A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial

Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities. Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptabil...

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Published in:PloS one 2023-05, Vol.18 (5), p.e0285420
Main Authors: Tam, Samantha, Kumar, Rajat, Lopez, Paty, Mattsson, Jonas, Alibhai, Shabbir, Atenafu, Eshetu G, Bernstein, Lori J, Chang, Eugene, Clarke, Susan, Langelier, David, Lipton, Jeffrey, Mayo, Samantha, Papadakos, Tina, Jones, Jennifer Michelle
Format: Article
Language:English
Subjects:
Acceptability
Accountability
Activities of daily living
Allografts
Biology and Life Sciences
Blood
Bone Marrow
Bone marrow transplantation
CAI
Cancer
Cardiovascular disease
Care and treatment
Clinical trials
Clinical Trials, Phase II as Topic
Collaboration
Complications and side effects
Computer assisted instruction
Consent
Data collection
Exercise
Exercise Therapy - methods
Feasibility Studies
Frailty
Hematological diseases
Hematopoietic Stem Cell Transplantation
Humans
Intervention
Medicin och hälsovetenskap
Medicine and Health Sciences
Mortality
Patient outcomes
Patients
Physical fitness
Pilot Projects
Randomized Controlled Trials as Topic
Rehabilitation
Remote monitoring
Research and Analysis Methods
Stem cell transplantation
Study Protocol
Transplantation
Transplants & implants
Wearable computers
Wearable technology
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container_issue 5
container_start_page e0285420
container_title PloS one
container_volume 18
creator Tam, Samantha
Kumar, Rajat
Lopez, Paty
Mattsson, Jonas
Alibhai, Shabbir
Atenafu, Eshetu G
Bernstein, Lori J
Chang, Eugene
Clarke, Susan
Langelier, David
Lipton, Jeffrey
Mayo, Samantha
Papadakos, Tina
Jones, Jennifer Michelle
description Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities. Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptability and effectiveness of these programs. In response, we developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4-alloBMT). This study is a phase II randomized controlled trial (RCT) conducted at the Princess Margaret Cancer Centre in patients undergoing alloBMT. A total of 80 patients stratified by frailty score will be randomized to receive usual care (n = 40) or CaRE-4-alloBMT plus usual care (n = 40). The CaRE-4-alloBMT program includes individualized exercise prescriptions, access to online education through a dedicated self-management platform, wearable technology for remote monitoring, and remote tailored clinical support. Feasibility will be assessed by examining the recruitment and retention rates and adherence to the intervention. Safety events will be monitored. Acceptability of the intervention will be assessed through qualitative interviews. Secondary clinical outcomes will be collected through questionnaires and physiological assessments at baseline (T0, 2-6 weeks pre-transplant), transplant hospital admission (T1), hospital discharge (T2), and 3 months post-discharge (T3). This pilot RCT study will determine the feasibility and acceptability of the intervention and study design and will inform full-scale RCT planning.
doi_str_mv 10.1371/journal.pone.0285420
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Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptability and effectiveness of these programs. In response, we developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4-alloBMT). This study is a phase II randomized controlled trial (RCT) conducted at the Princess Margaret Cancer Centre in patients undergoing alloBMT. A total of 80 patients stratified by frailty score will be randomized to receive usual care (n = 40) or CaRE-4-alloBMT plus usual care (n = 40). The CaRE-4-alloBMT program includes individualized exercise prescriptions, access to online education through a dedicated self-management platform, wearable technology for remote monitoring, and remote tailored clinical support. Feasibility will be assessed by examining the recruitment and retention rates and adherence to the intervention. Safety events will be monitored. Acceptability of the intervention will be assessed through qualitative interviews. Secondary clinical outcomes will be collected through questionnaires and physiological assessments at baseline (T0, 2-6 weeks pre-transplant), transplant hospital admission (T1), hospital discharge (T2), and 3 months post-discharge (T3). This pilot RCT study will determine the feasibility and acceptability of the intervention and study design and will inform full-scale RCT planning.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>37192195</pmid><doi>10.1371/journal.pone.0285420</doi><orcidid>https://orcid.org/0000-0002-8670-8514</orcidid><orcidid>https://orcid.org/0000-0002-4613-3680</orcidid><orcidid>https://orcid.org/0000-0002-9863-5084</orcidid><oa>free_for_read</oa></addata></record>
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identifier ISSN: 1932-6203
ispartof PloS one, 2023-05, Vol.18 (5), p.e0285420
issn 1932-6203
1932-6203
language eng
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source Publicly Available Content Database (Proquest) (PQ_SDU_P3); PubMed Central
subjects Acceptability
Accountability
Activities of daily living
Allografts
Biology and Life Sciences
Blood
Bone Marrow
Bone marrow transplantation
CAI
Cancer
Cardiovascular disease
Care and treatment
Clinical trials
Clinical Trials, Phase II as Topic
Collaboration
Complications and side effects
Computer assisted instruction
Consent
Data collection
Exercise
Exercise Therapy - methods
Feasibility Studies
Frailty
Hematological diseases
Hematopoietic Stem Cell Transplantation
Humans
Intervention
Medicin och hälsovetenskap
Medicine and Health Sciences
Mortality
Patient outcomes
Patients
Physical fitness
Pilot Projects
Randomized Controlled Trials as Topic
Rehabilitation
Remote monitoring
Research and Analysis Methods
Stem cell transplantation
Study Protocol
Transplantation
Transplants & implants
Wearable computers
Wearable technology
title A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial
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