Relationships Between Physical Activity and Different Measures of Fatigue in Cancer Survivors

Recruiting

• Conditions: Cancer Remission

• Registration Number: NCT05073848
• Lead Sponsor: University of Colorado, Denver

Brief Summary

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.

Detailed Description

This is an investigation of possible relationships between daily physical activity (PA) and different measurements of fatigue in cancer survivors participating in a cancer exercise program. Results will inform exercise prescription and timing to best reduce fatigue, as well as methodology for measuring fatigue. Participants will answer several daily questions on fatigue using a smartphone application during the 3 month exercise program and wear a PA monitor for 10 days during the first month and last month of the program.

Study Timeline

• Study First Submitted: 2021-07-22
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-10-12
• Study Start: 2021-10-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-24
• Primary Completion: 2025-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Be an active participant in the BfitBwell Cancer Exercise Program
• Criteria for this program include:
• Adult (>= 18 years old)
• Being a patient seen at the University of Colorado Cancer Center
• Currently receiving cancer therapy or be within 6 months of completing cancer therapy
• Have a signed physician clearance form to participate in an exercise program
• Have a smartphone (necessary for the EMA assessments)
• A score of 48 or less on the FACIT-Fatigue (completed during the initial BfitBwell Program assessment)
• The minimally important difference of the FACIT-Fatigue is 3 points, suggesting that a score of at most 48 indicates the presence of CRF and allows for meaningful change in both directions.

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical Activity measure by Actigraph device	3 months	PA will be monitored using commonly used, non-invasive Actigraph devices (Actigraph GT3XP). Data will be collected utilizing methodology similar to that of the National Health and Nutrition Examination Survey (NHANES), in cancer survivors. The collected accelerometry data will be downloaded and analyzed in ActiLife software, calculation the average time spent in moderate-to-vigorous (MVPA) at each assessment period using standard algorithms and cut-points.
10-point Fatigue Scale, Day	3 months	Severity of fatigue experienced over the course of the day, ranked 0-10. How would you rate your fatigue, over the last day, on a scale of 0-10, with 0 being no fatigue and 10 being the worst possible fatigue?

Secondary Outcome Measures

Name	Time	Method
Physical assessment measures from BfitBwell Program	3 months	As all participants are recruited from active members of BfitBwell Cancer Exercise Program, additional data will be extracted from program documents which are regularly administered and collected by the BfitBwell Program. Administration/collection will not change for study participants. Physical assessment measures are obtained from a physical assessment and electronic questionnaire.

Trial Locations

Locations (1)

University of Colorado Cancer Center; 🇺🇸 Aurora, Colorado, United States