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临床试验/NCT04966156
NCT04966156已完成不适用

A Longitudinal Multidimensional Cancer Rehab Program for Patients Undergoing Allogenic Bone and Marrow Transplantation (CaRE-4-alloBMT)

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年9月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
80
试验地点
1
主要终点
Drop-out rates as a measure of feasibility

研究概览

简要总结

Currently, transplantation centers across North America generally do not offer longitudinal rehabilitation programs and research is urgently needed to test the acceptability and effectiveness of these programs using innovative delivery strategies that have the potential for future scalability and to understand the associated costs. Through a strong collaboration between the PM Cancer Rehabilitation and Survivorship (CRS) and alloBMT teams, the principal investigators developed an innovative multicomponent rehabilitation intervention for patients undergoing alloBMT (CaRE-4-alloBMT).

CaRE-4-alloBMT uses a person- centred strategy and a multidimensional approach targeting physical activity, nutrition, psychosocial distress and promoting self-management skills. Innovative components of CaRE-4-alloBMT include:1) Individualized progressive exercise prescriptions developed and monitored by CRS registered kinesiologists and supported with a web/mobile application (Physitrack) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials; 2) Individualized nutrition plans and stepped stratified care (education, counselling, intervention) based on nutritional status and delivered by registered dietitians (alloBMT and CRS). 3) On-line e-modules (developed in collaboration with PM Oncology Education) provide interactive education to promote self-management skills on crucial topics; 4) Remote monitoring using FitbitTM devices to monitor patients physical activity, caloric intake, and sleep for duration of the program; 5) Remote clinical support: Pre/Post discharge, patients will have scheduled (PHS) remote check-ins and health coaching sessions with a member of the CRS team (phone or MS Teams video).

Objectives: i) To test the feasibility and safety of CaRE-4-alloBMT plus standard best practice cancer care compared to standard best practice cancer care alone; ii) To assess the preliminary efficacy of CaRE-4-alloBMT on physical function, disability, nutritional status, distress, QoL, healthcare utilization, and survival and estimate program return on investment.

详细描述

1.0 BACKGROUND: Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for many hematologic cancers and its use has increased rapidly over the past decade. While effective, alloBMT is associated with numerous treatment-related physical and psychosocial side effects, reduced physical functioning, and worsening nutritional status which are associated with increased risk of complications (i.e. infections, drug toxicity, weight loss, graft failure & graft-versus-host disease), significant early and late treatment related mortality, and can profoundly affect quality of life (QoL).

As a result, there have been calls for increased attention to the management of adverse effects associated with alloBMT with the goal to minimize dysfunction, maximize well-being and QoL, and reduce treatment-related mortality.

Cancer rehabilitation is now considered an essential component of cancer care and focuses on prevention and treatment of the adverse effects of cancer and treatment and to optimize functional status and QoL. Embedding multidimensional longitudinal (pre to post transplant) rehabilitation programs that focus on exercise, nutrition and teaching self-management skills as a standard part of treatment for individuals undergoing alloBMT has potential to mediate the significant adverse effects, improve survival, and reduce burden on the healthcare system. While patients typically receive some in-patient rehabilitation, this is a small part of the alloBMT pathway and services are quite limited. Currently, transplantation centers across North America generally do not offer longitudinal rehabilitation programs and research is urgently needed to test the acceptability and effectiveness of these programs using innovative delivery strategies that have the potential for future scalability and to understand the associated costs. In response, through a strong collaboration between the PM Cancer Rehabilitation and Survivorship (CRS) and alloBMT teams, the principal investigators developed an innovative multicomponent rehabilitation intervention for patients undergoing alloBMT (CaRE-4-alloBMT).

2.0 PROGRAM DESCRIPTION (see Appendix 1): CaRE-4-alloBMT is a longitudinal 6-month rehabilitation program (peri to post transplant) adapted from an existing evidence-based and effective model developed by the CRS team (CaRE@ELLICSR and CaRE@Home). The program is informed by established behaviour change theory and harnesses current and emerging eHealth technologies to reduce barriers to accessing and providing cancer rehabilitation. CaRE-4-alloBMT uses a person- centred strategy and a multidimensional approach targeting physical activity, nutrition, psychosocial distress and promoting self-management skills. Innovative components of CaRE-4-alloBMT include:

  1. Individualized progressive exercise prescriptions developed and monitored by CRS registered kinesiologists and supported with a web/mobile application (Physitrack) that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials. The initial personalized exercise program will be given to a participant following the initial assessment. A program will be created based on the specific needs and physical condition of each participant. The participant will receive the detailed exercise program via Physitrack (includes exercise description and videos of each exercise). Each exercise program will contain cardiovascular and strength training as well as stretching exercises. The exercise program will be revised and progressions will be added based on the individual's needs after the follow-up assessments or during the scheduled check-ins between assessments. Check-ins are scheduled as follows:

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 (Participant)

盲法说明

biostatician will provide the randomized grouping for each of the participants.

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

  • •18 years of age or older
  • •Must have received a hematologic cancer diagnosis
  • •Awaiting alloBMT
  • •Able to communicate in English
  • •Able to access online study material (Physitrack and education e-modules).

排除标准

  • •Not meeting the inclusion criteria

研究组 & 干预措施

Usual care group

No Intervention

No change to patient's usual care at Princess Margaret Cancer Centre.

CaRE-4-allBMT plus usual care

Experimental

a longitudinal 6-month rehabilitation program that uses a person- centred strategy and a multidimensional approach targeting physical activity, nutrition, psychosocial distress and promoting self-management skills.

干预措施: CaRE-4-alloBMT plus usual care group (Behavioral)

结局指标

主要结局

Drop-out rates as a measure of feasibility

时间窗: 6 months

Number of patients who complete the study/ drop-out will be used to identify feasibility of the intervenion.

Patient preference as assessed during clinical support as a measure of feasibiity

时间窗: 6 months

Check-ins with health coach during assessments will be used to identify intervention acceptability/preference.

Measuring safety as assessed during one-on-one interviews with health coach - this wll be (analyzed as qualitative data) done over MS Teams and will be a conversational question and answer format.

时间窗: 6 months

Patients will be checking-in at specific timepoints with a health coach to discuss their preference/challenges with intervention.

次要结局

  • Measure of the level of healthcare utilization by patient(6 months)
  • measure of overall survival(6 months)
  • Euroqol 5D(6 months)
  • 36 items short form health survey(6 months)
  • Evaluating nutritional status based on caloric intake(6 months)
  • Using the Body Mass Indext to measure nutritional status(6 months)
  • Disability assessment schedule(6 months)
  • Measure of nutritional status by using the Patient Generated Subjective Global Assessment(6 months)
  • General Anxiety Disorder assessment(6 months)
  • Functional Assessment of Cancer Therapy for Bone Marrow Transplant(6 months)
  • 6 minute walk test(6 months)
  • grip strength tests(6 months)
  • Sit-to-stand test(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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