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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a mobile app called the CARE app, designed to assist caregivers of patients undergoing stem cell transplants. The app aims to enhance the quality of life and overall experience for these caregivers. Participants will either use the app alongside usual care or continue with the usual care, which includes regular meetings with a social worker. Ideal participants are adult caregivers who live with or are designated to care for patients receiving stem cell transplants for cancer and can understand and speak English. As an unphased trial, this study provides caregivers the opportunity to contribute to innovative research that could improve support for others in similar situations.

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 prior data suggests that the CARE app is safe for caregivers of stem cell transplant patients?

Research has shown that the CARE app is safe for caregivers. One study found that it improved their quality of life and reduced stress, depression, and PTSD symptoms. Participants have reported no negative effects from using the app, suggesting they handle it well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CARE App for caregivers of stem cell transplant patients because it offers a new way to support caregivers during a challenging time. Unlike standard care, which mainly involves meetings with a social worker, the CARE App provides interactive modules that caregivers can use at their convenience, potentially improving their ability to manage stress and support the patient. This app could enhance the quality of care by offering easily accessible resources and tools, making the caregiving process more manageable and less stressful.

What evidence suggests that the CARE app is effective for improving the quality of life for caregivers of stem cell transplant patients?

In this trial, participants will be randomized to receive either the CARE app alongside usual care or just usual care. Research has shown that the CARE app improves the lives of those caring for stem cell transplant patients. Studies have found that the app significantly reduces stress and emotional challenges caregivers face, such as feeling overwhelmed, depressed, or experiencing symptoms similar to PTSD (post-traumatic stress disorder). It also provides support to help caregivers manage more effectively. Overall, the CARE app is a promising tool for making caregiving easier and less stressful. ^{1 2 3 4 6}

Who Is on the Research Team?

Areej El-Jawahri, MD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO-25-00713

BMT-CARE App: A Randomized Controlled Trial of ... The BMT-CARE App led to significantly improved QOL, caregiving burden, depression, and PTSD symptoms among HSCT caregivers.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11979604/

a study protocol for the BMT-CARE app - PMC The study design is a non-blinded randomised controlled trial of a digital health intervention for caregivers of patients undergoing HSCT.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05709912

Mobile CARE-App to Promote Coping for Caregivers of ... This is a randomized clinical trial to determine whether a psychosocial mobile application (CARE app) is effective at improving the quality of life and ...

4. targetedonc.com targetedonc.com/view/digital-app-improves-caregiver-well-being-post-hsct

Digital App Improves Caregiver Well-Being Post HSCT The BMT-CARE App, as a psychosocial digital health intervention, effectively improves QOL and reduces psychological strain in HSCT caregivers.

5. curetoday.com curetoday.com/view/bmt-care-app-improves-quality-of-life-and-mental-health-for-caregivers

BMT-CARE App Improves Quality of Life and Mental Health ... BMT-CARE app boosted quality of life, lowered depression and PTSD symptoms, and improved coping mechanisms for caregivers of stem cell ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12356276/

A Mobile Health Intervention in Caregivers of Patients ... Caregivers are essential in supporting cancer patients, especially those undergoing hematopoietic cell transplantation (HCT).