Implementing Exercise Into Clinical Practice in Breast Cancer Care

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Exercise; Behavioral: Self-Management; Behavioral: Booster Sessions

• Registration Number: NCT04109274
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

BACKGROUND:

One in eight women will develop breast cancer in their lifetime. With improved screening and treatment techniques, more women are surviving breast cancer. However, women live with physical and emotional side effects secondary to treatment for years after cancer treatments have ended. Exercise can help to manage these side effects, however, less than 30% of this population takes part in regular exercise. The objective of this trial is to determine the feasibility and effectiveness of a novel exercise and education program for women with breast cancer during chemotherapy.

METHODS:

Participants in this study include women with a diagnosis of stage 1 - 3 breast cancer undergoing chemotherapy. Women will be divided into three groups. The first group will include 8 sessions of exercise and self-management education during their chemotherapy treatment. The second group will receive self-management education only, and the third group will receive usual care. Outcomes will be compared between groups at baseline, post-intervention, and at 6- and 12- month follow up. Outcomes to be assessed include exercise level, functional mobility, muscle strength, quality of life, health status, and use of health care services.

EXPECTED OUTCOMES:

Women with breast cancer are among the least active segment of the Canadian population. It is well known that inactivity can lead to physical and psychological side effects, cancer recurrence, and an increase in comorbid conditions. This proposed project addresses a long-standing need to help women with breast cancer become and stay more active by implementing a novel exercise and education program.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-05
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-30
• Study Start: 2019-10-03
• Primary Completion: 2024-02-29
• Study Completion: 2024-02-29
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

• community-dwelling
• English-speaking women
• over 18 years of age
• currently undergoing adjuvant or neoadjuvant chemotherapy for Stage 1-3 breast cancer
• cleared by their oncologist to participate in moderate intensity aerobic exercise

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Exclusion Criteria

• self-report any chronic condition, cognitive impairment, or injury that would prevent them from participating independently in moderate intensity exercise

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Institution-Based Exercise and Self-Management (EXSM)	Exercise	Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Institution-Based Exercise and Self-Management (EXSM)	Booster Sessions	Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Institution-Based Self-management only (SM)	Self-Management	Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.
Institution-Based Exercise and Self-Management (EXSM)	Self-Management	Eight session of supervised exercise within the cancer institution plus 8 self-management modules focusing on goal setting and action planning for safe and effective exercise strategies (this is based on our team's successful pilot intervention). Four booster sessions will be provided to this group.
Institution-Based Self-management only (SM)	Booster Sessions	Eight SM sessions for safe and effective exercise strategies will be provided to this group (described above). Four booster sessions will be provided to this group.

Primary Outcome Measures

Name	Time	Method
Change in baseline physical activity level	16-weeks, 6-months, 12-months	To be assessed using the Godin Leisure Time Exercise Questionnaire (total score 0-no maximum; higher scores indicating higher levels of physical activity) and activity tracker (Fitbit) data (demonstrating steps/day and total time of moderate levels of physical activity; higher scores indicate higher levels of activity).

Secondary Outcome Measures

Name	Time	Method
Change in level of exercise knowledge	16-weeks, 6-months, 12-months	Measured using the Theory of Planned Behaviour (TPB) based questionnaire (scale range 7-56; higher scores indicate higher levels of exercise knowledge).
Change in baseline quality of life	16-weeks, 6-months, 12-months	Measured using the Functional Assessment of Cancer Therapy-Breast (measure of quality of life in breast cancer survivors; scale range 0-144; higher scores indicate higher levels of quality of life).
Change in baseline perception of health status	16-weeks, 6-months, 12-months	Measured using the EQ-5D-3L a measure of health status (has two systems; a 3 level scale assessing five dimensions of health and a visual analogue scale from 0-10; higher scores indicate higher perceptions of health status)
Change in baseline aerobic capacity	16-weeks, 6-months, 12-months	Measured using the Six-minute walk test (6MWT) (a performance based measure that assesses total distance walked in six minutes, higher scores indicate higher levels of aerobic capacity)
Change in baseline levels of lower extremity strength	16-weeks, 6-months, 12-months	Measured using a manual muscle dynamometer (Movements assessed will be isometric hip and knee flexion/extension and ankle plantar flexion/dorsiflexion; higher scores indicate higher levels of lower extremity strength).
Change in patient engagement in health services	16-weeks, 6-months, 12-months	Measured using the Patient Health Engagement Scale (assesses five domains related to the experiences and preferences of patients for their engagement with their health care treatment; score range from 5-35; higher scores indicate higher levels of patient engagement in health services).
Change in baseline levels of resting BP	16-weeks, 6-months, 12-months	To measure change in cardiovascular outcomes; Measured with sphygmamometer
Change in baseline resting heart rate	16-weeks, 6-months, 12-months	To measure change in cardiovascular outcomes; Measured with pulsed oximeter

Trial Locations

Locations (1)

Juravinski Cancer Centre; 🇨🇦 Hamilton, Ontario, Canada