CARE App for Caregivers of Stem Cell Transplant Patients

Overseen By Areej El-Jawahri, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Benign hematologic conditions, Unstable psychiatric, others

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

Compensation: Varies

Number of Visits: 110

Duration: 60 days

120 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this research study is to determine whether a self-administered, psychosocial mobile application (CARE app) is effective at improving the quality of life and experience of caregivers of patients receiving hematopoietic stem cell transplantation (HCT).

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of the CARE App treatment for caregivers of stem cell transplant patients?

Research on similar mobile health apps for caregivers of stem cell transplant patients shows that these apps can help caregivers by providing patient-specific information and promoting resilience. Studies have found that using such apps can improve monitoring of patient symptoms and health, leading to better outcomes and high satisfaction among users. ^{1 2 3 4 5}

Is the CARE App safe for caregivers of stem cell transplant patients?

The available research does not provide specific safety data for the CARE App, but similar mobile health applications for caregivers and patients have been developed and tested without reported safety concerns. ^{1 3 6 7 8}

How is the CARE App treatment different from other treatments for caregivers of stem cell transplant patients?

The CARE App is unique because it is a mobile health application specifically designed to support caregivers of stem cell transplant patients by enhancing their resilience and managing their own health and well-being, unlike traditional treatments that focus solely on the patients themselves. ^{2 3 4 5 6}

Research Team

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adult caregivers of cancer patients undergoing stem cell transplants. Participants must understand and speak English, as the CARE app is English-only. They should be closely involved with the patient, either living together or designated as a caregiver during transplant.

Inclusion Criteria

I am caring for someone undergoing a stem cell transplant for cancer.

Ability to comprehend and speak English as the CARE app is only available in English

I am an adult caregiver for the patient, either living with them or officially designated.

Exclusion Criteria

Caregivers of patients undergoing HCT for benign hematologic conditions

Caregivers with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the CARE app and receive usual care, including meeting with a transplant social worker

60 days

Questionnaires at baseline, Day 10, Day 60

Follow-up

Participants are monitored for quality of life, caregiving burden, coping, anxiety, depression, PTSD symptoms, and self-efficacy

40 days

Questionnaire at Day 100

Treatment Details

Interventions

• CARE Application
• Usual Care

Trial Overview The study tests if a mobile application called CARE can help improve life quality for caregivers by providing psychosocial support. Caregivers will use this app alongside usual care methods to see if there's any benefit over standard practices alone.

Participant Groups

Group I: CARE App Experimental Treatment 1 Intervention

Participants randomized to the CARE app + usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100 post-HCT * use the CARE app from enrollment up to 60 days post-HCT: the CARE app includes 5 contains 5 modules and a 6th optional module * receive usual care as per HCT practice which entails meeting with a transplant social worker prior to HCT and as needed for extra visits

Group II: Usual Care Active Control 1 Intervention

Participants randomized to usual care will complete the following: * Questionnaires at baseline, Day 10, Day 60, and Day 100. * receive usual care as per HCT practice, which entails meeting with a transplant social worker prior to HCT and as needed for extra visits.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

The Leukemia and Lymphoma Society

Collaborator

Trials

87

Recruited

26,200+

Findings from Research

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]

The Roadmap mHealth app, designed for family caregivers of patients undergoing hematopoietic cell transplantation, was found to promote resilience effectively, as reported by users during qualitative interviews.

Participants highlighted that while the app was generally easy to use and helpful, improvements in personalization and reminders could enhance long-term engagement and support for caregivers during stressful care phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Resilience in Family Caregivers Using an mHealth App. Smeallie, E., Rosenthal, L., Johnson, A., et al.[2023]

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]

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]

A qualitative study involving 10 adult caregivers of patients who underwent hematopoietic stem cell transplantation (HSCT) was conducted to refine the survey for the Roadmap 2.0 mobile health app, highlighting the importance of user feedback in app development.

Cognitive interviews revealed areas for improvement in the survey design, such as clarifying transplant types and care contexts, which will enhance the app's effectiveness in supporting caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a National Caregiver Health Survey for Hematopoietic Stem Cell Transplant: Qualitative Study of Cognitive Interviews and Verbal Probing. Kedroske, J., Koblick, S., Chaar, D., 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 'Care Assistant' app was developed to support family caregivers of children with acute lymphoblastic leukaemia (ALL) by addressing key challenges such as limited access to medical information and difficulties in communication with healthcare providers.

The app includes eight modules designed to help caregivers track treatments, access financial and social assistance, and improve their knowledge about the disease, with plans for future studies to evaluate its usability and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing "Care Assistant": A smartphone application to support caregivers of children with acute lymphoblastic leukaemia. Wang, J., Yao, N., Wang, Y., et al.[2017]

References

1. 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]

2. Germany pubmed.ncbi.nlm.nih.gov

Enhancing Resilience in Family Caregivers Using an mHealth App. [2023]

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

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

4. 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]

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

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

6. Canada pubmed.ncbi.nlm.nih.gov

Development of a National Caregiver Health Survey for Hematopoietic Stem Cell Transplant: Qualitative Study of Cognitive Interviews and Verbal Probing. [2020]

7. 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]

8. England pubmed.ncbi.nlm.nih.gov

Developing "Care Assistant": A smartphone application to support caregivers of children with acute lymphoblastic leukaemia. [2017]