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Clinical Trials/NCT04806139
NCT04806139
Completed
N/A

Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors

University of Vermont1 site in 1 country39 target enrollmentApril 7, 2021
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Vermont
Enrollment
39
Locations
1
Primary Endpoint
Fatigue
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The proposed pilot study will test the acceptability and feasibility of a sixteen-week, two-arm randomized control physical activity intervention in older cancer survivors. The Survivors Taking Action with Remote exercise Training (JumpSTART) program is intended for cancer survivors (Stage I-III) age 60 or older, living in rural areas. The goal of this intervention is to increase physical activity opportunities for cancer survivors who are geographically isolated by offering exercise classes (EnhanceFitness) online. The real-time instruction of group-based classes helps older adults to exercise by establishing relationships, fostering social support and receiving corrective and supportive feedback from instructors that enhance self-efficacy for exercise.

Registry
clinicaltrials.gov
Start Date
April 7, 2021
End Date
October 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nancy Gell

Associate Professor

University of Vermont

Eligibility Criteria

Inclusion Criteria

  • Rural residence by self-report and confirmed with Rural-Urban Commuting Area Codes
  • Stage I-III cancer history
  • Completion of adjuvant chemotherapy, radiation therapy, or surgery for cancer diagnosis
  • Age 60 years or older
  • Ability to walk for exercise
  • Self-reported minimal or inconsistent participation in strengthening exercise and physical activity (\< 150 minutes/week moderate-to-vigorous physical activity; confirmed with baseline accelerometer measures)
  • Clearance for exercise based on a modified, combined Screening Cancer Survivors for Unsupervised Moderate-to-Vigorous Intensity Exercise and the Screening for Physical Activity Readiness Questionnaire (PAR-Q) or physician approval as needed based on the pre-screening/PAR-Q responses

Exclusion Criteria

  • Not available for the study duration
  • Unable to communicate by phone
  • Unable to attend exercise class at schedule time (M,W,F, time TBD)
  • Currently enrolled in another exercise program
  • Unable to communicate in English

Outcomes

Primary Outcomes

Fatigue

Time Frame: 4 months

The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on fatigue. Scale range is 1-5 (Not at all, Very much). Higher scores indicate worse fatigue

Physical Activity (PA) and Sedentary Time Assessment

Time Frame: 4 months

Physical activity and sedentary time will be assessed using the activPAL accelerometer. Participants will wear the device for seven (7) days during each measurement period. Overall PA levels will be assessed via daily step counts and minutes of moderate-to-vigorous physical activity and will be summed across the week. Accelerometer data will also include sedentary time and light physical activity time.

Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a

Time Frame: 4 months

Physical function will be assessed with the PROMIS Physical Function short form. This measure has 10 items and been validated for use in multiple populations including cancer survivors and people with multiple chronic conditions. Scale range is 1-5 (not at all, very much) with higher scores indicating worse physical function.

Sleep disturbance

Time Frame: 4 months

The Patient Reported Outcome Measurement System (PROMIS)-29 will be collected which includes 4 items on sleep disturbance. Scale range is 1-5 (Never, Always). Higher scores indicate worse sleep disturbance.

Secondary Outcomes

  • 30 second-sit-to-stand test(4 months)
  • Four-stage balance test(4 months)
  • Technology Use and Acceptance(4 months)
  • Five time sit-to-stand test(4 months)
  • Adapted Technology Acceptance Model Scale(4 months)
  • Duke Activity Status Index(4 months)

Study Sites (1)

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