Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant

Study Overview
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Brief Summary
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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).

Detailed Description
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This is a randomized clinical trial to determine whether a 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). The CARE app was developed with the goal of addressing the needs of caregivers of HCT recipients. Participants will be randomized into one of two study groups: CARE app plus Usual Care versus Usual Care. Participation in this study is expected to last up to 100 days after HCT. It is expected that about 120 people will take part in this research study. The Leukemia and Lymphoma Society is supporting this research by providing funding.

Official Title
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Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)

Conditions
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Bone Marrow Transplant Complications, Hematologic Malignancy

Intervention / Treatment
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* Behavioral: CARE Application
* Behavioral: Usual Care


Participation Criteria
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Eligibility Criteria
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Caregiver Inclusion Criteria: Adult caregivers (>18 years) who is a relative or friend who live with the patient or is a designated caregiver as indicated during the transplant process. Caregiver of a patient receiving allogeneic or autologous HCT for the treatment of cancer Ability to comprehend and speak English as the CARE app is only available in English Patient 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARE App<br>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 | Behavioral: CARE Application<br>* Self-administered, psychosocial mobile application comprised of 5 learning modules.<br>|
| Active Comparator: Usual Care<br>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. | Behavioral: Usual Care<br>* Meeting with transplant social worker prior to HCT, consistent with standard-of-care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | Compare caregiver QOL as measured by the CARGOQOL between the two study groups. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | up to 60 days post-HCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | Compare caregiver QOL as measured by the CARGOQOL between the two study groups longitudinally. The CARGOQOL ranges from 0-100 with higher scores indicating better QOL | up to 100 days post HCT | 
| Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) | Compare caregiving burden as measured by the CRA between the two study groups. The CRA ranges from 24-120 with higher scores indicating greater caregiving burden | Up to 100 days post HCT | 
| Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety) | Compare anxiety symptoms as measured by the HADS-Anxiety between the study groups. The HADS-Anxiety ranges from 0-21 with higher scores indicating worse anxiety symptoms | Up to 100 days post HCT | 
| Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Compare depression symptoms as measured by the HADS-Depression between the study groups. The HADS-Depression ranges from 0-21 with higher scores indicating worse depression symptoms | Up to 100 days post HCT | 
| Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist | Compare post-traumatic stress symptoms as measured by the Post-Traumatic Stress Checklist-Civilian Version between the two groups. The checklist ranges from 17-85 with higher scores indicating worse PTSD Symptoms | Up to 100 days post HCT | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive Behavioral Therapy, CBT, Hematopoietic stem cell transplantation, HCT, Bone Marrow Transplant Complications, Hematologic Malignancy