Recruiting

CaRE-4-alloBMT

Sponsor:

Jennifer Jones

Code:

NCT07457866

Conditions

Allogenic Bone Marrow Transplantation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CaRE-4-alloBMT

Study Details

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

Study ID

NCT07457866

Start date

Oct 1, 2025

Status verified date

Mar, 2026

Completion date

Aug 30, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

• 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

208 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: CaRE-4-alloBMT intervention arm

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)

no intervention: Usual Care

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

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)

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jennifer M Jones, PhD

14165818603Jennifer.jones@uhn.ca

Charmaine A Silva, MSc

4165818453charmaine.silva@uhn.ca

Locations

Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Contacts

Jennifer Jones, PhD

14165818603Jennifer.jones@uhn.ca

Charmaine Silva, MSc

4165818453charmaine.silva@uhn.ca

Principal Investigator:

Jennifer M Jones, PhD

More Information

Sponsor

Jennifer Jones

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Keywords

  • allogenic bone marrow
  • rehabilitation
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jennifer Jones on 2026-03-09.