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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.

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.

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.

Health Coaching

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.

Online delivered Exercise Classes

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

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.

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.

The certified exercise physiologists (CEP) instructing the exercise classes were unaware of the intervention each participant was assigned to. The CEP administering the physical functioning assessment was unaware of the participants intervention and was not the participants exercise class instructor.

Remote Exercise Maintenance With Health Coaching for Cancer Survivors

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

Percentage of class attendance by all participants was assessed and deemed feasible if attendance was equal or above 70%.

Percentage of participants meeting the exercise guidelines of 90 minutes of moderate to vigorous physical activity. 80% or higher adherence will be deemed feasible.

Percentage of participants in the health coaching intervention completing all calls. 80% or higher completion will be deemed feasible.

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.

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.

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.

The attrition rate of the study was calculated as the percentage of dropouts out of all participants.

Percentage of all assessments completed by all participants was assessed and deemed feasible if completion was equal or above 70%.

Percentage of all questions within the questionnaire answered by all participants was assessed and deemed feasible if completion was equal or above 70%.

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.

Include participant satisfaction, barrier management, pros/cons to the home-setting, value of the health coaching support, and facilitators to maintaining PA levels.

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.

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.

Change in 2 minute step test (steps) results

Change in sit-to-stand (number of repetitions in 30 seconds)

Change in active shoulder flexion range of motion (degrees)

Change in one legged stance test (seconds)

Change in barrier self-efficacy measured by Rogers et al 9 item scale (0-100).

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"

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".

Change in the Oslo Social Support Scale (OSSS-3) score

Change in the UCLA Loneliness Scale Short Version (ULS-6) score

Change in the Perceived Stress Scale (PSS) score

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.

University of Calgary

Neoplasms

Digestive System Diseases

All Conditions

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Colorectal Neoplasms

Breast Neoplasms

Stomach Neoplasms

Lung Neoplasms

Breast Diseases

Skin Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Stomach Diseases

Stomach Cancer

This group is provided with "Online health management program", "Health coaching" and "Workshop".

This group is provided with "Online health management program".

This group is provided with "Standard health educational booklet".

Web-based health management program designed according to SMASH strategy, which includes (i) Assessment, (ii) Acceptance, (iii) Preparation for change, (iv) Commitment, (v) Planning, (vi) Promoting environment, (vii) Execution, (viii) Feedback and Maintenance, and (ix) Core perspectives, for 6 months.

The program consists of four areas: self-assessment, self-planning, self-learning, and self-monitoring. The learning session includes SMASH strategies and "10 Rules for Highly Effective Health Behavior".

Online health management program

Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program

Health coaching

Total three sessions are to be held at 3-, 5-, and 7-month after the initiation of the enrollment. Each session includes 30-minute health education, 1-hour health management strategy workshop, and 30-minute team coaching.

Workshop

Standard health educational booklets about "10 Rules for Highly Effective Health Behavior" that are organized according to the Trans-theoretical Model (TTM).

Booklets are provided at 0-, 2-, and 4-month after the enrollment.

Standard health educational booklet

Young Ho Yun, MD. PhD

The purpose of this study is to evaluate the efficacy of the "Smart Management Strategy for Health (SMASH)" program, which is designed to help cancer patients overcome their cancer crisis proactively and grow positively.

\<Hypothesis\> This study hypothesizes that the intervention being provided (SMASH program) will demonstrate improvements in cancer survivors' health management in the fields of (i) physical activity, body mass index, and positive growth, (ii) self-management strategies of health (SMASH Assessment Tool; SAT), (iii) overall physical, mental, social, spiritual health conditions and Quality of Life (QoL), and (iv) the execution and maintenance of health habits ("10 Rules for Highly Effective Health Behavior").

\<Patient registry\> Cancer survivors, who have just completed their cancer treatments (surgery, radiation, chemotherapy), will be recruited from five medical centers in Korea and randomly allocated to one of following three groups: 2 experiment groups and 1 attention control group. This recruitment process would start after the approval of protocol by the Institutional Review Board (IRB), and proceed through following steps: (i) the physician in charge confirms that the patient has finished his or her treatment and determines whether the patient is eligible to participate in the study by checking the recent (less than one year) results of the patient's basic medical exams (blood pressure, body temperature, heart rate, respiratory rate, weight, and height) and basic lab tests (blood chemistry, electrocardiogram, chest PA, complete blood count, liver function test, BUN/Cr), (ii) A nurse explains the purpose and method of the study to the patient, and asks to complete informed consent form, (iii) the patient who agrees for participation will complete a brief screening questionnaire (Godin's Leisure Time Exercise, weight/height, and PostTraumatic Growth Inventory(PTGI)), (iv) the patient meeting the criteria as determined by the screening questionnaire is asked to complete the baseline assessment questionnaire at home, (v) cases who finish the baseline assessment questionnaire and meet all criteria are considered study participants and are randomly assigned to one of the three study arms.

