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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03087461
• Other study ID #: HamiltonHSC-JS
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: October 1, 2018

Study information

• Verified date: February 2019
• Source: Hamilton Health Sciences Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Exercise and self-management
The intervention will include aerobic exercise and self-management education using technology.

Locations

Country	Name	City	State
Canada	McMaster University	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Recruitment Rate: percentage of eligible patients recruited	A recruitment log will be kept, detailing reasons for non-participation.	Baseline
Primary	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	Post-intervention (2 months post baseline)
Primary	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	Post-intervention (2 months post baseline)
Secondary	Health related quality of life	Functional Assessment of Cancer Therapy-Breast	Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Secondary	Exercise knowledge	Theory of planned behaviour questionnaire	Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Secondary	Exercise behaviour	Theory of planned behaviour questionnaire	Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Secondary	Health status	European Quality of Life-Five Dimension (EQ-5D)	Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
Secondary	Use of health care services	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)
Secondary	Physical Activity Level	Godin Leisure Time Physical Activity Questionnaire	Baseline, post intervention, 2 and 4 month follow up