Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
|ClinicalTrials.gov Identifier: NCT02112149|
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : July 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: LIVESTRONG||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Experimental: LIVESTRONG Program
Participants randomized to the LIVESTRONG exercise program will attend a 12-week LIVESTRONG Program at one of the participating YMCA's in the greater Boston area or CT. We will have monthly teleconferences to discuss the study, recruitment, and the exercise program. Lastly, throughout the 12-week program, participants will record their attendance at the LIVESTRONG program as well as any exercise done outside of the program. We will provide them with a Physical Activity Log book to record their exercise.
The LIVESTRONG at the YMCA is a twelve-week, small group (< 16 participants) program designed for adult cancer survivors. YMCA fitness instructors work with each participant to fit the program to their individual needs. The instructors are trained in the elements of cancer, post rehabilitation exercise and supportive cancer care. There are two YMCA fitness instructors overseeing each exercise session. Each session is 90 min in duration, twice per week, for 12-wks (total of 24 sessions). Each session begins with a warm-up, then aerobic exercise (e.g., treadmill) and resistance training exercises, followed by a cool-down period, and follows the recommendations of the American College of Sports Medicine.
No Intervention: Wait-List Control
Baseline data will be collected from all study participants before randomization. If a participant is randomized to wait-list control, then he/she will be told that he/she will start the LIVESTRONG program after three months and after he/she returns to Yale or DFCI to complete the 3-month clinic visit.
- Change in Physical Activity Level [ Time Frame: 3 months ]Modifiable Physical Activity Questionnaire will be used to assess physical activity levels at baseline and 3-months to examine whether the LIVESTRONG program led to maintenance or further increases in physical activity levels compared with participants randomized to control.
- Change in Body Fat Percentage [ Time Frame: 3 months ]Dual-energy X-ray absorptiometry (DEXA) scans will be used to assess body fat percentage, lean body mass, and bone mineral density at baseline and 3-months. Study participants will receive a copy of their 3-month DEXA report.
- Change in Lean Body Mass [ Time Frame: 3 months ]Dual-energy X-ray absorptiometry (DEXA) scans will be used to assess body fat percentage, lean body mass, and bone mineral density at baseline and 3-months. Study participants will receive a copy of their 3-month DEXA report.
- Change in Bone Mineral Density [ Time Frame: 3 months ]Dual-energy X-ray absorptiometry (DEXA) scans will be used to assess body fat percentage, lean body mass, and bone mineral density at baseline and 3-months. Study participants will receive a copy of their 3-month DEXA report.
- Change in Body Mass Index (BMI) [ Time Frame: 3 months ]Height and weight will be measured at baseline and 3-months. Participants will be weighed in light indoor clothing, without shoes, rounding up to the nearest 0.1 kg; height will be measured without shoes, using a stadiometer, rounding up to the nearest 0.1 cm. BMI will be calculated using the formula: kg/m2. All measures will be performed and recorded twice in succession.
- Change in Blood Biomarkers [ Time Frame: 12 weeks ]Fasting blood (> 12 hours) will be collected at baseline and 12 weeks for measurement of insulin, c-reactive protein, leptin and adiponectin, which are biomarkers that have been linked to cancer prognosis in prior studies.
- Change in Walk Distance [ Time Frame: 12 weeks ]All participants will undergo a 6MWT at baseline and after the 12-week protocol period. Participants will wear tennis shoes and will walk indoors along a long, flat, straight, enclosed corridor, on a flat surface for 6 minutes. They will be instructed to walk continuously along an area at least 50 feet in length, back and forth, for 6 minutes.
- Change in Quality of Life [ Time Frame: 12 weeks ]Quality of Life (QOL) will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire (version 3) as well as the PROMISE Q. Breast cancer survivors will also complete the FACT-B-ES form that assesses endocrine-related symptoms specific to breast cancer. Additionally, fatigue will be assessed through the FACT-Fatigue Scale, which consists of 13 items designed to assess fatigue in terms of its intensity and interference with performing everyday functions.
- Lymphedema Questionnaire [ Time Frame: 12 weeks ]Breast cancer survivors will complete a validated Norman Lymphedema Questionnaire. Previous methodologically strong studies have shown exercise, including upper body resistance/strength training, to decrease the risk of exacerbation of lymphedema as well as severity of lymphedema symptoms in breast cancer survivors randomized to a twice-weekly year long strength training program compared with breast cancer survivors randomized to control. Given these findings, breast cancer survivors with lymphedema will not be excluded from participation in the study. However, MD consent to exercise will be obtained from her oncologist.
- Change in Breast Cancer Prevention Trial Symptom Checklist [ Time Frame: 3 months ]The Breast Cancer Prevention Trial Symptom Checklist Short Form is a symptom checklist that will be completed by all study participants at baseline and 3-months to assess side effects/symptoms related to cancer surgery and treatment and how exercise may improve or prevent some of these symptoms. Symptoms such as lymphedema, neuropathy, and arthralgias will be assessed.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112149
|United States, Connecticut|
|New Haven, Connecticut, United States, 06519|
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Melinda L Irwin, PhD, MPH||Yale University|
|Principal Investigator:||Jennifer A Ligibel, MD||Dana-Farber Cancer Institute|