\<Quality control (patient data)\> This study assumes that patients who are directly referred to the study by collaborating physicians are valid cancer cases. Data collected from study participants on screening forms will be reviewed by researchers at the central institution for missing responses and inconsistencies.

\<Sample size\>

The sample size of 477 participants was based upon the following assumptions:

* a two-sided Type I error of 0.05
* drop-out rate of 10%
* an attainment of goal behavior of 5% in the active comparator arm and 20% in the experiment arm, and a power of 90% to detect a between-arm difference

\<Statistical analysis plan \> The primary endpoint was based on three-outcome composite achievement of PA, weight and PTGI score at 12 months. All analyses will be conducted on the basis of intention-to-treat. Arm differences at 3, 6, and 12 months in behavior change (physical activity, body mass index, posttraumatic growth) will be tested with logistic regression, controlling for the respective baseline values. Arm differences in levels of Mini Dietary Assessment Index (MDI), execution of health habits, SMASH Assessment Tool (SAT), Quality of Life (QoL), health condition, incurred medical expenses, incurred Complementary and Alternative Medicine (CAM) expenses will be explored using a mixed model that estimates the effect of SMASH program over time, which will correlate repeated observations on particular participants after adjustment for baseline scores.

Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively

A Randomized Controlled Trial of Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively in Cancer Survivors

moderate exercise for ≥150 min/week or strenuous exercise for ≥75 min/week (\* ≥12.5 MET-hr/week for lung cancer patients; no limit on exercise strength)

BMI in kg/m\^2 goal 18.5-22.9 (≥18.5 for lung cancer patients)

General is a quality of life measure with higher scores indicating better quality of life (range 0-105)

Mini Dietary assessment Index (MDI) score ≥ 80

10 Rules for Highly Effective Health Behavior

We measured psychologic distress with the Hospital Anxiety and Depression Scale (HADS), which consists of 14 items (7 for anxiety and 7 for depression).

The Brief Fatigue Inventory (BFI) scale, which consists of 9 items that rate fatigue severity and interference on a 0-to-10 scale,

We assessed the SM strategies of health with the SMASH Assessment Tool (SAT), which is a three-set, 16-factor, 91-item tool (i.e., the core strategies with 28 items, preparation strategies with 30 items, and implementation strategies with 33 items) that assesses the patients' ability to overcome their health-related crisis.

The social support (2 items) and spiritual (6 items) scales of the McGill Quality of Life (McGill QOL)

Samsung Medical Center

Asan Medical Center

Ewha Womans University Mokdong Hospital

National Cancer Center, Korea

Seoul National University Hospital

Professor

Behaviors and Mental Disorders

Quality of Life

All participants will be in the health coaching group. Participants on study will receive a health coach for 6 months.

6 months of integrative health coaching, goal setting, survey administration and physical assessments.

Brianna Castrogivanni, MS

Carly Bailey, MA

William Wood, MD

William A Wood, MD, MPH

Purpose: The HealthScore Health Coaching Program aims to deliver 6-months of 1:1 home-based health coaching to cancer patients receiving treatment and survivors of any diagnosis at UNC Cancer Hospital. This study hopes to preserve physical function, address unmet physical, nutritional, psychological, social and other needs.

Procedures: This will be done through individualized health coaching, weekly symptom survey administration, monthly supportive care questionnaires, and physical assessments at baseline, 3 months and 6 months.

Participants: All cancer patients with appointments at UNC Cancer Hospitals.

