Clinical trial NCT03087461: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
First posted: 2017-03-22
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Study Recruitment Rate: percentage of eligible patients recruited
timeFrame: Baseline
measure: Intervention Retention Rate: percentage of consented participants who completed the intervention
timeFrame: Post-intervention (2 months post baseline)
measure: Intervention Adherence Rate: percentage of total intervention sessions attended
timeFrame: Post-intervention (2 months post baseline)
Secondary outcomes:
measure: Health related quality of life
timeFrame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
measure: Exercise knowledge
timeFrame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
measure: Exercise behaviour
timeFrame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
measure: Health status
timeFrame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
measure: Use of health care services
timeFrame: Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion)
measure: Physical Activity Level
timeFrame: Baseline, post intervention, 2 and 4 month follow up
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Jenna Smith-Turchyn, PT, PhD(c)
role: PRINCIPAL_INVESTIGATOR
References:
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.