Allogenic Bone Marrow TransplantationCaRE-4-alloBMTNCT07457866
Rehab Study for alloBMT Patients
A study testing CaRE-4-alloBMT in people with Allogenic Bone Marrow Transplantation, run by Jennifer Jones at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Allogenic Bone Marrow Transplantation
- What is being tested?
- CaRE-4-alloBMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2025to 30 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
Jennifer Jones, PhD, 14165818603, Jennifer.jones@uhn.ca
Charmaine Silva, MSc, 4165818453, charmaine.silva@uhn.ca
About this study
Official title: A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)
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:
Read more
- 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
- Being tested
- CaRE-4-alloBMT
- Keywords
- allogenic bone marrow, rehabilitation, cancer
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaRE-4-alloBMTBehavioural
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-discharge
Secondary outcomes (9)
Initial hospital stay Transplant outcomes
Initial length of stay will be measured in days and will extracted from patient charts at the end of the study.
Measured: Year 4
Number of readmission Transplant outcomes
The number of readmissions per patient who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Measured: Year 4
Number of days in hospital Transplant outcomes
The total number of days spent in the hospital by patients who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Measured: Year 4
Overall survival Transplant outcomes
Overall survival (transplant-related mortality vs survival rates) patients who underwent alloBMT and participating in the study will extracted from patient charts at the end of the study.
Measured: At year 4
EQ 5D 5L
The instrument is a standardized descriptive system comprising five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each evaluated through a single item and measures quality of life. The maximum score of 1 represents having no problems in any of the 5 dimensions and best health while a minimum score of a negative value indicates worse health.
Measured: 9 months
Modified Patient-Generated Subjective Global Assessment
The instrument is a one-page tool that classifies patients into four nutritional levels, which are predictive of overall survival in cancer patients and measures nutritional status.
Measured: 9 months
Hospital Anxiety and Depression Scale (HADS)
This instrument includes 2 subscales designed to identify and quantify depression and anxiety in physically ill patients. The minimum score of zero and a maximum score of 21 where a higher score indicates higher distress.
Measured: 9 months
12-item World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
The instrument measures disability in accordance with the International Classification of Functioning, Disability, and Health. Participants rate their ability to perform 12 activities across six domains of functioning. A minimum score of zero indicates no disability and a maximum score of 48 indicates full disability.
Measured: 9 months
Demographic and clinical information
Demographic and clinical details will be collected from participants at the time of initial assessment via an intake questionnaire, including age, sex, gender, ethnicity, education level, socioeconomic status, and comorbidities.
Measured: A one-time questionnaire to be completed at baseline/prior to initial assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start1 Oct 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogenic Bone Marrow TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jennifer Jones
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor-investigator, Jennifer Jones, University Health Network, Toronto
- Investigators
- Jennifer M Jones, PhD, Principal investigator, UHN Princess Margaret Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07457866
- Sponsor's protocol ID
- 24-5483
- Acronym
- CaRE-4-alloBMT
- Status last verified
- Mar 2026
- First submitted
- 6 Feb 2026
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Type 1 Hybrid Effectiveness Implementation Trial of a Longitudinal Multidimensional Rehabilitation Program for Patients Undergoing Allogeneic Blood and Marrow Transplantation (CaRE4alloBMT)
- ClinicalTrials.gov ID
- NCT07457866
- Acronym / sponsor ID
- CaRE-4-alloBMT / 24-5483
- Conditions
- Allogenic Bone Marrow Transplantation
- Keywords
- allogenic bone marrow, rehabilitation, cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Jennifer JonesUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Aug 2028 (estimated)
- First posted
- 9 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CaRE-4-alloBMT intervention arm | Experimental | Behavioral: CaRE-4-alloBMTThe 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) |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CaRE-4-alloBMTThe 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) | Behavioural | CaRE-4-alloBMT intervention arm |
Primary outcome
36-Item Short Form Health Survey questionnaire (SF-36)
Time frame: 3 months post-discharge
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.
9 secondary outcomes
Initial hospital stay Transplant outcomes
Time frame: Year 4
Number of readmission Transplant outcomes
Time frame: Year 4
Number of days in hospital Transplant outcomes
Time frame: Year 4
Overall survival Transplant outcomes
Time frame: At year 4
EQ 5D 5L
Time frame: 9 months
Modified Patient-Generated Subjective Global Assessment
Time frame: 9 months
Hospital Anxiety and Depression Scale (HADS)
Time frame: 9 months
12-item World Health Organization's Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 9 months
Demographic and clinical information
Time frame: A one-time questionnaire to be completed at baseline/prior to initial assessment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jennifer M Jones, PhD principal investigator
UHN Princess Margaret Cancer Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CaRE-4-alloBMT in people with Allogenic Bone Marrow Transplantation, run by Jennifer Jones at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jennifer M Jones, PhD (14165818603, Jennifer.jones@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
36-Item Short Form Health Survey questionnaire (SF-36) (time frame: 3 months post-discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026; AzTrials last refreshed its copy on 2 Nov 2026.