Remote Exercise Maintenance With Health Coaching for Cancer Survivors
NCT ID: NCT04751305
Last Updated: 2021-02-12
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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COMPLETED
NA
39 participants
INTERVENTIONAL
2020-05-27
2020-12-11
Brief Summary
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Detailed Description
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Background: Cancer is the leading cause of death in Canada, and one in two Canadians will be diagnosed with cancer in their lifetime. Cancer treatments can prolong life, however it is often at the expense of a multitude of negative symptoms and side-effects that diminish quality of life (QOL). Exercise is one of the most effective and safe options among non-pharmaceutical interventions to manage the psychological and physiological side effects of cancer. Despite the known benefits, PA levels amongst cancer survivors are low. The main barriers to exercise in cancer survivors include lack of time, treatment-related side effects, and fatigue. One factor used to address these potential barriers is to have flexibility in programming, including varying sites for delivery of programs (centre vs home). While there is a preference towards home-based programs, adherence and maintenance rates are generally lower compared to group-based programs.
Rationale: Home-based programs can address the preferences of cancer survivors and potential barriers of exercise, such as access and lack of time. However, there is a need to increase adherence in a home-based program setting.
Objectives/ Research Question: The primary outcome measure of this pilot study is feasibility, while the secondary outcome measures include PA levels, physical functioning, and patient reported outcomes (PRO). We hypothesize that a home-based exercise program, designed to promote self-efficacy and supported by HC, will be maintained, and will improve physical activity levels, self-efficacy in managing the additional burden of isolation, and symptom management, such as chronic fatigue and QOL. The data collected will be used to inform the implementation of a home-based maintenance exercise program.
Research Plan: Assessments of the two intervention arms 1) online group maintenance classes (tapered sessions, 2x/wk for first 2 weeks; 1x/wk for remaining 6 weeks); and 2) online group maintenance classes (same tapered format) with HC (1x/week for approximately 30 minutes) will occur at baseline and post intervention. The first wave of the intervention was run from May until July 2020 for 8 weeks and the second wave was run from September until December 2020 for 12 weeks. Feasibility is the primary outcome measure, including recruitment rate (% who participate from those eligible), assessment completion, safety (adverse event reporting), attendance to remote maintenance classes, HC call completion, and attrition rates. Secondary outcomes include PROs of fatigue, loneliness, stress, social support, self-efficacy, QOL, and PA levels; and measures of physical functioning. Fatigue will be assessed using the FACIT-F. Social support will be assessed through the OSSS-3. Stress and loneliness will be assessed with the PSS and ULS-6 respectively. Self-efficacy will be assessed with a modified barrier SE scale and QOL with the FACT-general questionnaire. PA levels will be monitored objectively through weekly PA levels recorded with an accelerometer, and pre-/post intervention with the self-reported GLTEQ. Physical functioning assessments will be conducted remotely with a clinical exercise physiologist. Semi-structured interviews conducted post-intervention will focus on feasibility, including participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.
Significance: Exercise improves physical and psychological symptom burden from cancer treatment and enhances QOL. During COVID necessitated social isolation, a feasible and effective home-based exercise program may increase the capacity of cancer survivors to engage in regular physical activity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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ACE Remote Maintenance Program with Health Coaching
The participants received online delivered (over zoom) group based exercise classes (2x/wk for first 2 weeks; 1x/wk for the remaining weeks) followed by a 15 minute post workout social session. Participants also received a PDF of a home-based exercise program with embedded videos and a Garmin Vivosmart4 activity tracker. The accelerometer is not intended to be an active part of the intervention but is used to gather an objective measure of PA levels. Additionally, the health coaching intervention received weekly zoom calls that were focused on being participant-centered, built on a coach participant relationship, and included participant-determined goals, a self-discovery process to find solutions, patient accountability, and education.
Health Coaching
The weekly health coaching (HC) calls were structured to be participant-centered, built on a coach participant relationship, and include participant-determined goals, a self-discovery process to find solutions, patient accountability, and education. Before each HC call, the participants received a short questionnaire on fatigue, QOL, stress, loneliness, and social support which enabled tailoring the HC call to the individual. Educational topics are discussed in the following order: Goal Setting, Monitoring Behaviour, Barrier Management, Social Support, Stress Management, Adapting the Program, Self-Compassion, Sleep \& Nutrition, Reflection, Health Media, Remote Resources, and Maintaining Motivation. However, the order of the educational topics can be adjusted based on the specific participants' needs each week. At the half-way point of the intervention, the participant provided feedback on the HC calls, ensuring optimization of HC impact.
Online delivered Exercise Classes
The group based remote exercise program was delivered over the Zoom application (2x/wk for first 2 weeks; 1x/wk for the remaining weeks). Classes were one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretch. Each class was followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.
Only ACE Remote Maintenance Program
The participants received online delivered (over zoom) group based exercise classes (2x/wk for first 2 weeks; 1x/wk for the remaining weeks) followed by a 15 minute post workout social session. Participants also participants received a PDF of a home-based exercise program with embedded videos and a Garmin Vivosmart4 activity tracker. The accelerometer is not intended to be an active part of the intervention but is used to gather an objective measure of PA levels.
Online delivered Exercise Classes
The group based remote exercise program was delivered over the Zoom application (2x/wk for first 2 weeks; 1x/wk for the remaining weeks). Classes were one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretch. Each class was followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.
Interventions
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Health Coaching
The weekly health coaching (HC) calls were structured to be participant-centered, built on a coach participant relationship, and include participant-determined goals, a self-discovery process to find solutions, patient accountability, and education. Before each HC call, the participants received a short questionnaire on fatigue, QOL, stress, loneliness, and social support which enabled tailoring the HC call to the individual. Educational topics are discussed in the following order: Goal Setting, Monitoring Behaviour, Barrier Management, Social Support, Stress Management, Adapting the Program, Self-Compassion, Sleep \& Nutrition, Reflection, Health Media, Remote Resources, and Maintaining Motivation. However, the order of the educational topics can be adjusted based on the specific participants' needs each week. At the half-way point of the intervention, the participant provided feedback on the HC calls, ensuring optimization of HC impact.
Online delivered Exercise Classes
The group based remote exercise program was delivered over the Zoom application (2x/wk for first 2 weeks; 1x/wk for the remaining weeks). Classes were one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretch. Each class was followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Cancer within the last 3 years
* Passed Physical Activity Readiness Questionnaire + (PAR-Q+)
* Completed at an ACE baseline class
* Have access to a computer, laptop, iPad or Tablet with a video camera (with the Zoom app installed)
* Have access to an internet connection strong enough to support a live video broadcast
Exclusion Criteria
* Enteral tube feeding/parenteral nutrition
* Mechanical or functional bowel obstruction due to any cause
* Cognitive impairment
* non-English speaking
* Neuromusculoskeletal issues that impede participation
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Locations
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Faculty of Kinesiology University of Calgary
Calgary, Alberta, Canada
Health and Wellness Lab, University of Calgary
Calgary, Alberta, Canada
Countries
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References
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Eisele M, Pohl AJ, McDonough MH, McNeely ML, Ester M, Daun JT, Twomey R, Culos-Reed SN. The online delivery of exercise oncology classes supported with health coaching: a parallel pilot randomized controlled trial. Pilot Feasibility Stud. 2023 May 12;9(1):82. doi: 10.1186/s40814-023-01316-z.
Other Identifiers
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HREBA.CC-19-0206
Identifier Type: -
Identifier Source: org_study_id
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