Bone Marrow Transplant Complications, Hematologic Malignancy
Conditions
Keywords
Cognitive Behavioral Therapy, CBT, Hematopoietic stem cell transplantation, HCT, Bone Marrow Transplant Complications, Hematologic Malignancy
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.
Interventions
BEHAVIORALCARE Application
Self-administered, psychosocial mobile application comprised of 5 learning modules.
BEHAVIORALUsual Care
Meeting with transplant social worker prior to HCT, consistent with standard-of-care.
Sponsors
The Leukemia and Lymphoma Society
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | up to 60 days post-HCT | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Caregiving burden as measured by the Caregiver Reaction Assessment (CRA) | Up to 100 days post HCT | 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 |
| Anxiety symptoms as measured by the Hospital Anxiety and Depression scale (HADS-Anxiety) | Up to 100 days post HCT | 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 |
| Depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Up to 100 days post HCT | 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 |
| Post-traumatic stress symptoms (PTSD) as measured by the PTSD Checklist | Up to 100 days post HCT | 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 |
| Caregiver quality of life (QOL) as measured by the Caregiver Oncology Quality of Life (CARGOQOL) questionnaire | up to 100 days post HCT | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usability of the CARE app using the System Usability Scale | up to 60 days post-HCT | Assess the usability of the care app (in those receiving the intervention) using the System Usability Scale, which ranges 0-100 with higher scores indicating better usability |
| Self-efficacy as measured by the Cancer self-efficacy-transplant (CASE-t) scale | Up to 100 days post-HCT | Compare caregiver self-efficacy as measured by the CASE-t between the two study groups. The scale ranges from 0-170 with higher scores indicating better self-efficacy |
| Coping as measured by the Measure of Current Status (MOCS) | Up to 100 days post-HCT | Comparing caregiver coping as measured by the MOCS between the two study groups. The scale ranges from 0-52 with higher scores indicating higher coping skills |
Countries
United States
Outcome results
None listed