CaRE-4-alloBMT for Bone Marrow Transplant
(CaRE-4-alloBMT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate how well the CaRE-4-alloBMT program supports patients undergoing bone marrow transplants for blood cancers. It compares an enhanced care plan, which includes exercise, nutrition, and emotional support, to the standard care patients typically receive. The trial seeks to determine if the new program can improve recovery and overall health. Individuals scheduled for a bone marrow transplant and receiving treatment for blood cancer might be suitable candidates, particularly if they can access online materials and speak English. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance patient care and recovery strategies.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the CaRE-4-alloBMT program is safe for participants. In a previous study, the program was well-tolerated alongside standard cancer treatments, with no major reports of harmful side effects. The main goal was to integrate the program into regular care seamlessly. Participants managed the physical activities and self-care tasks effectively.
The program includes exercise plans, remote monitoring with devices like Fitbits, and support from health professionals. These components aim to improve overall health without causing harm. While no treatment is completely risk-free, evidence so far suggests that this approach is safe for individuals undergoing bone marrow transplants.12345Why are researchers excited about this trial?
Researchers are excited about the CaRE-4-alloBMT program because it introduces a comprehensive, tech-savvy approach to cancer rehabilitation that goes beyond standard care. Unlike traditional treatments that mainly involve self-directed resources and basic physiotherapy, CaRE-4-alloBMT leverages eHealth technologies like Fitbit devices for remote monitoring of heart rate, sleep, and weight. Additionally, it incorporates behavior change theories and offers personalized exercise plans and self-management skills education, all supported by regular remote check-ins with a kinesiologist. This integrated approach aims to address barriers to accessing rehabilitation and enhance the overall recovery process for patients undergoing bone marrow transplants.
What evidence suggests that the CaRE-4-alloBMT intervention could be effective for bone marrow transplant patients?
This trial will compare the CaRE-4-alloBMT program with usual care for patients undergoing bone marrow transplants. Research has shown that the CaRE-4-alloBMT program can enhance recovery after these transplants. Specifically, patients in a similar program previously demonstrated improved physical activity and better health management. The program includes exercise, healthy eating, and mental health support, which can alleviate side effects and enhance overall well-being. Early signs suggest that using devices like Fitbit to track health can also improve outcomes. Overall, the program is considered safe and may aid recovery after a transplant.12367
Who Is on the Research Team?
Jennifer M Jones, PhD
Principal Investigator
UHN Princess Margaret Cancer Centre
Are You a Good Fit for This Trial?
This trial is for adults over 18 with blood cancers who are getting a bone marrow transplant at Princess Margaret, can use online materials, and understand English. People having their first or second transplant can join if they meet these criteria.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-transplant Preparation
Participants complete a questionnaire package and an initial assessment with a registered Kinesiologist, and are randomized into either the CaRE-4-alloBMT or Usual Care group.
Treatment
Participants receive the CaRE-4-alloBMT intervention or Usual Care from pre-transplant through to 6 months post-transplant.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at hospital admission, discharge, 3 months post-discharge, and 6 months post-discharge.
What Are the Treatments Tested in This Trial?
Interventions
- CaRE-4-alloBMT
Trial Overview
The study compares usual care after a bone marrow transplant to usual care plus the CaRE-4-alloBMT rehab program, which focuses on exercise, nutrition, and self-management from before the transplant up to six months after.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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)
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Jones
Lead Sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Citations
Protocol for a phase II feasibility pilot randomized ...
We developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4- ...
2.
ashpublications.org
ashpublications.org/bloodadvances/article/8/18/4778/516927/A-phase-2-study-of-a-longitudinal-multidimensionalA phase 2 study of a longitudinal multidimensional ...
A phase 2 randomized controlled trial (RCT) was conducted to assess the feasibility, acceptability, and impact of CaRE-4-alloBMT, a longitudinal ...
Cancer Rehab Program for Allogenic Bone and Marrow ...
Objectives: i) To test the feasibility and safety of CaRE-4-alloBMT plus standard best practice cancer care compared to standard best practice cancer care alone ...
Protocol for a phase II feasibility pilot randomized controlled trial
We developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4- ...
Protocol for a phase II feasibility pilot randomized controlled trial
A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT)
CaRE-4-alloBMT for Bone Marrow Transplant
The CaRE-4-alloBMT medical study, being run by Jennifer Jones, is evaluating whether CaRE-4-alloBMT will have tolerable side effects ...
Study Details | NCT01850108 | Non-Myeloablative ...
Even when it is clear that alloBMT can give to these patients an improvement in their disease, myeloablative transplants have important toxicities and ...
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