivellari D, Gelber RD, Goldhirsch A; International Breast Cancer Study Group. Body mass index as a prognostic feature in operable breast cancer: the International Breast Cancer Study Group experience. Ann Oncol. 2004 Jun;15(6):875-84. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Coussens LM, Werb Z. Inflammation and cancer. Nature. 2002 Dec 19-26;420(6917):860-7. Review. — View Citation

Flegal KM, Carroll MD, Ogden CL, Curtin LR. Prevalence and trends in obesity among US adults, 1999-2008. JAMA. 2010 Jan 20;303(3):235-41. doi: 10.1001/jama.2009.2014. Epub 2010 Jan 13. — View Citation

Fosså 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. Review. — View Citation

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. — View Citation

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. — View Citation

McTiernan A. Behavioral risk factors in breast cancer: can risk be modified? Oncologist. 2003;8(4):326-34. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Shacter E, Weitzman SA. Chronic inflammation and cancer. Oncology (Williston Park). 2002 Feb;16(2):217-26, 229; discussion 230-2. Review. — View Citation

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. Review. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight from baseline to post-intervention		baseline (month 0), post-intervention (month 3)	No
Primary	Change in body weight from post-intervention to follow-up		post-intervention (month 3), follow-up (month 9)	No
Secondary	Change in inflammatory/metabolic disease markers associated with breast cancer recurrence from baseline to post-intervention		baseline (month 0), post-intervention (month 3)	No
Secondary	Change in HDL Cholesterol from baseline to post-intervention		baseline (month 0), post-intervention (month 3)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Height	Height will be assessed in order to determine BMI.	baseline (month 0)	No
Secondary	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)	No
Secondary	Change in LDL cholesterol at from baseline to post-intervention.		baseline (month 0), post-intervention (month 3)	No
Secondary	Change in total cholesterol from baseline to post-intervention.		baseline (month 0), post-intervention (month 3)	No
Secondary	Change in triglycerides from baseline to post-intervention.		baseline (month 0), post-intervention (month 3)	No
Secondary	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)	No
Secondary	Change in HDL Cholesterol from post-intervention to follow-up.		post-intervention (month 3), follow-up (month 9)	No
Secondary	Change in blood glucose control from post-intervention to follow-up.		post-intervention (month 3), follow-up (month 9)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	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)	No
Secondary	Change in LDL cholesterol at from post-intervention follow-up		post-intervention (month 3), follow-up (month 9)	No
Secondary	Change in total cholesterol from post-intervention to follow-up.		post-intervention (month 3), follow-up (month 9)	No
Secondary	Change in triglycerides from post-intervention to follow-up.		post-intervention (month 3), follow-up (month 9)	No