The goal of this study is to demonstrate the efficacy of a multidisciplinary group-based telehealth intervention (HORIZONS) compared to minimally enhanced usual care for improving self-management and quality of life for hematopoietic stem cell transplant (HSCT) survivors living with chronic graft-versus host disease, and to identify critical facilitators and barriers for HORIZONS implementation and adoption.
This is a randomized clinical trial to determine whether a multidisciplinary group-based telehealth intervention is effective at improving the quality of life and reducing psychosocial distress in patients living with chronic graft-versus-host disease. The HORIZONS intervention was developed with the goal of improving the experience and needs of patients living with chronic graft-versus-host disease. Participants will be randomized into one of the two study groups: HORIZONS plus usual care or minimally enhanced usual care. Participation in this study is expected to last up to 18 weeks after enrollment. The investigators expect that about 350 adult allogeneic hematopoietic cell transplant recipients with moderate to severe chronic graft versus host disease will take part in this research study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
350
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGPatient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire
Compare patient QOL as measured by the FACT-BMT between the two study groups. The FACT-BMT ranges from 0-164 with higher scores indicating better QOL
Time frame: At 10 weeks post-enrollment
Patient 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: At 10 weeks post enrollment
Patient 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: At 10 weeks post enrollment
Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale
Compare chronic graft versus host disease symptoms as measured by the Lee Symptom Scale. The Lee Symptom Scale ranges from 0 -100 with higher scores indicating worse symptomatology
Time frame: At 10 weeks post enrollment
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