Rehab Study for alloBMT Patients

NCT07457866 | Recruiting

• 1 other identifier: 24-5483
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogenic Bone Marrow Transplantation

Keywords

allogenic bone marrow; rehabilitation; cancer

Outcome Measures

Primary Outcomes (1)

• 36-Item Short Form Health Survey questionnaire (SF-36)

  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.

  3 months post-discharge

Secondary Outcomes (9)

• 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

Study Arms (2)

CaRE-4-alloBMT intervention arm

EXPERIMENTAL

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)

Behavioral: CaRE-4-alloBMT

Usual Care

NO INTERVENTION

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.

Interventions

CaRE-4-alloBMT BEHAVIORAL

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)

CaRE-4-alloBMT intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jennifer Jones: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jennifer M Jones, PhD

  UHN Princess Margaret Cancer Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer M Jones, PhD

CONTACT

14165818603; Jennifer.jones@uhn.ca

Charmaine A Silva, MSc

CONTACT

4165818453; charmaine.silva@uhn.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: March 9, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): August 30, 2028
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

CA (1)