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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
85
Exercise component: Aerobic exercise, using recumbent bikes, delivered within the cancer institution. Participants will take part in up to 30-minutes of moderate intensity (50-70% HRmax or 4-6/10 on Rate of Perceived Exertion scale)6 exercise for eight sessions during chemotherapy. An exercise specialist with experience in cancer rehabilitation will supervise the exercise component.
Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines
Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Change in baseline physical activity level
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).
Time frame: 16-weeks, 6-months, 12-months
Change in baseline quality of life
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).
Time frame: 16-weeks, 6-months, 12-months
Change in level of exercise knowledge
Measured using the Theory of Planned Behaviour (TPB) based questionnaire (scale range 7-56; higher scores indicate higher levels of exercise knowledge).
Time frame: 16-weeks, 6-months, 12-months
Change in baseline perception of health status
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)
Time frame: 16-weeks, 6-months, 12-months
Change in baseline aerobic capacity
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)
Time frame: 16-weeks, 6-months, 12-months
Change in baseline levels of lower extremity strength
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).
Time frame: 16-weeks, 6-months, 12-months
Change in patient engagement in health services
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).
Time frame: 16-weeks, 6-months, 12-months
Change in baseline levels of resting BP
To measure change in cardiovascular outcomes; Measured with sphygmamometer
Time frame: 16-weeks, 6-months, 12-months
Change in baseline resting heart rate
To measure change in cardiovascular outcomes; Measured with pulsed oximeter
Time frame: 16-weeks, 6-months, 12-months
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