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

February 20, 2019 updated by: Jenna Smith, Hamilton Health Sciences Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

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 Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8S1C7
        • McMaster University

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group

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.
Behavioral: Exercise and self-management
The intervention will include aerobic exercise and self-management education using technology.
No Intervention: Usual Care
Control group receiving usual care (no exercise or self-management education within the institution).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Recruitment Rate: percentage of eligible patients recruited
Time Frame: Baseline
A recruitment log will be kept, detailing reasons for non-participation.
Baseline
Intervention Retention Rate: percentage of consented participants who completed the intervention
Time Frame: Post-intervention (2 months post baseline)
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
Post-intervention (2 months post baseline)
Intervention Adherence Rate: percentage of total intervention sessions attended
Time Frame: Post-intervention (2 months post baseline)
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
Post-intervention (2 months post baseline)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health related quality of life
Time Frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Functional Assessment of Cancer Therapy-Breast
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise knowledge
Time Frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Theory of planned behaviour questionnaire
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Exercise behaviour
Time Frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Theory of planned behaviour questionnaire
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Health status
Time Frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
European Quality of Life-Five Dimension (EQ-5D)
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Use of health care services
Time Frame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Piloted form assessing doctor visits, procedures, medication use, missed days of work
Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Physical Activity Level
Time Frame: Baseline, post intervention, 2 and 4 month follow up
Godin Leisure Time Physical Activity Questionnaire
Baseline, post intervention, 2 and 4 month follow up

Collaborators and Investigators

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

Sponsor

Hamilton Health Sciences Corporation

Investigators

  • Principal Investigator: Jenna Smith-Turchyn, PT, PhD(c), McMaster University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2017

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

March 7, 2017

First Submitted That Met QC Criteria

March 16, 2017

First Posted (Actual)

March 22, 2017

Study Record Updates

Last Update Posted (Actual)

February 22, 2019

Last Update Submitted That Met QC Criteria

February 20, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HamiltonHSC-JS

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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