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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
Self-administered, psychosocial mobile application comprised of 5 learning modules.
Meeting with transplant social worker prior to HCT, consistent with standard-of-care.
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
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
Time frame: up to 60 days post-HCT
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 100 days post HCT
Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist
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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
Time frame: Up to 100 days post HCT