Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors

Study Overview
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Brief Summary
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The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors.

Detailed Description
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The proposed study is a randomized trial evaluating the impact of the 12-week LIVESTRONG exercise program vs. waitlist control on cancer-related outcomes in 200 cancer survivors. Participants will undergo baseline testing at Dana-Farber or Yale, including administration of questionnaires to assess quality of life and the presence of cancer and treatment-related symptoms, fasting blood draw, and evaluation of body composition (using dual energy X-ray absorptiometry (DEXA). Participants will then take part in the 12-week LIVESTRONG Program or will be assigned to a wait-list control group. All measurements will be repeated at Dana-Farber or Yale after the 12-week exercise program or control period.

Official Title
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Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: LIVESTRONG


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cancer diagnosis excluding non-melanoma skin cancer Physically able to exercise Able to complete forms and understand instructions in English Agrees to be randomly assigned to either exercise or wait-list control group Willing and able to attend one of the LIVESTRONG at the YMCA programs for 12 weeks Willing and able to complete the baseline and 3-month clinic visits Exclusion Criteria: > 80 years of age < 18 years of age Recent (past 6 months) stroke/myocardial infarction or congestive heart failure/documented ejection fraction < 40% Plans to undergo a major surgical procedure in the next 6 months Presence of dementia or major psychiatric disease that would preclude participation in a group-based exercise program Pregnant women or women intending to become pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LIVESTRONG Program<br>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. | Behavioral: LIVESTRONG<br>* 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.<br>|
| No Intervention: Wait-List Control<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Physical Activity Level | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Fat Percentage | 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. | 3 months | 
| Change in Lean Body Mass | 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. | 3 months | 
| Change in Bone Mineral Density | 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. | 3 months | 
| Change in Body Mass Index (BMI) | 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. | 3 months | 
| Change in Blood Biomarkers | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Body Composition, Exercise, Survivorship