A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- 36-Item Short Form Health Survey questionnaire (SF-36)
研究概览
简要总结
The goals of this phase III clinical trial is to determine effectiveness in the setting where it will be implemented as well as to gain an understanding of the context for implementation. Effectiveness of CaRE-4-alloBMT will be assessed using a parallel two-arm pragmatic randomized controlled trial (pRCT). Pragmatic trials are undertaken in "real world" settings and place a greater emphasis on external validity and generalizability to support the decision on whether to deliver an intervention.
Participants will:
- Complete a questionnaire package and an initial assessment with a registered Kinesilogist
- Randomized into either the CaRE-4-alloBMT (Intervention group) or the Usual Care group.
- Complete the patient reported outcome measures and physiological assessments at baseline (T0), hospital admission (T1), hospital discharge (T2), 3-months post-discharge (T3), and 6 months post-discharge (T4).
Usual Care (UC). The UC group will receive standard cancer care provided to all patients undergoing alloBMT at Princeess Margaret, including the provision of self-directed online resources and a booklet-based physiotherapy program outlining the role of exercise and examples of exercises that can be done at the hospital and at home during recovery. At admission, patients undergo a nutrition assessment by the alloBMT dietician and are provided a caloric intake goal. They are asked to track their food intake through a food journal that is monitored by the alloBMT dietitian. When needed, as determined by the alloBMT team, patients are given access to supportive care services including psychosocial oncology and in-patient and outpatient rehabilitation.
CaRE-4-alloBMT (Intervention, INT): Patients randomized to the intervention arm will receive usual care plus the CaRE-4-alloBMT intervention. The CaRE-4-alloBMT program is delivered from 4-8 weeks pre-transplant through to 6 months post-transplant (estimated at 8-9 months total). It uses a person-centered strategy and a multidimensional approach targeting physical activity and promoting self-management skills to enhance nutrition, psychosocial functioning and to help manage common side effects.
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
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled to undergo alloBMT and are:
- •> 18 years of age;
- •receiving treatment for a hematologic cancer;
- •completing pre- and post-transplant care at PM;
- •able to access on-line study material; and
- •able to understand (spoken and written) English. Participants receiving a second transplant at the time of screening will be included if they meet the above criteria.
排除标准
- •scheduled to be admitted to the hospital for their alloBMT < 2 weeks from the initial assessment booking, as this will not allow enough time for the prehabilitation phase of the study;
- •are participating in any other clinical trials or supportive care intervention studies; or
- •have comorbidities or musculoskeletal complications that preclude participation in the exercise programs.
研究组 & 干预措施
CaRE-4-alloBMT intervention arm
The program is informed by established behaviour change theory, including motivational interviewing (MI), theory of planned behaviour, self-efficacy, and the model of supportive accountability, and has a number of embedded behaviour change techniques, which are known to increase effectiveness. The program also harnesses current and emerging eHealth technologies to overcome barriers to accessing and providing cancer rehabilitation. Key components of the intervention are:
1) Individualized progressive exercise prescriptions; 2) Remote monitoring of heart rate, sleep and weight with Fitbit devices; 3) Self-management skills teaching (online modules on topics such as exercise, eat and cook for wellness, mindfulness, fatigue, brain health, etc); 4) Person-to-person clinical support (remote check-in calls with a kinesiologist)
干预措施: CaRE-4-alloBMT (Behavioral)
Usual Care
The UC group will receive standard cancer care provided to all patients undergoing alloBMT at PM, including the provision of self-directed online resources and a booklet-based physiotherapy program outlining the role of exercise and examples of exercises that can be done at the hospital and at home during recovery. At admission, patients undergo a nutrition assessment by the alloBMT dietician and are provided a caloric intake goal. They are asked to track their food intake through a food journal that is monitored by the alloBMT dietitian. When needed, as determined by the alloBMT team, patients are given access to supportive care services including psychosocial oncology and in-patient and outpatient rehabilitation.
结局指标
主要结局
36-Item Short Form Health Survey questionnaire (SF-36)
时间窗: 3 months post-discharge
The SF-36 is a measure of health status and consists of 36 questions that cover eight health domains and two summary scales: the physical component summary (PSC) and the mental component (MSC). For this project the PCS was chosen as the primary outcome. The minimum score value is a zero and represents the lowest level of health, maximum disability or severe pain. The maximum score is 100 and represents the highest value of health, no disability or no pain.
次要结局
- Initial hospital stay Transplant outcomes(Year 4)
- Number of readmission Transplant outcomes(Year 4)
- Number of days in hospital Transplant outcomes(Year 4)
- Overall survival Transplant outcomes(At year 4)
- EQ 5D 5L(9 months)
- Modified Patient-Generated Subjective Global Assessment(9 months)
- Hospital Anxiety and Depression Scale (HADS)(9 months)
- 12-item World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)(9 months)
- Demographic and clinical information(A one-time questionnaire to be completed at baseline/prior to initial assessment.)
研究者
Jennifer Jones
Director
University Health Network, Toronto