A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP-3)

September 8, 2026 updated by: Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

350

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
    • Massachusetts
    • Washington
      • Seattle, Washington, United States, 98109

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Structured Peer Support Program (STEPP)

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
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.
Other: Minimally Enhanced Usual Care

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
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.
8 weeks (+/- 2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
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.
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)
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.
Up to 24 weeks (+/- 2 weeks)
Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t)
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.
Up to 24 weeks (+/- 2 weeks)
Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS).
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
Up to 24 weeks (+/- 2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

National Cancer Institute (NCI)
Dana-Farber Cancer Institute
Fred Hutchinson Cancer Center
H. Lee Moffitt Cancer Center and Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

July 31, 2030

Study Registration Dates

First Submitted

August 14, 2026

First Submitted That Met QC Criteria

August 14, 2026

First Posted (Actual)

August 19, 2026

Study Record Updates

Last Update Posted (Actual)

September 10, 2026

Last Update Submitted That Met QC Criteria

September 8, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 26-274
  • R01CA309099 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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