Remote Exercise Maintenance With Health Coaching for Cancer Survivors

Cancer Survivors Clinical Trial

Official title:

The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751305
• Other study ID #: HREBA.CC-19-0206
• Status: Completed
• Phase: N/A
• Start date: May 27, 2020
• Est. completion date: December 11, 2020

Study information

• Verified date: December 2020
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 11, 2020
• Est. primary completion date: December 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer Survivors

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Canada	Faculty of Kinesiology University of Calgary	Calgary	Alberta
Canada	Health and Wellness Lab, University of Calgary	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Exercise Class Attendance (Cohort 1)	Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.	Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Primary	Feasibility of Exercise Class Attendance (Cohort 2)	Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.	Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Primary	Feasibility of Exercise Guidelines Adherence (Cohort 1)	Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.	Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)
Primary	Feasibility of Exercise Guidelines Adherence (Cohort 2)	Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.	Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)
Primary	Feasibility health coaching call completion (Cohort 1)	Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.	Beginning of exercise classes (week 1) until last week of exercise classes (week 8)
Primary	Feasibility health coaching call completion (Cohort 2)	Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.	Beginning of exercise classes (week 1) until last week of exercise classes (week 12)
Primary	Feasibility of Recruitment	Percentage of participants signing up for the study over the eligible cancer survivors will be calculated. 50% or higher recruitment rate will be deemed feasible.	Started about one month before study beginning and went until beginning of study (week 0)
Primary	Fidelity of the health coaching intervention (Cohort 1)	The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.	Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Primary	Fidelity of the health coaching intervention (Cohort 2)	The fidelity of the health coaching intervention will be reported based on how close the intervention followed the protocol. Two sessions of each participant were randomly recorded (through envelope draw). After study completion a research assistant will analyze the recording with the health coaching protocol checklist. The research assistant will report percent agreement with the protocol (9 items for each health coaching session) and the time spent on each part of the health coaching call.	Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Primary	Fidelity of the exercise intervention (Cohort 1)	The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.	Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Primary	Fidelity of the exercise intervention (Cohort 2)	The fidelity of the exercise intervention will be reported based on how close the intervention followed the protocol. The research coordinator joined each exercise class, reported on the class and compared the class structure to the exercise protocol checklist (4 items for each exercise class (including: Alterations to pre-class, warm-up, exercise circuits, cool-down, and post-class conversation)). Percent agreement between protocol and intervention across all classes will be reported. Additionally, the amount of times participants showed up late and the amount of times technical difficulties arose (including audio/video and log in complications) will be reported.	Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Primary	Feasibility of Study completion (Cohort 1)	The attrition rate of the study was calculated as the percentage of dropouts out of all participants.	Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Primary	Feasibility of Study completion (Cohort 2)	The attrition rate of the study was calculated as the percentage of dropouts out of all participants.	Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Primary	Feasibility of Assessment Completion (Questionnaire) (Cohort 1)	Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 9)
Primary	Feasibility of Assessment Completion (Questionnaire) (Cohort 2)	Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 13)
Primary	Feasibility of Assessment Completeness (Questionnaire) (Cohort 1)	Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 9)
Primary	Feasibility of Assessment Completeness (Questionnaire) (Cohort 2)	Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 13)
Primary	Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 1)	Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 9)
Primary	Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 2)	Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.	Before study (week 0) and after study completion (Week 13)
Primary	Feasibility of Assessment Completion (Accelerometer) (Cohort 1)	Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.	Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
Primary	Feasibility of Assessment Completion (Accelerometer) (Cohort 2)	Percentage of days accelerometer was worn as intended was assessed and deemed feasible if completed wear time days were equal or above 70% of overall study days. The accelerometer wearing time was calculated as following: a day was counted if the accelerometer was worn for more than 10 hours, the percentage of days worn over the overall days of the study was calculated.	Throughout the study from week 1 until end of week 12
Primary	Semi-Structured Interview (Feasibility)	Include participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.	Post-intervention (week 9 (first wave) or week 13 (second wave))
Secondary	Physical Activity Minutes Per Week (objective) (Cohort 1)	Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on accelerometer data from commercially-available activity tracker.; For the activity tracker each minute in the 55-70% age predicted HRmax will be evaluated as moderate intensity and above 70% of HRmax will be evaluated as vigorous intensity.; Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes.	Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
