C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)
- Conditions
- Cancer Survivors
- Interventions
- Behavioral: 12 week pilot intervention study.
- Registration Number
- NCT03750981
- Lead Sponsor
- Barbara Ann Karmanos Cancer Institute
- Brief Summary
This study will introduce cancer survivors to cross-training with the expectation that the program proposed will ultimately result in superior improvements in functional performance, body composition and quality of life compared with the current American Cancer Society (ACS) guidelines for cancer survivors.
- Detailed Description
A 12-week pilot intervention study introducing a high-intensity functional training program to 100 cancer survivors and evaluate the effects of this program on patient quality of life, functional capacity, and body composition. Response rates will be determined using various recruitment methods and estimate differences in response rates by patient characteristics including race, gender and age. Barriers to participation in the program in contacted patients who do not enroll as well as patients who enroll and do not complete the program will be described, as will participant satisfaction with enrolled participants who complete the program. The goal of this pilot study is to help refine the recruitment and program methods for a larger intervention study to test the superiority of a high-intensity interval functional training program compared with current American Cancer Society guidelines in improving functional capacity, body composition and patient reported quality of life.
Surveys will be completed by each participant weekly and physical assessments will be completed monthly.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- Aged 18 years or older at time of program recruitment
- Diagnosed with an invasive cancer
- Cleared from their physician to participate in the program (We assume that most patients will have completed treatment, however if a patient is currently under treatment, this should be their oncologist. If the patient is not currently undergoing treatment, this could be primary care physician or oncologist).
- Available transportation to and from the facility on session days
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description A 12-week pilot intervention study introducing a high-intensi 12 week pilot intervention study. -
- Primary Outcome Measures
Name Time Method Change in Motivation Baseline to 12 weeks Motivation to exercise will be collected via a survey
Program Adherence 12 weeks Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design.
Height Baseline Height will be collected in meters to use in the calculation of Body Mass Index
Enrollment rates Baseline Enrollment rates will be calculated among those who respond to notices about the study and adherence to the program among those who enroll and to describe reported barriers to participation among respondents who do not ultimately enroll
Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire Baseline to 12 weeks Quality of Life will be measured using the Functional Assessment of Cancer Therapy: General (FACT), developed by Dr. David Cella. The FACT-G is 27 items assessing physical, social/ family, emotional and functional well-being. The survey uses a five-point scale from 0 (not at all) to 4 (very much). Scoring the FACT-G is performed through a sum of item scores. Higher scores indicate a better health state.
Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program Baseline to 12 weeks Physical measures of cardiovascular strength will be assessed by a certified trainer. To assess cardiovascular strength maximum effort on a stationary bike will be recorded. Additionally, in the circuit, a maximum effort on a rowing machine will be recorded.
Change in Body Composition Baseline to 12 weeks Changes in resting metabolism value
Satisfaction with the Program 12 weeks Satisfaction with the program will be collected via a survey
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Barbara Ann Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States