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

NCT02112149 | Completed Phase 3 DMC

• 1 other identifier: 1301011291
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Body Composition; Exercise; Survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change in Body Fat Percentage

  3 months

• Change in Lean Body Mass

  3 months

• Change in Bone Mineral Density

  3 months

• Change in Body Mass Index (BMI)

  3 months

• Change in Blood Biomarkers

  12 weeks

Other Outcomes (4)

• Change in Walk Distance

  12 weeks

• Change in Quality of Life

  12 weeks

• Lymphedema Questionnaire

  12 weeks

Study Arms (2)

LIVESTRONG Program

EXPERIMENTAL

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

Wait-List Control

NO INTERVENTION

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.

Interventions

LIVESTRONG BEHAVIORAL

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.

LIVESTRONG Program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \> 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06519, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Study Officials

• Melinda L Irwin, PhD, MPH

  Yale University

  PRINCIPAL INVESTIGATOR

• Jennifer A Ligibel, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: April 11, 2014
• Study Start: February 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: July 13, 2016

Record last verified: 2016-07

Locations

US (2)