C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Pilot Study of Cross-Training in Cancer Survivors

Conditions
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Cancer Survivors

Intervention / Treatment
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* Behavioral: 12 week pilot intervention study.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: A 12-week pilot intervention study introducing a high-intensi<br> | Behavioral: 12 week pilot intervention study.<br>* Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment rates | 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 | Baseline | 
| Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program | Physical measures of strength will be assessed by a certified trainer. To assess strength improvements deadlifts (lifting weights from floor to waist) will be performed in 10 lb. increments. A circuit will also be done with strength measures including sit ups and push ups. | Baseline to 12 weeks | 
| Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program | Physical measures of flexibility will be assessed by a certified trainer. To assess flexibility sit ups, squats and push up level (floor, knees, on an elevated bar, etc) will be recorded. | Baseline to 12 weeks | 
| Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program | 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. | Baseline to 12 weeks | 
| Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire | 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. | Baseline to 12 weeks | 
| Change in Body Composition | Changes in weight in kg | Baseline to 12 weeks | 
| Change in Body Composition | Changes in body fat percentage | Baseline to 12 weeks | 
| Change in Body Composition | Changes in visceral fat percentage | Baseline to 12 weeks | 
| Change in Body Composition | Changes in muscle mass percentage | Baseline to 12 weeks | 
| Change in Body Composition | Changes in body mass index (BMI) - Weight and height will be combined to report BMI in kg/ m2 | Baseline to 12 weeks | 
| Change in Body Composition | Changes in resting metabolism value | Baseline to 12 weeks | 
| Change in Motivation | Motivation to exercise will be collected via a survey | Baseline to 12 weeks | 
| Satisfaction with the Program | Satisfaction with the program will be collected via a survey | 12 weeks | 
| Program Adherence | Program adherence will be calculated based on how many sessions each participant attended in the 13 week program, 36 session design. | 12 weeks | 
| Height | Height will be collected in meters to use in the calculation of Body Mass Index | Baseline |