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Completed

NCT Number: NCT04806139

Survivors Taking Action With Remote Exercise Training

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.

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Key information

Conditions

Cancer Behavior Motor Activity Neoplasms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05405, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote Enhance Fitness

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Secondary outcomes

  1. Five time sit-to-stand test

    Time frame: 4 months

    Measure of strength (power): Score is in seconds with higher scores indicating worse physical performance. This assessment will be conducted remotely over video-conference.

  2. 30 second-sit-to-stand test

    Time frame: 4 months

    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.

  3. Four-stage balance test

    Time frame: 4 months

    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. Duke Activity Status Index

    Time frame: 4 months

    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.

  5. Technology Use and Acceptance

    Time frame: 4 months

    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.

  6. Adapted Technology Acceptance Model Scale

    Time frame: 4 months

    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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

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

Acronym: JumpSTART

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 19, 2021
Registry last updated
Nov 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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