Hematopoietic Stem Cell Transplantation
Conditions
Keywords
Peer Support, Stem Cell Transplantation, Psychological Distress, Social Support
Brief summary
This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation.
Detailed description
Although peer support interventions benefit patients throughout the cancer care continuum, most existing interventions have been developed and tested in patients with solid tumors. Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) can especially benefit from structured peer support interventions to potentially address persistent gaps in psychosocial care. In the absence of evidence-based structured peer support interventions for HSCT recipients, the study investigators developed the STEPP intervention. STEPP pairs patients with HSCT survivors who are trained by clinical psychologists to deliver five manualized phone sessions prior to transplantation and through acute recovery. With this multi-site randomized clinical trial, the investigators aim to find out whether STEPP can improve psychological distress and quality of life, compared to a minimally enhanced usual care control condition, using validated assessment tools.
Interventions
BEHAVIORALSTEPP
STEPP, a phone-delivered structured peer support intervention for patients preparing to undergo hematopoietic stem cell transplantation (HSCT), consists of five sessions which integrates evidence-based strategies from cognitive-behavioral therapy, mindfulness, and positive psychology with informational, emotional, and practical support. STEPP is manualized and delivered by an HSCT survivor who is trained and supervised by a clinical psychologist.
OTHERMinimally Enhanced Usual Care Control
The minimally enhanced usual care control condition entail standard psychosocial care provided by social work and a comprehensive list of peer support resources available through participants academic hematopoietic stem cell transplantation centers and national organizations.
Sponsors
Brigham and Women's Hospital
Dana-Farber Cancer Institute
H. Lee Moffitt Cancer Center and Research Institute
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
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 (aged 18 years and older) with hematologic malignancies, scheduled to undergo autologous or allogeneic HSCT * Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
Exclusion criteria
* Patients undergoing HSCT for benign hematologic conditions * Patients with acute or unstable psychiatric or cognitive conditions (e.g., dementia) which the treating clinicians believe prohibits informed consent or compliance with study procedures * Patients undergoing HSCT for the second time
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale | 8 weeks (+/- 2 weeks) | Compare anxiety symptoms between the two groups at 8 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale | 8 weeks to 24 weeks (+/- 2 weeks) | Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale. The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms. |
| Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) | Up to 24 weeks (+/- 2 weeks) | Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT). The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT total score ranges from 0-148, with higher scores indicating better quality of life. |
| Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t) | Up to 24 weeks (+/- 2 weeks) | Compare self-efficacy longitudinally between the two groups using the 17-item Cancer Self-Efficacy Scale- transplant (CASE-t). The CASE-t score ranges from 0-170, with higher scores indicating higher levels of patient's confidence in managing the impacts of transplant. |
| Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS). | Up to 24 weeks (+/- 2 weeks) | Compare social support longitudinally between the two groups using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS). The MOS Social Support Survey score ranges from 0-100, with higher scores indicating higher levels of patient's perceived social support |
Countries
United States
Contacts
CONTACTHermioni Amonoo, MD, MPP, MPH
CONTACTErica Chen, BS
Outcome results
None listed