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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: LIVESTRONG

• Registration Number: NCT02112149
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2014-04-09
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-11
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-11
• Last Update Posted: 2016-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LIVESTRONG Program	LIVESTRONG	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.

Primary Outcome Measures

Name	Time	Method
Change in Physical Activity Level	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.

Secondary Outcome Measures

Name	Time	Method
Change in Blood Biomarkers	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 Body Fat Percentage	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	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	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)	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.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States