Survivors Uniting for Remote Guided Exercise

Official title

Efficacy of a Group-based Videoconference Intervention to Increase Physical Activity in Cancer Survivors

Overview

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.

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.

Interventions

• Behavioral 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 approximate
• Behavioral 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 operational

Primary outcome measures

• 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]
• 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]

Secondary outcome measures (2)

• Quality of life will be assessed by a quantitative self-report questionnaire [Time frame: Assessed at baseline and 3 and 6 month follow-up]
• Physical fitness assessed by sit-to-stand and 2-minute step test [Time frame: Assessed at baseline and 3 and 6 month follow-up]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• Human Performance Clinical Research Lab — Fort Collins

Identifiers

NCT: NCT07290309 · 6002 · 1R01CA296965-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