Secondary	Physical Activity Minutes Per Week (objective) (Cohort 2)	Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on accelerometer data from commercially-available activity tracker.; For the activity tracker each minute in the 55-70% age predicted HRmax will be evaluated as moderate intensity and above 70% of HRmax will be evaluated as vigorous intensity.; Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes.	Throughout the study from week 1 until end of week 12
Secondary	Physical Activity Minutes Per Week (subjective) (Cohort 1)	Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on the modified Godin Leisure Time Exercise Questionnaire (mGLTEQ).; In the mGLTEQ all dimensions (strenuous exercise, moderate exercise, mild exercise, resistance training, and flexibility) will be looked at separately and weekly minutes will be calculated by multiplying duration times frequency of sessions.; Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes.	Before study (week 0) and after study completion (Week 9)
Secondary	Physical Activity Minutes Per Week (subjective) (Cohort 2)	Change in activity levels from pre to post; Number of participants meeting Guidelines for Physical Activity of 90 minutes per week of moderate to vigorous intensity exercise, based on the modified Godin Leisure Time Exercise Questionnaire (mGLTEQ).; In the mGLTEQ all dimensions (strenuous exercise, moderate exercise, mild exercise, resistance training, and flexibility) will be looked at separately and weekly minutes will be calculated by multiplying duration times frequency of sessions.; Vigorous intensity minutes of physical activity will be doubled and added with moderate intensity minutes to obtain moderate to vigorous physical activity (MVPA) minutes.	Before study (week 0) and after study completion (Week 13)
Secondary	Body Composition (Cohort 1)	Change in body mass index (BMI)	Before study (week 0) and after study completion (Week 9)
Secondary	Body Composition (Cohort 2)	Change in body mass index (BMI)	Before study (week 0) and after study completion (Week 13)
Secondary	Aerobic Endurance (Cohort 1)	Change in 2 minute step test (steps) results	Before study (week 0) and after study completion (Week 9)
Secondary	Aerobic Endurance (Cohort 2)	Change in 2 minute step test (steps) results	Before study (week 0) and after study completion (Week 13)
Secondary	Strength Endurance (Cohort 1)	Change in sit-to-stand (number of repetitions in 30 seconds)	Before study (week 0) and after study completion (Week 9)
Secondary	Strength Endurance (Cohort 2)	Change in sit-to-stand (number of repetitions in 30 seconds)	Before study (week 0) and after study completion (Week 13)
Secondary	Upper extremity flexibility (Cohort 1)	Change in active shoulder flexion range of motion (degrees)	Before study (week 0) and after study completion (Week 9)
Secondary	Upper extremity flexibility (Cohort 2)	Change in active shoulder flexion range of motion (degrees)	Before study (week 0) and after study completion (Week 13)
Secondary	Lower extremity flexibility (Cohort 1)	Change in sit-and-reach test (cm)	Before study (week 0) and after study completion (Week 9)
Secondary	Lower extremity flexibility (Cohort 2)	Change in sit-and-reach test (cm)	Before study (week 0) and after study completion (Week 13)
Secondary	Balance (Cohort 1)	Change in one legged stance test (seconds)	Before study (week 0) and after study completion (Week 9)
Secondary	Balance (Cohort 2)	Change in one legged stance test (seconds)	Before study (week 0) and after study completion (Week 13)
Secondary	Barrier Self-Efficacy (Cohort 1)	Change in barrier self-efficacy measured by Rogers et al 9 item scale (0-100).	Before study (week 0) and after study completion (Week 9)
Secondary	Barrier Self-Efficacy (Cohort 2)	Change in barrier self-efficacy measured by Rogers et al 9 item scale (0-100).	Before study (week 0) and after study completion (Week 13)
Secondary	General Wellbeing (Cohort 1)	Change in overall Functional Assessment of Cancer Therapy - General subscale (FACT-G) score as well as the single domains (Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being); - scale is from 0-4, where 0 means "not at all" and 4 means "very much"	Before study (week 0) and after study completion (Week 9)
Secondary	General Wellbeing (Cohort 2)	Change in overall Functional Assessment of Cancer Therapy - General subscale (FACT-G) score as well as the single domains (Physical Well-being, Social/Family Well-being, Emotional Well-being, Functional Well-being); - scale is from 0-4, where 0 means "not at all" and 4 means "very much"	Before study (week 0) and after study completion (Week 13)
Secondary	Fatigue (Cohort 1)	Change in the overall Functional Assessment of Chronic Illness Therapy - Fatigue subscale (FACIT-F) score; - scale is from 0-4, where 0 means "not at all" and 4 means "very much".	Before study (week 0) and after study completion (Week 9)
Secondary	Fatigue (Cohort 2)	Change in the overall Functional Assessment of Chronic Illness Therapy - Fatigue subscale (FACIT-F) score; - scale is from 0-4, where 0 means "not at all" and 4 means "very much".	Before study (week 0) and after study completion (Week 13)
Secondary	Social Support (Cohort 1)	Change in the Oslo Social Support Scale (OSSS-3) score	Before study (week 0) and after study completion (Week 9)
Secondary	Social Support (Cohort 2)	Change in the Oslo Social Support Scale (OSSS-3) score	Before study (week 0) and after study completion (Week 13)
Secondary	Loneliness (Cohort 1)	Change in the UCLA Loneliness Scale Short Version (ULS-6) score	Before study (week 0) and after study completion (Week 9)
Secondary	Loneliness (Cohort 2)	Change in the UCLA Loneliness Scale Short Version (ULS-6) score	Before study (week 0) and after study completion (Week 13)
Secondary	Stress (Cohort 1)	Change in the Perceived Stress Scale (PSS) score	Before study (week 0) and after study completion (Week 9)
Secondary	Stress (Cohort 2)	Change in the Perceived Stress Scale (PSS) score	Before study (week 0) and after study completion (Week 13)
Secondary	Garmin Activity Tracker Usage (Cohort 2)	Participants were asked how frequently they used the following features on the Garmin Vivosmart4: Steps, Floors climbed, Activity Tracking, Intensity minutes tracking, Heart Rate tracking, Sleep monitoring, Stress monitoring, Body battery, and Calories burned. The answer options for the use of each Garmin function were: Never, Once, Twice, Once every two weeks, Once a week, twice a week, almost every day, every day, or multiple times a day.	Post-intervention (week 13)