- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07290309
Survivors Uniting for Remote Guided Exercise (SURGE)
Efficacy of a Group-based Videoconference Intervention to Increase Physical Activity in Cancer Survivors
The goal of this research study is to look at how live, online group exercise compares to recorded videos for helping increase physical activity levels, improve physical fitness and quality of life, and reduce loneliness among those living with and beyond cancer. The following aims have been established for this study:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
For cancer survivors, moderate to vigorous intensity physical activity (MVPA) is associated with up to 50% reductions in cancer-specific and all-cause mortality. Previous studies also consistently demonstrate that MVPA improves cancer survivor's' physical function and quality of life. However, recent estimates suggest that only 14.2% of cancer survivors engage in the amount of MVPA considered necessary to achieve these health benefits, indicating a need for effective and wide-reaching interventions to increase MVPA.
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather J Leach, PhD
- Phone Number: (970) 491-8951
- Email: heather.leach@colostate.edu
Study Contact Backup
- Name: Elena M Lancioni, MPH
- Email: elena.lancioni@colostate.edu
Study Locations
-
-
Colorado
-
Fort Collins, Colorado, United States, 80523
- Recruiting
- Human Performance Clinical Research Lab
-
Contact:
- Elena Lancioni
- Phone Number: 970-491-4653
- Email: patplab@colostate.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak/read English,
- 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:
- Existing participation in ≥150 minutes per week of at least moderate intensity aerobic exercise
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
|
Active Comparator: Comparator (Asynchronous Exercise Sessions)
Participants will watch pre-recorded exercise and discussion videos for 12-weeks.
|
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in accelerometer measured moderate to vigorous physical activity from baseline to 3- and 6-month follow-up
Time Frame: Assessed at baseline, 3-and 6-month follow-up
|
MVPA will be compared between the intervention and comparator arm from baseline to post-intervention (primary endpoint) and six-month follow-up.
|
Assessed at baseline, 3-and 6-month follow-up
|
|
Change in self-reported moderate-to-vigorous intensity physical activity from baseline to 3 and 6 month follow-up
Time Frame: Assessed at baseline, 3 and 6-month follow-up
|
Assessed by Godin Leisure Time Exercise Questionnaire (GLTEQ)
|
Assessed at baseline, 3 and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life will be assessed by a quantitative self-report questionnaire
Time Frame: Assessed at baseline and 3 and 6 month follow-up
|
A quality of life survey will be sent at three time points throughout the study: Enrollment, 3-month follow-up, & 6-month follow-up.
QOL is assessed on a scale of (1-5) and has different subscales wherein some subscales have a reverse scoring system.
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Assessed at baseline and 3 and 6 month follow-up
|
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Physical fitness assessed by sit-to-stand and 2-minute step test
Time Frame: Assessed at baseline and 3 and 6 month follow-up
|
Participants will complete a total of three study assessments at the following timepoints: Enrollment, 3 -month follow-up, & 6-month follow-up from program completion
|
Assessed at baseline and 3 and 6 month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Heather J Leach, PhD, Colorado State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Vascular Diseases
- Cardiovascular Diseases
- Urogenital Neoplasms
- Neoplasms by Site
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Intestinal Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Colorectal Neoplasms
- Intestinal Neoplasms
- Genital Diseases, Female
- Hematologic Diseases
- Endocrine Gland Neoplasms
- Colonic Diseases
- Ovarian Diseases
- Adnexal Diseases
- Genital Neoplasms, Female
- Gonadal Disorders
- Skin Diseases
- Breast Diseases
- Lymphatic Diseases
- Lymphoproliferative Disorders
- Immunoproliferative Disorders
- Neoplasms, Plasma Cell
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Hemorrhagic Disorders
- Behavior
- Skin and Connective Tissue Diseases
- Hemic and Lymphatic Diseases
- Neoplasms
- Colonic Neoplasms
- Ovarian Neoplasms
- Breast Neoplasms
- Lymphoma
- Multiple Myeloma
- Motor Activity
Other Study ID Numbers
- 6002
- 1R01CA296965-01 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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