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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA296965-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Virtually Supervised Exercise Class) | Experimental | 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. |
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| Comparator (Asynchronous Exercise Sessions) | Active Comparator | Participants will watch pre-recorded exercise and discussion videos for 12-weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtually Supervised Exercise Sessions | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in accelerometer measured moderate to vigorous physical activity from baseline to 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 | Assessed by Godin Leisure Time Exercise Questionnaire (GLTEQ) | Assessed at baseline, 3 and 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life will be assessed by a quantitative self-report questionnaire | 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. | Assessed at baseline and 3 and 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Heather J Leach, PhD | Contact | (970) 491-8951 | heather.leach@colostate.edu | |
| Elena M Lancioni, MPH | Contact | (970) 491-4653 | elena.lancioni@colostate.edu |
| Name | Affiliation | Role |
|---|---|---|
| Heather J Leach, PhD | Colorado State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Performance Clinical Research Lab | Recruiting | Fort Collins | Colorado | 80523 | United States |
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| Label | URL |
|---|---|
| Study website where participants can learn more about the study and register interest | View source |
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This study is a two-arm randomized controlled trial. Following the NIH Stage Model for Behavioral Intervention Development, we propose a stage II intervention, with the goal of traditional efficacy testing consisting of experimental testing in research settings, with research-based providers
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| Asynchronous Group | Behavioral | 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). |
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| Physical fitness assessed by sit-to-stand and 2-minute step test | 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 |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003110 | Colonic Neoplasms |
| D001943 | Breast Neoplasms |
| D008223 | Lymphoma |
| D009101 | Multiple Myeloma |
| D009043 | Motor Activity |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D009370 | Neoplasms by Histologic Type |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |
| D001519 | Behavior |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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