Survivors Taking Action With Remote Exercise Training

Cancer Clinical Trial

— JumpSTART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04806139
• Other study ID #: UVMCC 2100/CHRMS 00001375
• Status: Completed
• Phase: N/A
• Start date: April 7, 2021
• Est. completion date: October 31, 2022

Study information

• Verified date: October 2022
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: October 31, 2022
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Behavioral:
• Remote Enhance Fitness
The Remote Enhance Fitness Intervention will include live-streamed exercise classes (1-hour long, 3 days per week, 16 weeks). Certified Enhanced Fitness trainers will lead the exercise classes per Enhance Fitness guidelines, including modifications and gradual progression. During weeks 8-12 participants will have the option to wear a Fitbit during classes for up to 6 class session (2 weeks) for collection of heart rate, steps, and physical activity intensity along with ratings of perceived exertion (RPE) during exercise classes.

Locations

Country	Name	City	State
United States	University of Vermont	Burlington	Vermont

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a	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.	4 months
Primary	Fatigue	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	4 months
Primary	Sleep disturbance	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.	4 months
Primary	Physical Activity (PA) and Sedentary Time Assessment	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.	4 months
Secondary	Five time sit-to-stand test	Measure of strength (power): Score is in seconds with higher scores indicating worse physical performance. This assessment will be conducted remotely over video-conference.	4 months
Secondary	30 second-sit-to-stand test	Strength (endurance) will be assessed using the validated 30 second sit-to-stand test: Score is in seconds with higher score indicating better physical performance. This assessment will be conducted remotely over video-conference.	4 months
Secondary	Four-stage balance test	Measure of balance: Score is in seconds with completion of all 4 stages indicated better balance. This assessment will be conducted remotely over video-conference.	4 months
Secondary	Duke Activity Status Index	Status will be assessed using a 12-item questionnaire that assesses the ability to do self-care, housework, sports, and other activities. Response options are "Yes" or "No" for each of the 12 items. Higher scores indicate higher functional fitness levels.	4 months
Secondary	Technology Use and Acceptance	The 14-item short version of the Senior Technology Acceptance Model (STAM) has demonstrated reliability and validity to measure technology-related attitudinal beliefs, control beliefs, and anxiety in older adults. Scale is 1-10 with higher scores indicating higher technology use and acceptance.	4 months
Secondary	Adapted Technology Acceptance Model Scale	The 10-item adapted version of the Technology Acceptance Model (TAM) has demonstrated reliability and validity to measure technology-related ease of use, usefulness, financial cost, and intention to use. Scale range is 1-7 (Strongly disagree to Strongly agree) and higher scores indicate better usability, usefulness, and more intention to use.	4 months