Ignite Creation Date:
2025-12-24 @ 12:36 PM
Ignite Modification Date:
2026-02-10 @ 3:26 AM
Study NCT ID:
NCT03087461
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2017-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
Sponsor:
Hamilton Health Sciences Corporation
Organization:
Study Overview
Official Title:
Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: