Exercise for Oncology Care Professionals (C4C+)

March 8, 2024 updated by: Melanie Keats

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

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)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Physical Activity and Cancer (PAC) Lab
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility - Recruitment
Time Frame: Through study completion (about 1 year)
Participant accrual as defined as the number of eligible participants who consent to participate.
Through study completion (about 1 year)
Feasibility - Participant Fidelity (Intervention Adherence)
Time Frame: Through study completion (about 1 year)
Participant adherence to prescribed exercise intervention
Through study completion (about 1 year)
Feasibility - Safety
Time Frame: Through study completion (about 1 year)
Adverse and serious adverse events
Through study completion (about 1 year)
Feasibility - Retention/Attrition
Time Frame: Through study completion (about 1 year)
Percentage of participants who complete the 12-week intervention
Through study completion (about 1 year)
Feasibility - Participant Experience
Time Frame: 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.
Through study completion (about 1 year)
Feasibility - Attendance
Time Frame: 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.
Through study completion (about 1 year)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resting heart rate
Time Frame: Pre to post intervention (12-week change)
Resting heart rate
Pre to post intervention (12-week change)
Resting Blood Pressure
Time Frame: Pre to post intervention (12-week change)
Resting systolic and diastolic blood pressure
Pre to post intervention (12-week change)
Maslach Burnout Inventory (MBI) for Medical Personnel (MP)
Time Frame: 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).
Pre to post intervention (12-week change)
Professional Quality of Life Scale (ProQOL)
Time Frame: 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).
Pre to post intervention (12-week change)
Depression, Anxiety, and Stress Scale - Short Version (DASS21)
Time Frame: 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.
Pre to post intervention (12-week change)
Physical Activity Behavior - Daily step count
Time Frame: Week 1 through Week 12
Participants asked to record their daily step counts using a wrist worn activity monitor.
Week 1 through Week 12
Physical Activity Behavior - Self-reported
Time Frame: 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.
Pre to post intervention (12-week change)
Aerobic fitness
Time Frame: Pre to post intervention (12-week change)
The six-minute walk test is used to assess aerobic capacity.
Pre to post intervention (12-week change)
Upper Body Strength
Time Frame: Pre to post intervention (12-week change)
A hand-held dynamometer is used to assess upper body strength.
Pre to post intervention (12-week change)
Muscular Endurance
Time Frame: Pre to post intervention (12-week change)
The 30-second sit-to-stand is used to assess lower body muscular endurance.
Pre to post intervention (12-week change)
Body Mass Index
Time Frame: Pre to post intervention (12-week change)
Height and weight is used to assess body mass index
Pre to post intervention (12-week change)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melanie Keats

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

May 5, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4C+

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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