Clinical trial NCT04806139: Survivors Taking Action With Remote Exercise Training
Official title: Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: physical activity
rural
cancer
older adults
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 39
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention will be offered to two groups (goal sample size of 15 participants in each group, with additional recruiting to account for attrition). The second Remote Enhance Fitness group will begin following the completion of the first group.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a
timeFrame: 4 months
measure: Fatigue
timeFrame: 4 months
measure: Sleep disturbance
timeFrame: 4 months
measure: Physical Activity (PA) and Sedentary Time Assessment
timeFrame: 4 months
Secondary outcomes:
measure: Five time sit-to-stand test
timeFrame: 4 months
measure: 30 second-sit-to-stand test
timeFrame: 4 months
measure: Four-stage balance test
timeFrame: 4 months
measure: Duke Activity Status Index
timeFrame: 4 months
measure: Technology Use and Acceptance
timeFrame: 4 months
measure: Adapted Technology Acceptance Model Scale
timeFrame: 4 months
Other outcomes:
Locations:
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
Study officials:
affiliation: University of Vermont
name: Nancy Gell
role: PRINCIPAL_INVESTIGATOR
References: