Rehab Study for alloBMT Patients

Официальное название

A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)

Обзор

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.

Вмешательства

• Поведенческое CaRE-4-alloBMT
  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 progres

Первичные конечные точки

• 36-Item Short Form Health Survey questionnaire (SF-36) [Срок оценки: 3 months post-discharge]

Вторичные конечные точки (9)

• Initial hospital stay Transplant outcomes [Срок оценки: Year 4]
• Number of readmission Transplant outcomes [Срок оценки: Year 4]
• Number of days in hospital Transplant outcomes [Срок оценки: Year 4]
• Overall survival Transplant outcomes [Срок оценки: At year 4]
• EQ 5D 5L [Срок оценки: 9 months]
• Modified Patient-Generated Subjective Global Assessment [Срок оценки: 9 months]
• Hospital Anxiety and Depression Scale (HADS) [Срок оценки: 9 months]
• 12-item World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0) [Срок оценки: 9 months]
• Demographic and clinical information [Срок оценки: A one-time questionnaire to be completed at baseline/prior to initial assessment.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Princess Margaret Cancer Centre — Toronto

Идентификаторы

NCT: NCT07457866 · 24-5483

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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