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

Cancer Remission Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05073848
• Other study ID #: 21-3391.cc
• Secondary ID: P30CA046934
• Status: Recruiting
• Start date: October 20, 2021
• Est. completion date: June 1, 2025

Study information

• Verified date: July 2023
• Source: University of Colorado, Denver
• Contact: Jared Scorsone
• Phone: 303-724-1264
• Email: JARED.SCORSONE[@]CUANSCHUTZ.EDU
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Remission
• Fatigue

Locations

Country	Name	City	State
United States	University of Colorado Cancer Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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