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Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Exercise and self-management
Sponsored by
Hamilton Health Sciences Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Community-dwelling, English-speaking women, over 18 years, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise

Exclusion Criteria:

  • Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise

Sites / Locations

  • McMaster University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Usual Care

Arm Description

The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components. The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation. The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions.

Control group receiving usual care (no exercise or self-management education within the institution).

Outcomes

Primary Outcome Measures

Study Recruitment Rate: percentage of eligible patients recruited
A recruitment log will be kept, detailing reasons for non-participation.
Intervention Retention Rate: percentage of consented participants who completed the intervention
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Intervention Adherence Rate: percentage of total intervention sessions attended
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log

Secondary Outcome Measures

Health related quality of life
Functional Assessment of Cancer Therapy-Breast
Exercise knowledge
Theory of planned behaviour questionnaire
Exercise behaviour
Theory of planned behaviour questionnaire
Health status
European Quality of Life-Five Dimension (EQ-5D)
Use of health care services
Piloted form assessing doctor visits, procedures, medication use, missed days of work
Physical Activity Level
Godin Leisure Time Physical Activity Questionnaire

Full Information

First Posted
March 7, 2017
Last Updated
February 20, 2019
Sponsor
Hamilton Health Sciences Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03087461
Brief Title
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
Official Title
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
October 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hamilton Health Sciences Corporation

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
Breast cancer (BC) and its treatments lead to numerous side effects that affect a person's life for years after treatment has ended. Research shows that regular exercise limits many of these side effects. However, less than 30% of BC survivors regularly exercise due to many barriers that include patients being unaware of the benefits of exercise, health professionals facing institutional, personal, and patient-related barriers to promoting exercise, and a lack of knowledge translation (KT) strategies within cancer institutions that focus on accessible exercise interventions and education by physiotherapists. For this project, a pilot study is needed as the first step in order to assess process and resource variables before implementation of a large-scale intervention. The primary objective of this pilot trial is to assess the feasibility of conducting a larger trial to evaluate the effects of a novel KT intervention using exercise and self-management versus usual care among BC survivors. The secondary objective is to determine preliminary estimates of effects of the KT intervention of exercise plus self-management (SM) program versus usual care on (a) levels of exercise knowledge and behaviour, (b) health related quality of life and (c) resource utilization, among BC survivors over a four month period.
Detailed Description
Study Design: Pilot randomized controlled trial. Eligibility: Women older than 18 years who are currently undergoing chemotherapy treatment for BC. Intervention: The intervention group includes an 8-session multi-component intervention with a structured aerobic exercise program plus SM supervised by a physiotherapist. Setting: Outpatient-Juravinski Cancer Centre in Hamilton, ON. Control: Usual care. Randomization: Participants will be randomly allocated using a 1:1 allocation ratio to receive the intervention of structured exercise plus SM program or usual care. Sample size: The study will recruit n=12 number of participants/group for a total of 24 in both groups. Analysis: A blinded assessor will assess outcomes at baseline, post intervention, at 2- and 4-month follow up. Intervention feasibility and effectiveness will be assessed using descriptive statistics and analysis of covariance for continuous outcomes. Anticipated Impact: This study aims to assess the feasibility of a larger trial to determine effective ways to close the current KT gap and increase exercise awareness for women with BC. This project will assess process and resource variables before implementation of a larger scale intervention. Together, the overall project goal is to promote sustainable exercise behaviour to help manage the burden of BC.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components. The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation. The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Control group receiving usual care (no exercise or self-management education within the institution).
Intervention Type
Behavioral
Intervention Name(s)
Exercise and self-management
Intervention Description
The intervention will include aerobic exercise and self-management education using technology.
Primary Outcome Measure Information:
Title
Study Recruitment Rate: percentage of eligible patients recruited
Description
A recruitment log will be kept, detailing reasons for non-participation.
Time Frame
Baseline
Title
Intervention Retention Rate: percentage of consented participants who completed the intervention
Description
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Time Frame
Post-intervention (2 months post baseline)
Title
Intervention Adherence Rate: percentage of total intervention sessions attended
Description
Attendance will be tracked on the feasibility data collection sheet and reasons for non-participation on scheduled intervention days will be documented using an adherence log
Time Frame
Post-intervention (2 months post baseline)
Secondary Outcome Measure Information:
Title
Health related quality of life
Description
Functional Assessment of Cancer Therapy-Breast
Time Frame
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Title
Exercise knowledge
Description
Theory of planned behaviour questionnaire
Time Frame
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Title
Exercise behaviour
Description
Theory of planned behaviour questionnaire
Time Frame
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Title
Health status
Description
European Quality of Life-Five Dimension (EQ-5D)
Time Frame
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Title
Use of health care services
Description
Piloted form assessing doctor visits, procedures, medication use, missed days of work
Time Frame
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Title
Physical Activity Level
Description
Godin Leisure Time Physical Activity Questionnaire
Time Frame
Baseline, post intervention, 2 and 4 month follow up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Community-dwelling, English-speaking women, over 18 years, who are currently undergoing chemotherapy for Stage 1-3 BC and have been cleared by their oncologist to participate in moderate intensity aerobic exercise Exclusion Criteria: Participants will be excluded from the study if they have another chronic disease, cognitive impairment or injury that prevents them from participating independently in moderate intensity exercise
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jenna Smith-Turchyn, PT, PhD(c)
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McMaster University
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S1C7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31168711
Citation
Smith-Turchyn J, Richardson J, Tozer R, McNeely M, Thabane L. Bridging the gap: incorporating exercise evidence into clinical practice in breast cancer care. Support Care Cancer. 2020 Feb;28(2):897-905. doi: 10.1007/s00520-019-04897-9. Epub 2019 Jun 5.
Results Reference
derived

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Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario

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