NCT Number: NCT07774104
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Moffitt Cancer Center, Tampa, Florida, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Contact information is provided by the study sponsor or research team.
Erica Chen, BS
CONTACT
Hermioni Amonoo, MD, MPP, MPH
CONTACT
Brigham and Women's Hospital
Other
Acronym: STEPP-3
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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