Clinical trial NCT04751305: Remote Exercise Maintenance With Health Coaching for Cancer Survivors
Official title: The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Survivors
Keywords: mHealth
Health Coaching
Exercise
Online delivery
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: At the beginning of the remote ACE maintenance program participants are randomized into either the exercise only group or the exercise with additional health coaching group.
Primary purpose: SUPPORTIVE_CARE

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, 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.

Eligibility criteria: Inclusion Criteria:

* Being 18 years or older
* 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:

* Active infections at the time of enrollment
* Enteral tube feeding/parenteral nutrition
* Mechanical or functional bowel obstruction due to any cause
* Cognitive impairment
* non-English speaking
* Neuromusculoskeletal issues that impede participation

Primary outcomes:
measure: Feasibility of Exercise Class Attendance (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
measure: Feasibility of Exercise Class Attendance (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
measure: Feasibility of Exercise Guidelines Adherence (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)
measure: Feasibility of Exercise Guidelines Adherence (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)
measure: Feasibility health coaching call completion (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last week of exercise classes (week 8)
measure: Feasibility health coaching call completion (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last week of exercise classes (week 12)
measure: Feasibility of Recruitment
timeFrame: Started about one month before study beginning and went until beginning of study (week 0)
measure: Fidelity of the health coaching intervention (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
measure: Fidelity of the health coaching intervention (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
measure: Fidelity of the exercise intervention (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
measure: Fidelity of the exercise intervention (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
measure: Feasibility of Study completion (Cohort 1)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
measure: Feasibility of Study completion (Cohort 2)
timeFrame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
measure: Feasibility of Assessment Completion (Questionnaire) (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Feasibility of Assessment Completion (Questionnaire) (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Feasibility of Assessment Completeness (Questionnaire) (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Feasibility of Assessment Completeness (Questionnaire) (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Feasibility of Assessment Completion (Accelerometer) (Cohort 1)
timeFrame: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
measure: Feasibility of Assessment Completion (Accelerometer) (Cohort 2)
timeFrame: Throughout the study from week 1 until end of week 12
measure: Semi-Structured Interview (Feasibility)
timeFrame: Post-intervention (week 9 (first wave) or week 13 (second wave))
Secondary outcomes:
measure: Physical Activity Minutes Per Week (objective) (Cohort 1)
timeFrame: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
measure: Physical Activity Minutes Per Week (objective) (Cohort 2)
timeFrame: Throughout the study from week 1 until end of week 12
measure: Physical Activity Minutes Per Week (subjective) (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Physical Activity Minutes Per Week (subjective) (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Body Composition (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Body Composition (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Aerobic Endurance (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Aerobic Endurance (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Strength Endurance (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Strength Endurance (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Upper extremity flexibility (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Upper extremity flexibility (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Lower extremity flexibility (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Lower extremity flexibility (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Balance (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Balance (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Barrier Self-Efficacy (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Barrier Self-Efficacy (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: General Wellbeing (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: General Wellbeing (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Fatigue (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Fatigue (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Social Support (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Social Support (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Loneliness (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Loneliness (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Stress (Cohort 1)
timeFrame: Before study (week 0) and after study completion (Week 9)
measure: Stress (Cohort 2)
timeFrame: Before study (week 0) and after study completion (Week 13)
measure: Garmin Activity Tracker Usage (Cohort 2)
timeFrame: Post-intervention (week 13)
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Faculty of Kinesiology University of Calgary
state: Alberta
city: Calgary
country: Canada
facility: Health and Wellness Lab, University of Calgary
state: Alberta
Study officials:
References: