Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
300 participants
INTERVENTIONAL
2026-01-14
2030-03-01
Brief Summary
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* Aim 1: Examine the effect of a group-based videoconference physical activity (PA) intervention on moderate to vigorous physical activity \[MVPA\] (i.e., aerobic and resistance exercise).
* Aim 2: Examine the effect of the intervention on additional health-related outcomes including physical fitness (i.e., aerobic endurance, muscular strength), and quality of life at both timepoints.
* Aim 3: Explore potential mediators and moderators of intervention effects. We will examine mediators (e.g., self-efficacy, outcome expectations, group cohesion) and moderators (e.g., age, cancer stage, neighborhood walkability) of the intervention on MVPA.
* Exploratory Aim: Determine whether a group-based videoconference PA intervention reduces loneliness among cancer survivors.
Researchers will randomize participants into one of two guided exercise groups that are 12-weeks long in duration. Participants will be asked to complete online fitness assessments and surveys as well as wear a physical activity monitor device and watch a few times throughout the study. The whole study is 9-months long in duration with a 6-month free-living period where no study activities will take place.
Detailed Description
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Supervised interventions that utilize behavior change techniques like goal setting, social support, self-monitoring, action planning, and instruction on how to perform behavior, are most successful in increasing PA among cancer survivors. However, delivering these interventions face-to-face can be resource intensive, and present a barrier to cancer survivors in terms of access (e.g., no programs available nearby, and recently, due to social distancing requirements of the COVID-19 pandemic).
Web, text messaging, and other remote or distance-based PA interventions for cancer survivors demonstrate promise however they exhibit a smaller magnitude of effect on MVPA and physical and psychosocial outcomes than those that are delivered face-to-face. Key factors for this diminished effect size may be lower adherence/compliance due to lack of supervision, and fewer opportunities available for social interaction and support. Cancer survivors acknowledge the importance of peer support for PA, report that one of the quintessential facilitators for engaging in PA is the social benefit and describe camaraderie and the opportunity to be surrounded by others with a shared experience as motivating for being physically active.
The majority of remote or distance-based PA interventions for cancer survivors have been delivered asynchronously (i.e., occurs through online channels without real-time interaction), which eliminates direct supervision from a qualified exercise professional, and presents a challenge for tangible social connections. Conversely, virtually supervised PA interventions (i.e., using videoconferencing) are delivered synchronously, offering the opportunity for real-time supervision and social interaction, while retaining the scalability and reach advantages of remote delivery modalities. However, to date, there have been no large-scale, randomized controlled trials testing the efficacy of a group-based videoconference intervention to increase MVPA in cancer survivors. Videoconferencing can expand the reach of supervised, group-based interventions while potentially enhancing the effects of asynchronous distance-delivered modalities on MVPA, physical, and psychosocial outcomes. Thus, with the substantial, beneficial effects of PA for cancer survivors and the scalability potential of videoconference delivery, findings from this study stand to have high impact not only on the field of PA/exercise for cancer survivorship but can also inform similar interventions and programs for other chronic disease populations.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Intervention (Virtually Supervised Exercise Class)
Live, group-based exercise classes will be delivered 2x per week on Zoom for 12-weeks along with a total of 5 behavior change discussion sessions.
Virtually Supervised Exercise Sessions
The 12-week intervention will consist of supervised exercise sessions twice per week, and PA behavior change discussion sessions twice per month (bi-weekly) throughout the study for a total of five sessions (Week 2, 4, 6, 8 and 10). Exercise and PA behavior change discussion sessions will be informed by social cognitive theory, operationalize several BCT's, and include group dynamics-based strategies to enhance group cohesion. Exercise sessions will take place twice per week, lasting approximately one hour.
Comparator (Asynchronous Exercise Sessions)
Participants will watch pre-recorded exercise and discussion videos for 12-weeks.
Asynchronous Group
The comparator will be an "unsupported intervention",128 which will use the same technology and provide the same content as the intervention but subtract the human components. Participants in the control group will receive access to pre-recorded (i.e., asynchronous) videos of the exercise and discussion sessions. The exercise videos will follow the same format as those in the intervention (i.e., instructor led, circuit-style aerobic and resistance exercises). Discussion sessions will operationalize the same BCT's using PowerPoint slides. Comparator arm participants will receive instructions on how to access these videos via a unique participant login to a secure website, Canvas, the same recommendations to achieve PA guidelines, and the same home-based exercise equipment (along with instructions for use).
Interventions
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Virtually Supervised Exercise Sessions
The 12-week intervention will consist of supervised exercise sessions twice per week, and PA behavior change discussion sessions twice per month (bi-weekly) throughout the study for a total of five sessions (Week 2, 4, 6, 8 and 10). Exercise and PA behavior change discussion sessions will be informed by social cognitive theory, operationalize several BCT's, and include group dynamics-based strategies to enhance group cohesion. Exercise sessions will take place twice per week, lasting approximately one hour.
Asynchronous Group
The comparator will be an "unsupported intervention",128 which will use the same technology and provide the same content as the intervention but subtract the human components. Participants in the control group will receive access to pre-recorded (i.e., asynchronous) videos of the exercise and discussion sessions. The exercise videos will follow the same format as those in the intervention (i.e., instructor led, circuit-style aerobic and resistance exercises). Discussion sessions will operationalize the same BCT's using PowerPoint slides. Comparator arm participants will receive instructions on how to access these videos via a unique participant login to a secure website, Canvas, the same recommendations to achieve PA guidelines, and the same home-based exercise equipment (along with instructions for use).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with any type of cancer within the last 5 years
* Completed primary or adjuvant treatment (i.e., chemotherapy, radiation therapy, surgery) with no planned treatment within the next nine months. This does not include long-term or chronic therapies such as anti-hormone or targeted therapies (e.g., aromatase inhibitor, androgen deprivation therapy, immunotherapies)
Exclusion Criteria
* Known contraindications for non-medically supervised moderate or greater intensity exercise (e.g., uncontrolled hypertension, inability to walk without an assistive device)
* Current or planned participation in another structured program or intervention intended to encourage participation in exercise or physical activity.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Colorado State University
OTHER
Responsible Party
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Heather Leach
PhD
Principal Investigators
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Heather J Leach, PhD
Role: PRINCIPAL_INVESTIGATOR
Colorado State University
Central Contacts
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Other Identifiers
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6002
Identifier Type: -
Identifier Source: org_study_id