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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Colorado, Denver

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Be an active participant in the BfitBwell Cancer Exercise Program

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

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: BfitBwell Participants

Trial outcomes

Primary outcomes

1

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?

Time frame
3 months
2

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.

Time frame
3 months

Secondary outcomes

1

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.

Time frame
3 months

Other outcomes

1

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.

Time frame
3 months

Sponsors and contacts

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University of Colorado, Denver

Lead sponsor

National Cancer Institute (NCI)

Collaborator