Cancer SurvivorsNCT04751305
Remote Exercise Maintenance With Health Coaching for Cancer Survivors
A study testing Health Coaching and Online delivered Exercise Classes in people with Cancer Survivors, run by University of Calgary at 2 sites in Canada.
Trial summary
The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Survivors
- What is being tested?
- Health Coaching and Online delivered Exercise Classes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesCanada
- Study dates
- 27 May 2020to 11 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Faculty of Kinesiology University of Calgary
Calgary, Alberta, T2N 1N4
Health and Wellness Lab, University of Calgary
Calgary, Alberta, T2N 1N4
About this study
Official title: The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.
The feasibility of an online maintenance exercise program for cancer survivors supported by health coaching.
Read the 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.
- Conditions
- Cancer Survivors
- Being tested
- Health Coaching, Online delivered Exercise Classes
- Keywords
- mHealth, Health Coaching, Exercise, Online delivery
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
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 ClassesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| ACE Remote Maintenance Program with Health Coaching | Experimental | 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. Receives: Behavioral: Health Coaching; Behavioral: Online delivered Exercise Classes |
| Only ACE Remote Maintenance Program | Active comparator | 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. Receives: Behavioral: Online delivered Exercise Classes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
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%.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
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.
Measured: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)
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.
Measured: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)
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.
Measured: Beginning of exercise classes (week 1) until last week of exercise classes (week 8)
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.
Measured: Beginning of exercise classes (week 1) until last week of exercise classes (week 12)
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.
Measured: Started about one month before study beginning and went until beginning of study (week 0)
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.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
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.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
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.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
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.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Feasibility of Study completion (Cohort 1)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Feasibility of Study completion (Cohort 2)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Measured: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
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%.
Measured: Before study (week 0) and after study completion (Week 9)
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%.
Measured: Before study (week 0) and after study completion (Week 13)
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%.
Measured: Before study (week 0) and after study completion (Week 9)
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%.
Measured: Before study (week 0) and after study completion (Week 13)
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%.
Measured: Before study (week 0) and after study completion (Week 9)
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%.
Measured: Before study (week 0) and after study completion (Week 13)
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.
Measured: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
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.
Measured: Throughout the study from week 1 until end of week 12
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.
Measured: Post-intervention (week 9 (first wave) or week 13 (second wave))
Secondary outcomes (29)
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.
Measured: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
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.
Measured: Throughout the study from week 1 until end of week 12
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.
Measured: Before study (week 0) and after study completion (Week 9)
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.
Measured: Before study (week 0) and after study completion (Week 13)
Body Composition (Cohort 1)
Change in body mass index (BMI)
Measured: Before study (week 0) and after study completion (Week 9)
Body Composition (Cohort 2)
Change in body mass index (BMI)
Measured: Before study (week 0) and after study completion (Week 13)
Aerobic Endurance (Cohort 1)
Change in 2 minute step test (steps) results
Measured: Before study (week 0) and after study completion (Week 9)
Aerobic Endurance (Cohort 2)
Change in 2 minute step test (steps) results
Measured: Before study (week 0) and after study completion (Week 13)
Strength Endurance (Cohort 1)
Change in sit-to-stand (number of repetitions in 30 seconds)
Measured: Before study (week 0) and after study completion (Week 9)
Strength Endurance (Cohort 2)
Change in sit-to-stand (number of repetitions in 30 seconds)
Measured: Before study (week 0) and after study completion (Week 13)
Upper extremity flexibility (Cohort 1)
Change in active shoulder flexion range of motion (degrees)
Measured: Before study (week 0) and after study completion (Week 9)
Upper extremity flexibility (Cohort 2)
Change in active shoulder flexion range of motion (degrees)
Measured: Before study (week 0) and after study completion (Week 13)
Lower extremity flexibility (Cohort 1)
Change in sit-and-reach test (cm)
Measured: Before study (week 0) and after study completion (Week 9)
Lower extremity flexibility (Cohort 2)
Change in sit-and-reach test (cm)
Measured: Before study (week 0) and after study completion (Week 13)
Balance (Cohort 1)
Change in one legged stance test (seconds)
Measured: Before study (week 0) and after study completion (Week 9)
Balance (Cohort 2)
Change in one legged stance test (seconds)
Measured: Before study (week 0) and after study completion (Week 13)
Barrier Self-Efficacy (Cohort 1)
Change in barrier self-efficacy measured by Rogers et al 9 item scale (0-100).
Measured: Before study (week 0) and after study completion (Week 9)
Barrier Self-Efficacy (Cohort 2)
Change in barrier self-efficacy measured by Rogers et al 9 item scale (0-100).
Measured: Before study (week 0) and after study completion (Week 13)
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"
Measured: Before study (week 0) and after study completion (Week 9)
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"
Measured: Before study (week 0) and after study completion (Week 13)
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".
Measured: Before study (week 0) and after study completion (Week 9)
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".
