C4C+: Exercise for Oncology Care Professionals

Sponsor

Melanie Keats (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05884073

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this preference-based pilot study will be to assess the feasibility, acceptability, and impact of a 12-week exercise intervention on oncology care provider burnout, compassion fatigue, and well-being. Participants will be divided into one of three exercise groups. Group assignment will be based on participant preference.

Group 1: Supervised circuit-based resistance exercise (2 days/week)

Group 2: Supervised circuit-based resistance exercise (2 days/week) + moderate-to-high intensity home-based walking/light jogging program (3 days/week)

Group 3: Self-paced home-based walking program (3 days/week)

Condition or Disease	Intervention/Treatment	Phase
Burnout, Caregiver Compassion Fatigue	Behavioral: Circuit-based Resistance Training Behavioral: Circuit-based Resistance Training + Home-based Walking Behavioral: Home-based Walking	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

The Cost of Caring: Examining the Role of Exercise in Mitigating Oncology Care Provider Burnout (C4C+)

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Aug 31, 2024

Anticipated Study Completion Date :

Aug 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Circuit-based resistance exercise 12-week, supervised twice weekly circuit-based resistance training program.	Behavioral: Circuit-based Resistance Training Participants will engage in a 12-week, twice weekly circuit-based resistance training program. Each supervised session will last about 25 minutes and will consist of 5 resistance exercises. Each exercise will be completed for 1 minute for a total of 5 minutes followed by a 1-minute rest. The circuit will then repeated 3 additional times (total of 4 circuits). All resistance sessions will be supervised by a certified fitness professionals.
Experimental: Circuit-based resistance exercise plus home-based walking 12-week, supervised twice weekly circuit-based resistance training program plus home-based (unsupervised) brisk walking/light jogging program 3 days/week.	Behavioral: Circuit-based Resistance Training + Home-based Walking Participants will engage in a 12-week, twice weekly circuit-based resistance training program. Each supervised session will last about 25 minutes and will consist of 5 resistance exercises. Each exercise will be completed for 1 minute for a total of 5 minutes followed by a 1-minute rest. The circuit will then repeated 3 additional times (total of 4 circuits). All resistance sessions will be supervised by a certified fitness professionals. Participants will also be asked to engage in 25 minutes of brisk power walking or light jogging at home (unsupervised) 3 days/week for 25 minutes on days when they have not engaged in resistance training.
Active Comparator: Home-based walking 12-week self-paced walking at home (unsupervised) 3 days/week.	Behavioral: Home-based Walking Participants will be asked to engage in 25 minutes of self-paced walking at home (unsupervised) 3 days/week.

Arm

Intervention/Treatment

Experimental: Circuit-based resistance exercise

12-week, supervised twice weekly circuit-based resistance training program.

Behavioral: Circuit-based Resistance Training

Experimental: Circuit-based resistance exercise plus home-based walking

12-week, supervised twice weekly circuit-based resistance training program plus home-based (unsupervised) brisk walking/light jogging program 3 days/week.

Behavioral: Circuit-based Resistance Training + Home-based Walking

Participants will engage in a 12-week, twice weekly circuit-based resistance training program. Each supervised session will last about 25 minutes and will consist of 5 resistance exercises. Each exercise will be completed for 1 minute for a total of 5 minutes followed by a 1-minute rest. The circuit will then repeated 3 additional times (total of 4 circuits). All resistance sessions will be supervised by a certified fitness professionals. Participants will also be asked to engage in 25 minutes of brisk power walking or light jogging at home (unsupervised) 3 days/week for 25 minutes on days when they have not engaged in resistance training.

Active Comparator: Home-based walking

12-week self-paced walking at home (unsupervised) 3 days/week.

Behavioral: Home-based Walking

Participants will be asked to engage in 25 minutes of self-paced walking at home (unsupervised) 3 days/week.

Outcome Measures

Primary Outcome Measures

Feasibility - Recruitment [Through study completion (about 1 year)]
Participant accrual as defined as the number of eligible participants who consent to participate.
Feasibility - Participant Fidelity (Intervention Adherence) [Through study completion (about 1 year)]
Participant adherence to prescribed exercise intervention
Feasibility - Safety [Through study completion (about 1 year)]
Adverse and serious adverse events
Feasibility - Retention/Attrition [Through study completion (about 1 year)]
Percentage of participants who complete the 12-week intervention
Feasibility - Participant Experience [Through study completion (about 1 year)]
Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the selected intervention.
Feasibility - Attendance [Through study completion (about 1 year)]
Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 12-week intervention.

Secondary Outcome Measures

Maslach Burnout Inventory (MBI) for Medical Personnel (MP) [Pre to post intervention (12-week change)]
The MBI-MP is used to assess burnout in medical professionals. The 22-item, 7-point Likert scale (0 = never to 6 = everyday) assesses burnout across three dimensions: emotional exhaustion (9 items), personal accomplishment (8 items), and depersonalization (5-items).
Professional Quality of Life Scale (ProQOL) [Pre to post intervention (12-week change)]
The 30-item ProQOL is used to assess compassion fatigue (10 items), compassion satisfaction (10 items), and burnout (10 items). Items are scored on a 5-point Likert scale (1 = never to 5 = very often).
Depression, Anxiety, and Stress Scale - Short Version (DASS21) [Pre to post intervention (12-week change)]
The 21-item DASS is used to assess symptoms associated with three negative emotional states: depression, anxiety, and stress. Each scale contains 7-items scored on a 4-point severity/frequency scale.
Physical Activity Behavior - Daily step count [Week 1 through Week 12]
Participants asked to record their daily step counts using a wrist worn activity monitor.
Physical Activity Behavior - Self-reported [Pre to post intervention (12-week change)]
Self-reported physical activity is assessed by the Godin Leisure Time Exercise Questionnaire. Higher scores indicate higher levels of physical activity. Participants reporting moderate-to-strenuous Leisure Score Index ≥ 24 are classified as active; those reporting moderate-to-strenuous Leisure Score Index ≤ 23 are classified as insufficiently active.
Resting heart rate [Pre to post intervention (12-week change)]
Resting heart rate
Resting Blood Pressure [Pre to post intervention (12-week change)]
Resting systolic and diastolic blood pressure
Aerobic fitness [Pre to post intervention (12-week change)]
The six-minute walk test is used to assess aerobic capacity.
Upper Body Strength [Pre to post intervention (12-week change)]
A hand-held dynamometer is used to assess upper body strength.
Muscular Endurance [Pre to post intervention (12-week change)]
The 30-second sit-to-stand is used to assess lower body muscular endurance.
Body Mass Index [Pre to post intervention (12-week change)]
Height and weight is used to assess body mass index

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

18 years of age or older
Must be providing formal (paid) care to cancer patients in a clinical setting
Actively practicing within the Nova Scotia Cancer Care Program

Exclusion Criteria:

Exceeding Canadian physical activity guidelines of 150-minutes of moderate-to-vigorous physical activity per week
Any health condition that would preclude safe participation in a new exercise program