Clinical trial NCT02112149: Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
Official title: Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Body Composition
Exercise
Survivorship
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-04-11
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Physical Activity Level
timeFrame: 3 months
Secondary outcomes:
measure: Change in Body Fat Percentage
timeFrame: 3 months
measure: Change in Lean Body Mass
timeFrame: 3 months
measure: Change in Bone Mineral Density
timeFrame: 3 months
measure: Change in Body Mass Index (BMI)
timeFrame: 3 months
measure: Change in Blood Biomarkers
timeFrame: 12 weeks
Other outcomes:
measure: Change in Walk Distance
timeFrame: 12 weeks
measure: Change in Quality of Life
timeFrame: 12 weeks
measure: Lymphedema Questionnaire
timeFrame: 12 weeks
measure: Change in Breast Cancer Prevention Trial Symptom Checklist
timeFrame: 3 months
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Yale University
name: Melinda L Irwin, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Jennifer A Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
References: