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

Yale University

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Behavioral: LIVESTRONG

Study type: Interventional

Funder types: Other

Identifiers

NCT02112149

1301011291

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

LIVESTRONG Program

Experimental group

Description:

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.

Treatment:

Behavioral: LIVESTRONG

Wait-List Control

No Intervention group

Description:

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.