Clinical trial NCT05709912: Mobile CARE-App to Promote Coping for Caregivers of Patients Receiving Stem Cell Transplant
Official title: Randomized Controlled Trial of a Psychosocial Mobile Application (App) to Promote Coping for Caregivers of Patients Receiving Hematopoietic Cell Transplantation (HCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Marrow Transplant Complications
Hematologic Malignancy
Keywords: Cognitive Behavioral Therapy
CBT
Hematopoietic stem cell transplantation
HCT
Bone Marrow Transplant Complications
Hematologic Malignancy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: The Leukemia and Lymphoma Society
First posted: 2023-02-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
timeFrame: up to 60 days post-HCT
Secondary outcomes:
measure: Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire
timeFrame: up to 100 days post HCT
measure: Caregiving burden as measured by the Caregiver Reaction Assessment (CRA)
timeFrame: Up to 100 days post HCT
measure: Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety)
timeFrame: Up to 100 days post HCT
measure: Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression)
timeFrame: Up to 100 days post HCT
measure: Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist
timeFrame: Up to 100 days post HCT
Other outcomes:
measure: Coping as measured by the Measure of Current Status (MOCS)
timeFrame: Up to 100 days post-HCT
measure: Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale
timeFrame: Up to 100 days post-HCT
measure: Usability of the CARE app using the System Usability Scale
timeFrame: up to 60 days post-HCT
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Areej El-Jawahri, MD
role: PRINCIPAL_INVESTIGATOR
References: