A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT07774104 | Not Yet Recruiting

• 1 other identifier: 26-274
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 3

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.

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

Peer Support; Stem Cell Transplantation; Psychological Distress; Social Support

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (4)

• 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)

Study Arms (2)

Structured Peer Support Program (STEPP)

EXPERIMENTAL

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.

Behavioral: STEPP

Minimally Enhanced Usual Care

OTHER

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.

Other: Minimally Enhanced Usual Care Control

Interventions

STEPP BEHAVIORAL

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.

Structured Peer Support Program (STEPP)

Minimally Enhanced Usual Care Control OTHER

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.

Minimally Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Dana-Farber Cancer Institute: collaborator
• Fred Hutchinson Cancer Center: collaborator
• H. Lee Moffitt Cancer Center and Research Institute: collaborator

Study Sites (3)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

Location

Central Study Contacts

Hermioni Amonoo, MD, MPP, MPH

CONTACT

617-732-5056; hermioni_amonoo@dfci.harvard.edu

Erica Chen, BS

CONTACT

echen43@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Well-Being and Cancer Research Program

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): July 31, 2030
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)