Clinical trial NCT03750981: C.A.P.A.B.L.E. (Cross-Training and Physical Activity: A Better Life Experience Study)
Official title: Does High-Intensity Functional Training Improve Patient Movement and Quality of Life? A Pilot Study of Cross-Training in Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Survivors
Lead sponsor: Barbara Ann Karmanos Cancer Institute
Sponsor class: OTHER
First posted: 2018-11-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Enrollment rates
timeFrame: Baseline
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
timeFrame: Baseline to 12 weeks
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
timeFrame: Baseline to 12 weeks
measure: Change in functional performance and variability in functional performance among adult cancer survivors enrolled in a high-intensity functional training program
timeFrame: Baseline to 12 weeks
measure: Change in self-reported health-related quality of life (HRQOL) and variability using the FACT questionnaire
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Body Composition
timeFrame: Baseline to 12 weeks
measure: Change in Motivation
timeFrame: Baseline to 12 weeks
measure: Satisfaction with the Program
timeFrame: 12 weeks
measure: Program Adherence
timeFrame: 12 weeks
measure: Height
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
Study officials:
affiliation: Barbara Ann Karmanos Cancer Institute
name: Jennifer Beebe-Dimmer, MPH, PhD.
role: PRINCIPAL_INVESTIGATOR
References: