Breast Cancer
Conditions
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.
Interventions
BEHAVIORALExercise and self-management
The intervention will include aerobic exercise and self-management education using technology.
Sponsors
Hamilton Health Sciences Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Study Recruitment Rate: percentage of eligible patients recruited | Baseline | A recruitment log will be kept, detailing reasons for non-participation. |
| Intervention Retention Rate: percentage of consented participants who completed the intervention | 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 |
| Intervention Adherence Rate: percentage of total intervention sessions attended | 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
| Measure | Time frame | Description |
|---|---|---|
| Health status | Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion) | European Quality of Life-Five Dimension (EQ-5D) |
| Health related quality of life | Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion) | Functional Assessment of Cancer Therapy-Breast |
| Physical Activity Level | Baseline, post intervention, 2 and 4 month follow up | Godin Leisure Time Physical Activity Questionnaire |
| Use of health care services | 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 |
| Exercise knowledge | Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion) | Theory of planned behaviour questionnaire |
| Exercise behaviour | Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion) | Theory of planned behaviour questionnaire |
Countries
Canada
Outcome results
None listed