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

90 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment care.coach Avatar™ for bone marrow transplant patients?

Research on similar digital health tools, like the TRU-BMT app, shows that using mobile health applications can help monitor symptoms and improve outcomes for bone marrow transplant patients by allowing earlier detection of issues and reducing hospital stays. ^{1 2 3 4 5}

Is the digital support for bone marrow transplant safe for humans?

The research articles do not provide specific safety data for the digital support treatment, but they suggest that mobile health apps have been used in similar contexts without reported safety issues. These apps are generally designed to help monitor symptoms and improve medication adherence, which implies they are considered safe for use in managing health conditions. ^{1 6 7 8 9}

How is the Digital Support for Bone Marrow Transplant treatment different from other treatments?

The Digital Support for Bone Marrow Transplant treatment using the care.coach Avatar™ is unique because it leverages digital technology to provide personalized support and symptom management for patients undergoing bone marrow transplants. Unlike traditional treatments, this approach uses an interactive avatar to engage with patients, potentially improving their care experience and outcomes by offering real-time assistance and monitoring. ^{1 9 10 11 12}

What is the purpose of this trial?

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 outpatient transplant. After care.coach Avatar™ content and scheduling ("digital intervention" or "program") has been optimized for outpatient allogeneic hematopoietic stem cell transplantation (HCT), a randomized controlled trial (RCT) will be conducted of the digital versus usual supportive care program for outpatient HCT recipients. Potential improvements in anxiety and quality of life will be evaluated, with the intent of increasing comfortability with outpatient transplant and expanding the population of eligible patients willing to receive their transplants in an outpatient setting.

Research Team

Victor Wang, MS

Principal Investigator

care.coach corporation

Chantal M Kerssens, PhD

Principal Investigator

care.coach corporation

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessing the Feasibility of a Novel mHealth App in Hematopoietic Stem Cell Transplant Patients. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Engaging Patients in Setting a Patient-Centered Outcomes Research Agenda in Hematopoietic Cell Transplantation. [2021]

3. England pubmed.ncbi.nlm.nih.gov

The SMILe integrated care model in allogeneic SteM cell TransplantatIon faciLitated by eHealth: a protocol for a hybrid effectiveness-implementation randomised controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

eHealth-Generated Patient Data in an Outpatient Setting after Hematopoietic Stem Cell Transplantation: A Scoping Review. [2022]

5. Germany 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Improving medication adherence monitoring and clinical outcomes through mHealth: A randomized controlled trial protocol in pediatric stem cell transplant. [2023]

7. Canada pubmed.ncbi.nlm.nih.gov

A Novel Health Information Technology Communication System to Increase Caregiver Activation in the Context of Hospital-Based Pediatric Hematopoietic Cell Transplantation: A Pilot Study. [2020]

8. Canada 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Evaluating health technology engagement among family caregivers of patients undergoing hematopoietic cell transplantation. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Development of an integrated model of care for allogeneic stem cell transplantation facilitated by eHealth-the SMILe study. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

A Protocol to Assess Feasibility, Acceptability, and Usability of Mobile Technology for Symptom Management in Pediatric Transplant Patients. [2020]

12. United States 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. [2023]