CancerJumpSTARTNCT04806139
Survivors Taking Action With Remote Exercise Training
A study testing Remote Enhance Fitness in people with Cancer, run by University of Vermont at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Remote Enhance Fitness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors
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.
- Conditions
- Cancer
- Being tested
- Remote Enhance Fitness
- Keywords
- physical activity, rural, cancer, older adults
- Medical subject headings
- Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote Enhance FitnessBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Remote Enhance Fitness | Experimental | Participants assigned to the intervention group will participated in a 16-week remote exercise intervention. Following a home/space environment and technology needs assessment, participants will attend a one-on-one orientation and practice class with a research assistant. Participants will join a live-streamed, instructor-led group Enhance Fitness exercise session for 1-hour, 3 days/week for 4 months (16-weeks). Receives: Behavioral: Remote Enhance Fitness |
| Waitlist Control | No intervention | Participants randomized to the waitlist control group will be offered the opportunity to participate in the Remote Enhance Fitness class after study measures are completed. Cuff weights will be provided along with technical orientation, support, and equipment as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
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
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Secondary outcomes (6)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start7 Apr 2021
- Primary completion14 Oct 2022
- Study completion31 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Gell, University of Vermont
- Investigators
- Nancy Gell, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04806139
- Sponsor's protocol ID
- UVMCC 2100/CHRMS 00001375
- Acronym
- JumpSTART
- Status last verified
- Oct 2022
- First submitted
- 8 Mar 2021
- Last updated
- 1 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translation of an Evidence-based Exercise Program for Remote Delivery to Rural, Older Cancer Survivors
- ClinicalTrials.gov ID
- NCT04806139
- Acronym / sponsor ID
- JumpSTART / UVMCC 2100/CHRMS 00001375
- Conditions
- Cancer
- Keywords
- physical activity, rural, cancer, older adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 19 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Remote Enhance Fitness | Experimental | Behavioral: Remote Enhance FitnessParticipants assigned to the intervention group will participated in a 16-week remote exercise intervention. Following a home/space environment and technology needs assessment, participants will attend a one-on-one orientation and practice class with a research assistant. Participants will join a live-streamed, instructor-led group Enhance Fitness exercise session for 1-hour, 3 days/week for 4 months (16-weeks). |
| Waitlist Control | No intervention | –Participants randomized to the waitlist control group will be offered the opportunity to participate in the Remote Enhance Fitness class after study measures are completed. Cuff weights will be provided along with technical orientation, support, and equipment as needed. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote Enhance FitnessThe 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. | Behavioural | Intervention Group - Remote Enhance Fitness |
Primary outcome
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.
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
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.
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.
6 secondary outcomes
Five time sit-to-stand test
Time frame: 4 months
30 second-sit-to-stand test
Time frame: 4 months
Four-stage balance test
Time frame: 4 months
Duke Activity Status Index
Time frame: 4 months
Technology Use and Acceptance
Time frame: 4 months
Adapted Technology Acceptance Model Scale
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Gell principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote Enhance Fitness in people with Cancer, run by University of Vermont at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Reported Outcome Measurement System (PROMIS)-Physical Function10a (time frame: 4 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2022.