Measured: Before study (week 0) and after study completion (Week 13)
Social Support (Cohort 1)
Change in the Oslo Social Support Scale (OSSS-3) score
Measured: Before study (week 0) and after study completion (Week 9)
Social Support (Cohort 2)
Change in the Oslo Social Support Scale (OSSS-3) score
Measured: Before study (week 0) and after study completion (Week 13)
Loneliness (Cohort 1)
Change in the UCLA Loneliness Scale Short Version (ULS-6) score
Measured: Before study (week 0) and after study completion (Week 9)
Loneliness (Cohort 2)
Change in the UCLA Loneliness Scale Short Version (ULS-6) score
Measured: Before study (week 0) and after study completion (Week 13)
Stress (Cohort 1)
Change in the Perceived Stress Scale (PSS) score
Measured: Before study (week 0) and after study completion (Week 9)
Stress (Cohort 2)
Change in the Perceived Stress Scale (PSS) score
Measured: Before study (week 0) and after study completion (Week 13)
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.
Measured: Post-intervention (week 13)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2021
- Study start27 May 2020
- Primary completion11 Dec 2020
- Study completion11 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cancer SurvivorsStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04751305
- Sponsor's protocol ID
- HREBA.CC-19-0206
- Status last verified
- Dec 2020
- First submitted
- 13 Jan 2021
- Last updated
- 12 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37173764
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility of a Remote Maintenance Exercise Program for Cancer Survivors Supported by Health Coaching.
- ClinicalTrials.gov ID
- NCT04751305
- Acronym / sponsor ID
- HREBA.CC-19-0206
- Conditions
- Cancer Survivors
- Keywords
- mHealth, Health Coaching, Exercise, Online delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 11 Dec 2020 (actual)
- Study completion
- 11 Dec 2020 (actual)
- First posted
- 12 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| ACE Remote Maintenance Program with Health Coaching | Experimental | Behavioral: Health Coaching, Behavioral: Online delivered Exercise ClassesThe 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. |
| Only ACE Remote Maintenance Program | Active comparator | Behavioral: Online delivered Exercise ClassesThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CoachingThe 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. | Behavioural | ACE Remote Maintenance Program with Health Coaching |
| Online delivered Exercise ClassesThe 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. | Behavioural | ACE Remote Maintenance Program with Health Coaching, Only ACE Remote Maintenance Program |
Primary outcome
Feasibility of Exercise Class Attendance (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.
Feasibility of Exercise Class Attendance (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.
Feasibility of Exercise Guidelines Adherence (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 8)
Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.
Feasibility of Exercise Guidelines Adherence (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last week of exercise classes (end of week 12)
Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.
Feasibility health coaching call completion (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last week of exercise classes (week 8)
Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.
Feasibility health coaching call completion (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last week of exercise classes (week 12)
Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.
Feasibility of Recruitment
Time frame: Started about one month before study beginning and went until beginning of study (week 0)
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.
Fidelity of the health coaching intervention (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
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.
Fidelity of the health coaching intervention (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
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.
Fidelity of the exercise intervention (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
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.
Fidelity of the exercise intervention (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
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.
Feasibility of Study completion (Cohort 1)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Feasibility of Study completion (Cohort 2)
Time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 12)
The attrition rate of the study was calculated as the percentage of dropouts out of all participants.
Feasibility of Assessment Completion (Questionnaire) (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Questionnaire) (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completeness (Questionnaire) (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completeness (Questionnaire) (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Physical functioning assessment) (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.
Feasibility of Assessment Completion (Accelerometer) (Cohort 1)
Time frame: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
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.
Feasibility of Assessment Completion (Accelerometer) (Cohort 2)
Time frame: Throughout the study from week 1 until end of week 12
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.
Semi-Structured Interview (Feasibility)
Time frame: Post-intervention (week 9 (first wave) or week 13 (second wave))
Include participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.
29 secondary outcomes
Physical Activity Minutes Per Week (objective) (Cohort 1)
Time frame: Throughout the study from week 4 (due to COVID related delivery delays) until end of week 8
Physical Activity Minutes Per Week (objective) (Cohort 2)
Time frame: Throughout the study from week 1 until end of week 12
Physical Activity Minutes Per Week (subjective) (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Physical Activity Minutes Per Week (subjective) (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Body Composition (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Body Composition (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Aerobic Endurance (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Aerobic Endurance (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Strength Endurance (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Strength Endurance (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Upper extremity flexibility (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Upper extremity flexibility (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Lower extremity flexibility (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Lower extremity flexibility (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Balance (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Balance (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Barrier Self-Efficacy (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Barrier Self-Efficacy (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
General Wellbeing (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
General Wellbeing (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Fatigue (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Fatigue (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Social Support (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Social Support (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Loneliness (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Loneliness (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Stress (Cohort 1)
Time frame: Before study (week 0) and after study completion (Week 9)
Stress (Cohort 2)
Time frame: Before study (week 0) and after study completion (Week 13)
Garmin Activity Tracker Usage (Cohort 2)
Time frame: Post-intervention (week 13)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
- Derived from this study: PubMed 37173764Eisele 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching and Online delivered Exercise Classes in people with Cancer Survivors, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Exercise Class Attendance (Cohort 1) (time frame: Beginning of exercise classes (week 1) until last day of exercise classes (week 8)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04751305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.