Digital Support for Bone Marrow Transplant

Overseen By Victor Wang, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: care.coach corporation

Disqualifiers: Severe impairments, Not fluent English

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 20

Duration: 30 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a digital program, care.coach Avatar™, can ease anxiety and improve the quality of life for people undergoing bone marrow transplants outside the hospital. Participants will either receive this digital support, which provides companionship, educational content, relaxation exercises, and more, or continue with the usual care involving educational materials and nurse meetings. The researchers aim to determine if the digital aid makes outpatient transplants more comfortable and appealing. Candidates may be a good fit if they are receiving a stem cell transplant outside the hospital and can communicate in English.

As an unphased trial, this study offers a unique opportunity to explore innovative digital support that could enhance the transplant experience.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the care.coach Avatar™ program is safe for patients undergoing outpatient transplant?

Research has shown that the care.coach Avatar™ is generally well-received by patients undergoing blood stem cell transplants. In studies, users reported feeling supported by the avatar, which helps manage symptoms and provides helpful information. No major negative effects have been linked to using the avatar in these situations. This digital tool aims to reduce anxiety and improve quality of life, suggesting it is a safe addition to regular supportive care. The goal is to enhance the patient's overall experience without adding any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The care.coach Avatar™ is unique because it combines traditional supportive care with a digital companion that offers more personalized and interactive support. Unlike the standard care, which usually involves educational binders and nurse meetings, this avatar provides companionship, educational modules, and mindfulness exercises directly to the patient. Researchers are excited about this approach because it could enhance patient engagement and self-management, potentially leading to better outcomes during the challenging bone marrow transplant process.

What evidence suggests that the care.coach Avatar™ is effective for improving anxiety and quality of life in outpatient transplant patients?

Research has shown that the care.coach Avatar™, which participants in this trial may receive, might help reduce anxiety and improve the quality of life for patients undergoing bone marrow transplants. Studies have found that patients using this avatar experienced better mental well-being. The avatar provides companionship, educational support, and mindfulness exercises to help manage stress. Early findings suggest these features can make the transplant process more comfortable. Although more research is needed, the initial results are promising for those considering outpatient transplants. ^{1 2 3 6 7}

Who Is on the Research Team?

Victor Wang, MS

Principal Investigator

care.coach corporation

Chantal M Kerssens, PhD

Principal Investigator

care.coach corporation

Are You a Good Fit for This Trial?

This trial is for patients undergoing outpatient bone marrow transplant (allogeneic hematopoietic stem cell transplantation) who are interested in a digital support program to potentially improve their anxiety and quality of life during the process.

Inclusion Criteria

I have an appointment for an outpatient stem cell transplant consultation.

Exclusion Criteria

Deemed by clinical staff or research assistant (RA) to be unable to converse with an avatar due to severe, uncorrectable hearing or vision impairment

I am not fluent in English.

Deemed by clinical staff or research assistant (RA) to be unable to converse with an avatar due to severe speech impairment that precludes understanding by staff (or by the avatar)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Transplant Preparation

Participants receive psychoeducational, exercise, and mindfulness interventions to prepare for HCT day 0

Up to D0

Treatment

Participants undergo outpatient hematopoietic stem cell transplantation and receive either usual supportive care or care.coach Avatar™ intervention

30 days

Daily check-ins

Follow-up

Participants are monitored for psychological and quality of life outcomes post-transplant

90 days

Assessments at Day 20 and Day 90 post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• care.coach Avatar™

Trial Overview The study is testing the care.coach Avatar™, a digital intervention designed to provide supportive care. It will be compared with usual supportive care programs to see if it can better help reduce anxiety and enhance quality of life for outpatient HCT recipients.

How Is the Trial Designed?

Group I: care.coach Avatar™ Experimental Treatment 1 Intervention

care.coach Avatar™ with usual supportive care. The avatar program includes companionship, HCT educational modules, relaxation and mindfulness exercises, simple (seated) physical exercises, nightly check ins, and symptom self-management as needed.

Group II: Usual Supportive Care Active Control 1 Intervention

Traditional supportive care comprising of a binder with HCT educational materials and regular meetings with a transplant nurse.

Who Is Running the Clinical Trial?

care.coach corporation

Lead Sponsor

Trials

1

Recruited

90+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Published Research Related to This Trial

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., et al.[2023]

A national survey of 948 unpaid family caregivers revealed that 65.4% used fitness apps and 41.3% used smartwatches, indicating a strong engagement with digital health technologies to support their well-being.

