Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:57 AM
Study NCT ID:
NCT07457866
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rehab Study for alloBMT Patients
Sponsor:
Jennifer Jones
Organization:
Study Overview
Official Title:
A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)
Status:
RECRUITING
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CaRE-4-alloBMT
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: