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Clinical Trials/NCT05073848
NCT05073848
Recruiting
Not Applicable

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

University of Colorado, Denver1 site in 1 country150 target enrollmentOctober 20, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cancer Remission
Sponsor
University of Colorado, Denver
Enrollment
150
Locations
1
Primary Endpoint
Physical Activity measure by Actigraph device
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 20, 2021
End Date
June 1, 2026
Last Updated
9 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Physical Activity measure by Actigraph device

Time Frame: 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

Time Frame: 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 Outcomes

  • Physical assessment measures from BfitBwell Program(3 months)

Study Sites (1)

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