NCT07774104|Not Yet Recruiting
A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
STEPP-3
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STEPP-3
Sponsor study identifier
Secondary identifiers
NIH
interventional
350
1 country
3
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2026
Actual (reported)August 19, 2026
Actual (reported)December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
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.
8 weeks (+/- 2 weeks)
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
8 weeks to 24 weeks (+/- 2 weeks)
Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Up to 24 weeks (+/- 2 weeks)
Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t)
Up to 24 weeks (+/- 2 weeks)
Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS).
Up to 24 weeks (+/- 2 weeks)
Participants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the intervention/experimental arm will receive the STEPP intervention, which pairs patients preparing for their transplant hospitalization with hematopoietic stem cell transplantation (HSCT) survivors for informational, emotional, and practical support. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol.
Participants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the minimally enhanced usual care control arm will receive standard psychosocial care provided by social work plus a comprehensive list of local, regional, and national peer support resources. Participants will complete questionnaires (in person, via computer or telephone, or by mail) at predetermined days per protocol.
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.
Moffitt Cancer Center
Tampa, Florida, 33612, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
First Submitted
August 14, 2026
First Posted
August 19, 2026
Study Start
December 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
December 31, 2029
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 31, 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 10, 2026
Record last verified: 2026-09
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Source: ClinicalTrials.gov.
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