Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751305
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2021-01-13
Brief Title:
Remote Exercise Maintenance With Health Coaching for Cancer Survivors
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching
Detailed Description:
Purpose The primary aim of this proposed mixed-methods study is to determine the feasibility of implementing a home-based exercise program with the support of telephone-based health coaching HC The secondary aim is to test the effectiveness of the program on physical activity PA levels psychosocial well-being and physical functioning
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 2xwk for first 2 weeks 1xwk for remaining 6 weeks and 2 online group maintenance classes same tapered format with HC 1xweek 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 proscons 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
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 2xwk for first 2 weeks 1xwk for remaining 6 weeks and 2 online group maintenance classes same tapered format with HC 1xweek 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 proscons 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None