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Completed

NCT Number: NCT03087461

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S1C7, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise and self-management

Behavioral

The intervention will include aerobic exercise and self-management education using technology.

Primary outcomes

  1. Study Recruitment Rate: percentage of eligible patients recruited

    Time frame: Baseline

    A recruitment log will be kept, detailing reasons for non-participation.

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

  5. 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

  6. Physical Activity Level

    Time frame: Baseline, post intervention, 2 and 4 month follow up

    Godin Leisure Time Physical Activity Questionnaire

Sponsors and collaborators

Lead sponsor

Hamilton Health Sciences Corporation

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Mar 22, 2017
Registry last updated
Feb 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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