Exercise for Oncology Care Professionals

Burnout, Caregiver Clinical Trial

— C4C+  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05884073
• Other study ID #: C4C+
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: March 2024
• Source: Nova Scotia Health Authority
• Contact: Melanie Keats, PhD
• Phone: 902-494-7173
• Email: melanie.keats[@]dal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 36
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Caregiver
• Burnout, Psychological
• Caregiver Burden
• Compassion Fatigue
• Fatigue

Intervention

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

Locations

Country	Name	City	State
Canada	Physical Activity and Cancer (PAC) Lab	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
Melanie Keats

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - Recruitment	Participant accrual as defined as the number of eligible participants who consent to participate.	Through study completion (about 1 year)
Primary	Feasibility - Participant Fidelity (Intervention Adherence)	Participant adherence to prescribed exercise intervention	Through study completion (about 1 year)
Primary	Feasibility - Safety	Adverse and serious adverse events	Through study completion (about 1 year)
Primary	Feasibility - Retention/Attrition	Percentage of participants who complete the 12-week intervention	Through study completion (about 1 year)
Primary	Feasibility - Participant Experience	Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the selected intervention.	Through study completion (about 1 year)
Primary	Feasibility - Attendance	Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 12-week intervention.	Through study completion (about 1 year)
Secondary	Maslach Burnout Inventory (MBI) for Medical Personnel (MP)	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).	Pre to post intervention (12-week change)
Secondary	Professional Quality of Life Scale (ProQOL)	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).	Pre to post intervention (12-week change)
Secondary	Depression, Anxiety, and Stress Scale - Short Version (DASS21)	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.	Pre to post intervention (12-week change)
Secondary	Physical Activity Behavior - Daily step count	Participants asked to record their daily step counts using a wrist worn activity monitor.	Week 1 through Week 12
Secondary	Physical Activity Behavior - Self-reported	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.	Pre to post intervention (12-week change)
Secondary	Resting heart rate	Resting heart rate	Pre to post intervention (12-week change)
Secondary	Resting Blood Pressure	Resting systolic and diastolic blood pressure	Pre to post intervention (12-week change)
Secondary	Aerobic fitness	The six-minute walk test is used to assess aerobic capacity.	Pre to post intervention (12-week change)
Secondary	Upper Body Strength	A hand-held dynamometer is used to assess upper body strength.	Pre to post intervention (12-week change)
Secondary	Muscular Endurance	The 30-second sit-to-stand is used to assess lower body muscular endurance.	Pre to post intervention (12-week change)
Secondary	Body Mass Index	Height and weight is used to assess body mass index	Pre to post intervention (12-week change)