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

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ClinicalTrials.gov Identifier: NCT02112149
Recruitment Status : Completed
First Posted : April 11, 2014
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Yale University

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
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 Pre-specified Outcome Measures
 (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 Pre-specified Outcome Measures 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  ICMJE 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  ICMJE
  • 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  ICMJE 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE 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  ICMJE 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