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Exercise for Oncology Care Professionals (C4C+)

Primary Purpose

Burnout, Caregiver, Compassion Fatigue

Status
Not yet recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Circuit-based Resistance Training
Circuit-based Resistance Training + Home-based Walking
Home-based Walking
Sponsored by
Melanie Keats
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout, Caregiver focused on measuring oncology health professionals, burnout, compassion fatigue, exercise, physical activity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Physical Activity and Cancer (PAC) Lab

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Circuit-based resistance exercise

Circuit-based resistance exercise plus home-based walking

Home-based walking

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Feasibility - Recruitment
Participant accrual as defined as the number of eligible participants who consent to participate.
Feasibility - Participant Fidelity (Intervention Adherence)
Participant adherence to prescribed exercise intervention
Feasibility - Safety
Adverse and serious adverse events
Feasibility - Retention/Attrition
Percentage of participants who complete the 12-week intervention
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.
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.

Secondary Outcome Measures

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).
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).
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.
Physical Activity Behavior - Daily step count
Participants asked to record their daily step counts using a wrist worn activity monitor.
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.
Resting heart rate
Resting heart rate
Resting Blood Pressure
Resting systolic and diastolic blood pressure
Aerobic fitness
The six-minute walk test is used to assess aerobic capacity.
Upper Body Strength
A hand-held dynamometer is used to assess upper body strength.
Muscular Endurance
The 30-second sit-to-stand is used to assess lower body muscular endurance.
Body Mass Index
Height and weight is used to assess body mass index

Full Information

First Posted
May 5, 2023
Last Updated
May 30, 2023
Sponsor
Melanie Keats
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1. Study Identification

Unique Protocol Identification Number
NCT05884073
Brief Title
Exercise for Oncology Care Professionals
Acronym
C4C+
Official Title
The Cost of Caring: Examining the Role of Exercise in Mitigating Oncology Care Provider Burnout (C4C+)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melanie Keats

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Caregiver, Compassion Fatigue
Keywords
oncology health professionals, burnout, compassion fatigue, exercise, physical activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Circuit-based resistance exercise
Arm Type
Experimental
Arm Description
12-week, supervised twice weekly circuit-based resistance training program.
Arm Title
Circuit-based resistance exercise plus home-based walking
Arm Type
Experimental
Arm Description
12-week, supervised twice weekly circuit-based resistance training program plus home-based (unsupervised) brisk walking/light jogging program 3 days/week.
Arm Title
Home-based walking
Arm Type
Active Comparator
Arm Description
12-week self-paced walking at home (unsupervised) 3 days/week.
Intervention Type
Behavioral
Intervention Name(s)
Circuit-based Resistance Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Circuit-based Resistance Training + Home-based Walking
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Home-based Walking
Intervention Description
Participants will be asked to engage in 25 minutes of self-paced walking at home (unsupervised) 3 days/week.
Primary Outcome Measure Information:
Title
Feasibility - Recruitment
Description
Participant accrual as defined as the number of eligible participants who consent to participate.
Time Frame
Through study completion (about 1 year)
Title
Feasibility - Participant Fidelity (Intervention Adherence)
Description
Participant adherence to prescribed exercise intervention
Time Frame
Through study completion (about 1 year)
Title
Feasibility - Safety
Description
Adverse and serious adverse events
Time Frame
Through study completion (about 1 year)
Title
Feasibility - Retention/Attrition
Description
Percentage of participants who complete the 12-week intervention
Time Frame
Through study completion (about 1 year)
Title
Feasibility - Participant Experience
Description
Exit interview is used to assess factors influencing participant selection of intervention type/setting, adherence to and satisfaction with the selected intervention.
Time Frame
Through study completion (about 1 year)
Title
Feasibility - Attendance
Description
Attendance is calculated as the percentage of exercise sessions completed by the total number of available exercise sessions over the 12-week intervention.
Time Frame
Through study completion (about 1 year)
Secondary Outcome Measure Information:
Title
Maslach Burnout Inventory (MBI) for Medical Personnel (MP)
Description
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).
Time Frame
Pre to post intervention (12-week change)
Title
Professional Quality of Life Scale (ProQOL)
Description
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).
Time Frame
Pre to post intervention (12-week change)
Title
Depression, Anxiety, and Stress Scale - Short Version (DASS21)
Description
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.
Time Frame
Pre to post intervention (12-week change)
Title
Physical Activity Behavior - Daily step count
Description
Participants asked to record their daily step counts using a wrist worn activity monitor.
Time Frame
Week 1 through Week 12
Title
Physical Activity Behavior - Self-reported
Description
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.
Time Frame
Pre to post intervention (12-week change)
Title
Resting heart rate
Description
Resting heart rate
Time Frame
Pre to post intervention (12-week change)
Title
Resting Blood Pressure
Description
Resting systolic and diastolic blood pressure
Time Frame
Pre to post intervention (12-week change)
Title
Aerobic fitness
Description
The six-minute walk test is used to assess aerobic capacity.
Time Frame
Pre to post intervention (12-week change)
Title
Upper Body Strength
Description
A hand-held dynamometer is used to assess upper body strength.
Time Frame
Pre to post intervention (12-week change)
Title
Muscular Endurance
Description
The 30-second sit-to-stand is used to assess lower body muscular endurance.
Time Frame
Pre to post intervention (12-week change)
Title
Body Mass Index
Description
Height and weight is used to assess body mass index
Time Frame
Pre to post intervention (12-week change)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Keats, PhD
Phone
902-494-7173
Email
melanie.keats@dal.ca
Facility Information:
Facility Name
Physical Activity and Cancer (PAC) Lab
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Keats, PhD
Phone
902-494-7173
Email
melanie.keats@dal.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Exercise for Oncology Care Professionals

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