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NCT Number: NCT05073848

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.

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Key information

Conditions

Cancer Remission

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Jared Scorsone

CONTACT

[email protected]

303-724-1264

Ryan Marker, PhD, PT

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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?

  2. 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.

Secondary outcomes

  1. Physical assessment measures from BfitBwell Program

    Time frame: 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.

Other outcomes

  1. Response Rate to EMA assessments

    Time frame: 3 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jared Scorsone

CONTACT

[email protected]

303-724-1264

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2028
First posted
Oct 12, 2021
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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