A Pilot Randomized Controlled Trial of a Virtual Peer-support Exercise Intervention for Older Adults with Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Recruitment rate
研究概览
简要总结
Background:
By 2030, 23% of Canadians will be over 65 years of age. Two in five of these individuals will be diagnosed with cancer. Older adults have high levels of functional decline, and a cancer diagnosis adds prolonged physical sequelae to the natural aging process. Many of these effects can be mitigated by regular exercise. However, older adult cancer survivors are significantly less likely to meet current exercise guidelines than their younger counterparts. As our population ages, we need to develop effective, scalable interventions that support health in older adult cancer survivors. The objective of this study is to determine the feasibility and preliminary effectiveness of a virtually delivered peer exercise intervention with qualified exercise professional (QEP) support for older adult cancer survivors.
Methods:
Participants will include older adult cancer survivors who are cleared for exercise, have consistent access to the internet, and currently take part in less than 150 minutes of exercise per week. All participants will be matched with a partner, given a peer support guide, and information on current exercise guidelines. In addition to being matched with a peer, dyads in the intervention group will have weekly virtual sessions with a QEP for 10 weeks. Participants in the control group will independently support their partner around exercise for 10 weeks.
Outcomes:
Participants will be assessed at 3 time points. The primary outcome is feasibility. This will be measured by assessing recruitment, retention, adherence rates to the intervention, and participant acceptability and satisfaction. Secondary effectiveness outcomes include exercise volume, social support, quality of life, physical function, and physical activity enjoyment.
Impact:
If effective, this will be the first virtual peer-based exercise intervention for older adult cancer survivors. Findings will inform future methods aimed at increasing exercise in older adults.
详细描述
METHODS
Research Questions:
Research Question 1 (primary). Is a virtually-delivered, peer matching exercise intervention supported by qualified exercise professionals (QEP) feasible for older adult cancer survivors? Research Question 2. Do older adult cancer survivors who participate in a virtually-delivered peer matching exercise intervention with QEP support have improved levels of social support compared to those matched with a peer only? Research Question 3. Do older adult cancer survivors who participate in a virtually-delivered peer matching exercise intervention with QEP support have improved levels of physical activity behaviour, health-related quality of life and physical functioning compared to those who are matched with a peer only?
Study Design:
This is a two-arm pilot randomized controlled trial with blinded outcome assessment. The protocol and study methods adhere to the CONSORT extension for randomized pilot trials. The Hamilton Integrated Research Ethics Board will approve this study. Dyads will be randomized (1:1) to the Intervention (AgeMatchPLUS) or control (AgeMatch) groups prior to baseline assessment. Group allocation will be centrally randomized using a web platform (https://www.randomizer.org/) by a graduate student external to the research team. A Research Assistant will assign group allocation in the order participants complete an initial demographics questionnaire and are matched with a peer for the study.
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
- Double (Investigator, 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
- •English speaking
- •Older adult (>60 years)
- •Living with or beyond a cancer diagnosis (any type or stage of cancer at any stage of treatment)
- •Living in Canada
- •Medically cleared for exercise
- •Have consistent access to an internet-connected device with webcam
- •Currently take part in less than 150 minutes of MVPA per week
排除标准
- •Self-report any contraindications to exercise
- •Had recent (in the last 4 weeks) or have planned surgery of any kind (including reconstructive surgery) in the next 3 months.
结局指标
主要结局
Recruitment rate
时间窗: 10 weeks
The percentage of eligible individuals who expressed interest in the study that enrolled
Participant Satisfaction
时间窗: 10 weeks
7 points Likert satisfaction scale
Retention rate
时间窗: 10 weeks
The percentage of enrolled participants who completed the intervention
Adherence rate
时间窗: 10 weeks
The percentage of total sessions attended and tracked using weekly logs
次要结局
- Health-related quality of life(14 weeks)
- Sub-max aerobic Capacity(14 weeks)
- Physical functioning(14 weeks)
- Enjoyment of performing physical activity(14 weeks)
- Self-report physical functioning(14 weeks)
- Social support(14 weeks)
- Sub-max aerobic capacity(10 weeks)
- Exercise volume(14 weeks)