Evaluation and monitoring are used sporadically in routine cancer care, and cancer coaching programs are rare. The potential for these approaches to improve quality of life and clinical outcomes in cancer patients is significant. The HealthScore Health Coaching Program is designed as a way to routinely combine evaluation, monitoring and coaching within a single framework as a six-month intervention for cancer patients or survivors. The primary rationale for the Program is that improvements in physical function, unmet needs identification, and self-efficacy are likely to lead to better patient-centered and overall outcomes for patients and survivors. A secondary rationale is that the framework of the Program and data obtained as part of the Program will facilitate additional quality improvement and research activities to refine the application of evaluation, monitoring and coaching techniques in cancer care. As reimbursement and care delivery in oncology transition to a focus on value and population-based management, the HealthScore Health Coaching Program may provide a model for application to cancer care within and outside UNC. The primary purpose of this study is to provide 6-months of 1:1 home-based health coaching for cancer patients and survivors will improve physical function and address unmet physical, nutritional, psychological, social and other needs which will increase patient and survivor self-efficacy for medical engagement, reduce morbidity, health care utilization, and encourage health lifestyle behaviors.

The HealthScore Health Coaching Program

To provide health coaching services for cancer patients and survivors at UNC through the HealthScore Program, measured by calculating numbers of participants enrolled and completing the six-month HealthScore health coaching intervention each year.

Change in PROMIS (Patient Reported Outcomes Measurement Information System) Physical Function 8b on a scale of 0-60.5. Higher scores indicate better physical function.

Percentage of possible coaching phone calls completed

Percentage of possible patient-reported surveys completed

Percentage of possible days using the wearable sensor with evaluable data

Number of unmet needs addressed while participating in health coaching

Magnitude of change in self-efficacy during program participation using the Lorgis Self-efficacy scale. The score is the mean of six items, scored 0-10. Higher scores are better.

UNC Lineberger Comprehensive Cancer Center

This is a study to assess the feasibility of using health coaching sessions in cancer patients. The investigators are investigating whether health coaching sessions can be delivered to this group of participants in a semi structured way. The investigators hope that the study will allow us to see whether such sessions can be delivered in a timely manner that is acceptable to patients and staff. The longer term aim for this work, should it prove feasible, is to conduct a randomised controlled trial to assess health coaching.

The participants for the study will be selected using purposive sampling. The investigators will select a sample of 10 patients. The participants will be patients at the Oxford University Hospitals NHS Trust who are prescribed oral anticancer therapy. The sample will include male and female patients and try to cover a range of ages from 18 upwards. It will cover patients taking a range of oral anticancer agents, for a range of different cancer indications. The sample will look at patients who are newly prescribed oral anticancer therapy through to patients who have been taking therapy for years.

Participants will be identified for the study by multidisciplinary staff members who are running oral education sessions or by non-medical prescribers who are seeing patients in clinic. These members of the MDT will be given lists of the types of participants the investigators are looking for in the study and where appropriate offer patients the opportunity to take part. Patients will be contacted prior to the end of their subsequent cycle of treatment about whether they wish to participate. Patients wishing to take part will be consented at their next clinic visit.

All participants will attend for their usual clinic visits throughout the study. Participants will additionally be offered up to 3 health coaching sessions for a maximum of three cycles or until treatment with their oral anticancer agent ends, whichever comes first.

At the end of study visit participants will be asked to attend a qualitative based interview to discuss the intervention.

Feasibility of Health Coaching in Cancer Patients

A Study to Assess the Feasibility of Using Health Coaching Sessions in Cancer Patients

To assess whether a 10 minute semi standardised health coaching session can be conducted with NHS cancer patients by pharmacists trained in health coaching and to gather the opinions of the patients and the health coaches as to whether the intervention is of benefit and warrants further investigation.

Measures of feasibility include: Recruitment figures, logistics of conducting health coaching sessions, review of the recorded coaching sessions, attendance rates, qualitative analysis of reflection notes and end of study interview with patients, Patient activation measure at baseline and end of study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Remote Exercise Maintenance With Health Coaching for Cancer Survivors	NCT04751305	Cancer Survivor...	Health Coaching Online delivere...	18 Years -	University of Calgary
Efficacy of a Smart Management Strategy for Health (SMASH) Program for Overcoming Cancer Crisis and Growing Positively	NCT02650661	Breast Neoplasm... Lung Neoplasms Colorectal Neop... Stomach Neoplas...	Online health m... Health coaching Workshop Standard health...	19 Years -	Seoul National University Hospital
The HealthScore Health Coaching Program	NCT04923997	Cancer Survivorship Quality of Life Health Behavior	Health Coaching	15 Years -	UNC Lineberger Comprehensive Cancer Center
Feasibility of Health Coaching in Cancer Patients	NCT02556528	Cancer	Health Coaching	18 Years -	Oxford University Hospitals NHS Trust

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