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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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?
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.
Secondary outcomes
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.
Other outcomes
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.
Sponsors and contacts
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University of Colorado, Denver
Lead sponsor
National Cancer Institute (NCI)
Collaborator