Bone Marrow Transplant Complications, Graft-versus-Host Disease
Conditions
Keywords
neoplasms, hematologic diseases, neoplasms by site, hematologic neoplasms, graft-versus-host disease
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALHORIZONS Intervention
Therapist-delivered multidisciplinary group-based telehealth intervention comprised of 8 sessions
BEHAVIORALMinimally enhanced usual care
Receiving a standardized booklet with evidence-based information on chronic GHVD management and HST survivorship recommendations
Sponsors
Massachusetts General Hospital
University of Miami Sylvester Comprehensive Cancer Center
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
* Adult patients (≥ 18 years) who have undergone allogeneic HCT * Have moderate to severe cGVHD based on patient-report * Have ability to participate in English or Spanish language group telehealth intervention.
Exclusion criteria
* Patients with mild cGVHD based on their self-report. * Patients with a major untreated psychiatric or cognitive condition which the treating oncology clinicians believes interferes with the capacity to provide informed consent. * Patients with active relapsed disease requiring therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire | 10 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient quality of life (QOL) as measured by the Functional Assessment of Cancer Therapy-BMT (FACT-BMT) questionnaire | Up to 18 weeks post enrollment | 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 |
| Patient depression symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Up to 18 weeks post enrollment | 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 |
| Patient anxiety symptoms as measured by the Hospital Anxiety and Depression Scale (HADS-Depression) | Up to 18 weeks post enrollment | 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 depression symptoms. |
| Patient chronic graft-versus-host disease symptoms as measured with the Lee Symptom Scale | Up to 18 weeks post enrollment | 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 |
Countries
United States
Contacts
CONTACTLara Traeger PhD
CONTACTAreej El-Jawahri MD
PRINCIPAL_INVESTIGATORAreej El-Jawahri MD
Massachusetts General Hospital
Outcome results
None listed