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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Survivors
• Intervention / Treatment: Behavioral: 12 week pilot intervention study.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer B Beebe-Dimmer, MPH, PhD.; Phone Number: (313) 578-4209; Email: dimmerj@karmanos.org
• Study Contact Backup: Name: Tara Baird, M.Ed.; Phone Number: (313) 578-4246; Email: bairdt@karmanos.org

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Barbara Ann Karmanos Cancer Institute
      • Contact: Tara Baird; Phone Number: 313-578-4246; Email: bairdt@karmanos.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A 12-week pilot intervention study introducing a high-intensi	Behavioral: 12 week pilot intervention study.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Barbara Ann Karmanos Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Anticipated): April 30, 2024
• Study Completion (Anticipated): April 30, 2024

Study Registration Dates

• First Submitted: November 15, 2018
• First Submitted That Met QC Criteria: November 20, 2018
• First Posted (Actual): November 23, 2018

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 18, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2018-091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No