Caregivers of patients undergoing allogeneic transplants used more apps on average than those caring for patients with autologous transplants, suggesting that the type of transplant may influence the use of digital health tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating health technology engagement among family caregivers of patients undergoing hematopoietic cell transplantation. Raj, M., Gupta, V., Hoodin, F., et al.[2022]

The BMT Roadmap application was found to be useful for caregivers of HSCT patients, leading to increased caregiver activation and decreased feelings of burden during hospitalization.

Despite the positive effects on activation and burden, caregivers reported a decrease in overall quality of life at discharge, highlighting the need for ongoing support and resources for caregivers throughout the HSCT process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a health information technology tool addressing information needs of caregivers of adult and pediatric hematopoietic stem cell transplantation patients. Fauer, AJ., Hoodin, F., Lalonde, L., et al.[2020]

A 2-year initiative by the National Marrow Donor Program engaged patients, caregivers, and researchers to establish a patient-centered outcomes research (PCOR) agenda for hematopoietic cell transplantation (HCT), identifying six key areas of interest for future research.

The initiative highlighted the need for consistent measures and homogenous patient populations in HCT research to improve the comparability of outcomes, and it provided recommendations for priority research questions to address existing knowledge gaps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation. Burns, LJ., Abbetti, B., Arnold, SD., et al.[2021]

The TRU-BMT mHealth app was developed to help hematopoietic stem cell transplantation (HCT) patients monitor their health daily, aiming to improve symptom tracking and early detection of complications, with a pilot study involving 30 patients over 180 days.

Adherence to the app was around 30% daily and 44% weekly, and higher adherence correlated with better health outcomes, such as increased meal completion and shorter hospital stays, indicating the app's potential to enhance patient management during HCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. Racioppi, A., Dalton, T., Ramalingam, S., et al.[2023]

Medication non-adherence in children, especially those receiving hematopoietic stem cell transplants, is a significant issue, with rates between 50% and 80%, which can lead to life-threatening complications.

The BMT4me© mobile health app is designed to improve medication adherence by sending reminders and tracking medication-taking behaviors in real-time, and its efficacy will be evaluated in a randomized controlled trial comparing it to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. Ralph, JE., Sezgin, E., Stanek, CJ., et al.[2023]

The INTERACCT mobile app significantly improved the quality of self-reported medical data in adolescent HSCT patients compared to traditional paper diaries, with a score of 4.14 versus 3.77 (P=.02).

Adolescents, especially those with treatment-related complications, used the app longer and reported higher satisfaction, indicating that the app is a promising tool for enhancing patient compliance and communication in long-term cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Web-Based Mobile App (INTERACCT App) for Adolescents Undergoing Cancer and Hematopoietic Stem Cell Transplantation Aftercare to Improve the Quality of Medical Information for Clinicians: Observational Study. Lawitschka, A., Buehrer, S., Bauer, D., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11371478/

Human-in-the-loop avatar chatbot shows promise in ... This single-arm pilot study adapted a 'human-in-the-loop' (HITL) AI avatar chatbot for patients undergoing HCT, based on HCT team feedback, and ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/529495

RCT Supportive Care Outpatient RIC HCT The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06564233

NCT06564233 | RCT Supportive Care Outpatient RIC HCT A Randomized Controlled Trial of an Avatar-based Supportive Care Intervention for Patients Undergoing Outpatient Stem Cell Transplantation.

4. dana-farber.org dana-farber.org/clinical-trials/24-183

A Randomized Controlled Trial of an Avatar-based ... The overall goal of this study is to assess the efficacy of the care.coach Avatar™ in improving anxiety and quality of life for patients undergoing ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38902537/

Human-in-the-loop avatar chatbot shows promise in ... - PubMed Human-in-the-loop avatar chatbot shows promise in supporting hematopoietic stem cell transplantation patients. Bone Marrow Transplant. 2024 Sep;59(9):1323 ...

6. researchgate.net researchgate.net/publication/381602667_Human-in-the-loop_avatar_chatbot_shows_promise_in_supporting_hematopoietic_stem_cell_transplantation_patients

Human-in-the-loop avatar chatbot shows promise ... Human-in-the-loop avatar chatbot shows promise in supporting hematopoietic stem cell transplantation patients ... To read the full-text of this ...

7. colab.ws colab.ws/articles/10.1038%2Fs41409-024-02334-y

Human-in-the-loop avatar chatbot shows promise in ... - CoLab Human-in-the-loop avatar chatbot shows promise in supporting hematopoietic stem cell transplantation patients ; American Society of Clinical ...