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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Remission

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Jared Scorsone; Phone Number: 303-724-1264; Email: JARED.SCORSONE@CUANSCHUTZ.EDU

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado Cancer Center
      • Contact: Jared Scorsone; Phone Number: 303-724-1264; Email: JARED.SCORSONE@CUANSCHUTZ.EDU
      • Principal Investigator: Ryan Marker, PhD, PT

Participation Criteria

Eligibility Criteria

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

• 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.

Description

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:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physical assessment measures from BfitBwell Program	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.	3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response Rate to EMA assessments	Measures of fatigue are collected electronically. Tools utilized to collect these outcomes: REDCap and the LifeData smartphone application.; REDCap: REDCap is a secure, university supported and approved data collection tool. Links to complete the standardized questionnaires of fatigue (FACIT-Fatigue and MFI) will be emailed to participants with regular reminder emails sent daily until completed.; LifeData: LifeData is a secure research platform used by previous research studies involving EMA (https://www.lifedatacorp.com/customer-publications/). The application will send a smartphone notification to collect data at random timepoints in predefined windows, and allow participants to self-initiate data entry. Participants will not enter any identifying information and will instead be assigned a de-identified research IDd. Linking documentation of participant to this ID will be stored solely on university servers. LifeData will be utilized to collect the EMA assessments of fatigue.	3 months

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ryan Marker, PhD, PT, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: September 28, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Estimated): July 8, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 21-3391.cc; P30CA046934 (U.S. NIH Grant/Contract)

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
• product manufactured in and exported from the U.S.: No