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

Tracking Information
First Submitted Date ICMJE	April 9, 2014
First Posted Date ICMJE	April 11, 2014
Last Update Posted Date	July 13, 2016
Study Start Date ICMJE	February 2013
Actual Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 10, 2014)	Change in Physical Activity Level [ Time Frame: 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.
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT02112149 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 10, 2014)	Change in Body Fat Percentage [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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.; Change in Blood Biomarkers [ Time Frame: 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.
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE; (submitted: April 10, 2014)	Change in Walk Distance [ Time Frame: 12 weeks ]All participants will undergo a 6MWT at baseline and after the 12-week protocol period. Participants will wear tennis shoes and will walk indoors along a long, flat, straight, enclosed corridor, on a flat surface for 6 minutes. They will be instructed to walk continuously along an area at least 50 feet in length, back and forth, for 6 minutes.; Change in Quality of Life [ Time Frame: 12 weeks ]Quality of Life (QOL) will be measured using the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire (version 3) as well as the PROMISE Q. Breast cancer survivors will also complete the FACT-B-ES form that assesses endocrine-related symptoms specific to breast cancer. Additionally, fatigue will be assessed through the FACT-Fatigue Scale, which consists of 13 items designed to assess fatigue in terms of its intensity and interference with performing everyday functions.; Lymphedema Questionnaire [ Time Frame: 12 weeks ]Breast cancer survivors will complete a validated Norman Lymphedema Questionnaire. Previous methodologically strong studies have shown exercise, including upper body resistance/strength training, to decrease the risk of exacerbation of lymphedema as well as severity of lymphedema symptoms in breast cancer survivors randomized to a twice-weekly year long strength training program compared with breast cancer survivors randomized to control. Given these findings, breast cancer survivors with lymphedema will not be excluded from participation in the study. However, MD consent to exercise will be obtained from her oncologist.; Change in Breast Cancer Prevention Trial Symptom Checklist [ Time Frame: 3 months ]The Breast Cancer Prevention Trial Symptom Checklist Short Form is a symptom checklist that will be completed by all study participants at baseline and 3-months to assess side effects/symptoms related to cancer surgery and treatment and how exercise may improve or prevent some of these symptoms. Symptoms such as lymphedema, neuropathy, and arthralgias will be assessed.
Original Other Outcome Measures ICMJE	Same as current
Descriptive Information
Brief Title ICMJE	Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
Official Title ICMJE	Effect of the LIVESTRONG at the YMCA Exercise Program on Cancer Related Outcomes in Cancer Survivors
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 Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Behavioral: LIVESTRONG; 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.
Study Arms	Experimental: LIVESTRONG Program 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. Intervention: Behavioral: LIVESTRONG; No Intervention: Wait-List Control 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Estimated Enrollment ICMJE; (submitted: April 10, 2014)	200
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	December 2015
Actual Primary Completion Date	December 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 80 Years (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT02112149
Other Study ID Numbers ICMJE	1301011291
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Yale University
Study Sponsor ICMJE	Yale University
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Melinda L Irwin, PhD, MPH Yale University Principal Investigator: Jennifer A Ligibel, MD Dana-Farber Cancer Institute
PRS Account	Yale University
Verification Date	July 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP