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

NCT05073848 | Recruiting DMC

• 2 other identifiers: 21-3391.ccP30CA046934
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Remission

Outcome Measures

Primary Outcomes (2)

• 10-point Fatigue Scale, Day

  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?

  3 months

• Physical Activity measure by Actigraph device

  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.

  3 months

Secondary Outcomes (1)

• Physical assessment measures from BfitBwell Program

  3 months

Other Outcomes (1)

• Response Rate to EMA assessments

  3 months

Study Arms (1)

BfitBwell Participants

Individuals in the BfitBwell Cancer Exercise Program complete a FACIT-Fatigue questionnaire at their baseline assessment. This will be screened for all incoming BfitBwell participants and those meeting the inclusion criteria of a score of 48 or less will be approached for interest in participating. The primary research activities beyond recruitment, screening, and informed consent are the collection of EMA fatigue assessments via smartphone application and PA assessment via actigraphy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will enroll 50-150 cancer survivors participating in the BfitBwell Cancer Exercise Program. As this is a non-invasive, exploratory observational investigation, there are minimal inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

RECRUITING

Study Officials

• Ryan Marker, PhD, PT

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jared Scorsone

CONTACT

303-724-1264; JARED.SCORSONE@CUANSCHUTZ.EDU

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: October 12, 2021
• Study Start: October 20, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)