Participating in Tai Chi to Reduce Anxiety and Keep up Physical Function: Implementing a Prehabilitation Intervention for Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participant recruitment rate
研究概览
简要总结
The goal of the proposed project is to test the implementation strategy, in terms of feasibility and utility, of an online Tai Chi intervention as a prehabilitation model to prepare prostate cancer patients and their caregivers for radical prostatectomy (RP). The investigators' hypothesis is that, by using an online teaching module, the proposed prehabilitation model is feasible on the prostate cancer care pathway in a simple, efficient, and minimally disruptive manner. In addition, participating in the Tai Chi intervention will improve patient anxiety leading up to the RP and improve physical function as well as post-operative side-effects associated with RP.
Our primary objective is to test the feasibility of the implementation strategy from multi-stakeholder perspectives. The investigators will use mixed-methods to assess the barriers and facilitators related to implementing the online Tai Chi intervention from multi-stakeholder perspectives guided by the Consolidated Framework for Implementation Research.
Our secondary objective is to examine the effect of the Tai Chi intervention on patient outcomes at peri-RP and post-RP. The investigators will quantitatively test the effect of the intervention to reduce peri- and post-RP anxiety and improve peri- and post-RP physical function and general disease specific patient-reported outcomes.
An exploratory objective is to explore the effect of the Tai Chi intervention on surgical outcomes. The study team will quantitatively describe the difference in post-RP surgical outcomes between the intervention and control groups.
详细描述
The goal of the proposed project is to test the implementation strategy, in terms of feasibility and utility, of an online Tai Chi intervention as a prehabilitation model to prepare prostate cancer patients and their caregivers for radical prostatectomy (RP).
The investigators primary objective is to test the feasibility of the implementation strategy from multi-stakeholder perspectives. The study team will use mixed-methods to assess the barriers and facilitators related to implementing the online Tai Chi intervention from multi-stakeholder perspectives guided by the Consolidated Framework for Implementation Research.
The investigators secondary objective is to examine the effect of the Tai Chi intervention on patient-reported outcomes at peri-RP and post-RP. The study team will quantitatively test the effect of the intervention to reduce peri- and post-RP anxiety and improve peri- and post-RP physical function and general disease specific patient-reported outcomes.
The tertiary objective is to explore the effect of the Tai Chi intervention on surgical outcomes. We will quantitatively test the effect of the intervention in improving post-RP surgical outcomes.
Study Design and Methods:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Although it is not possible to blind participants or interventionists to group allocation, the random allocation sequence will be blinded from study staff conducting data management and analyses. The randomization schedule, generated by the project data analyst, will be kept by project staff who will deliver it, in a sealed envelope, to a research assistant who will then assign qualified individuals to intervention groups. Randomization will occur after informed consent is obtained and baseline assessments have been completed. Participants will be notified of their allocation through phone calls.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Must speak English.
- •Scheduled and awaiting radical prostatectomy for prostate cancer
- •Not previously treated for prostate cancer, including radiation therapy to the pelvis, major pelvic surgery, or placement of a penile implant or artificial urinary sphincter
- •No known urethral stricture or colostomy or chronic urinary catheterization
- •No medical or current psychiatric disorders that precludes their participation in the
- •Permission to exercise from their primary physicians
- •Not currently practicing Tai Chi or related activities that involve mindfulness practice
- •Has access to a computer or tablet, reliable internet and the skills/knowledge to use email, complete online questionnaire and attend Zoom meetings.
研究组 & 干预措施
Tai Chi Prehabilitation
8 weeks Tai Chi prehabilitation prior to radical prostatectomy
干预措施: Tai Chi Prehabilitation (Other)
Usual Care
Usual care
干预措施: Usual care (Other)
结局指标
主要结局
Participant recruitment rate
时间窗: 8 weeks
Evaluate the percentage of patients willing to participate in the intervention among eligible patients approached
Adverse events
时间窗: 8 weeks
Will record all adverse events that occur over the course of the intervention, if applicable.
Intervention uptake ratio
时间窗: 8 weeks
A ratio of the number of participants who actively participated in the intervention against the total number of participants in the intervention group will be assessed.
Intervention barriers and facilitators
时间窗: 8 weeks
Qualitative data collection and interview guide development will follow the CFIR methodology to assess the intervention barriers and facilitators under five domains: intervention characteristics (key attributes of interventions), outer setting (factors outside the implementation organization), inner setting (factors within the implementation organization), characteristics of the individuals involved (perceptions, attitudes, and motivation of individuals), and the process (strategies to support implementation)
Adherence to intervention
时间窗: 8 weeks
Calculate percentage of intervention completions based on the numbers of attended sessions and the duration of attendance
Reasons for withdrawal
时间窗: 8 weeks
Will record reasons for withdrawal for those participants that withdraw from the study, when applicable.
次要结局
- Short Form-36 (SF-36)(5 months)
- General Anxiety Disorder 7-item Scale (GAD-7)(5 months)
- Pittsburgh Sleep Quality Inventory (PSQI)(5 months)
- Patient Health Questionnaire (PHQ-9)(5 months)
- Brief Pain Inventory (BPI)(5 months)
- Physical function(5 months)
- Expanded Prostate Cancer Index Composite (EPIC)(5 months)
研究者
Lin Yang
Research Scientist
AHS Cancer Control Alberta