Bridging the Gap: Incorporating Exercise Evidence Into Clinical Practice in Breast Cancer Care in Ontario
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Study Recruitment Rate: percentage of eligible patients recruited
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention Group
The intervention group will receive a multi-component KT intervention. This will include exercise and self-management components.
The exercise intervention will involve a moderate intensity aerobic exercise program, using recumbent bikes, delivered within the cancer institution. Participants will take part in the 30-minute sessions 8 times. The intervention will be supervised by a physiotherapist (PT) educated in cancer rehabilitation.
The SM component will include educational modules created by a PT. Participants will view these 30 minute modules prior to each exercise intervention, over the same 8 sessions.
干预措施: Exercise and self-management (Behavioral)
Usual Care
Control group receiving usual care (no exercise or self-management education within the institution).
结局指标
主要结局
Study Recruitment Rate: percentage of eligible patients recruited
时间窗: Baseline
A recruitment log will be kept, detailing reasons for non-participation.
Intervention Retention Rate: percentage of consented participants who completed the intervention
时间窗: 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
时间窗: 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
次要结局
- Health status(Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion))
- Exercise knowledge(Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion))
- Exercise behaviour(Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion))
- Use of health care services(Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion))
- Physical Activity Level(Baseline, post intervention, 2 and 4 month follow up)
- Health related quality of life(Baseline, post intervention (2 months post baseline), 2 and 4 month follow up (post intervention completion))
研究者
Jenna Smith
PhD Candidate
Hamilton Health Sciences Corporation