Peer Support Intervention for Caregivers of Patients Undergoing HSCT (STEPP-Care)

May 4, 2026 updated by: Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

Peer Support Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation: Feasibility and Preliminary Efficacy Trial

The main purpose of this study is to determine if a tailored peer support intervention (STEPP-Care) is feasible among caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Caregivers play a vital role in recovery following hematopoietic stem cell transplantation (HSCT). However, caregiving can contribute to psychological distress and reduced quality of life (QOL). Additionally, HSCT caregivers report low self-efficacy and social support, protective factors which would otherwise help bolster their confidence in coping with the uncertainties and challenges of HSCT. Given the challenges and unmet psychosocial needs of HSCT caregivers, peer support interventions are poised to promote caregiver coping to address caregiver distress and quality of life concerns. With limited tailored peer support interventions, for HSCT caregivers, this study aims to assess the feasibility and acceptability of a peer support intervention (STEPP-Care) and examine its preliminary effects for improving QOL, caregiver burden, and psychological well-being compared to usual care in 90 caregivers of HSCT recipients.

Study Type

Interventional

Enrollment (Estimated)

90

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

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 caregivers (≥18 years of age) of patients with hematologic malignancies who are undergoing autologous or allogeneic HSCT at Dana-Farber Cancer Institute.
  • Is a relative or friend who is identified by the patient to be their caregiver.
  • Ability to speak, read, and respond in English
  • Has access to a phone.

Exclusion Criteria:

  • Caregivers with acute or unstable psychiatric conditions or other cognitive conditions that the treating oncologist believes would prohibit informed consent or ability to adhere to study procedures.

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: STEPP-Care
STEPP-Care is a phone delivered six session structured peer support intervention.
Behavioral: STEPP-Care
STEPP-Care is a phone-delivered six-session structured peer support intervention for caregivers of patients undergoing hematopoietic stem cell transplantation.
No Intervention: Usual Care
Routine supportive care provided by social workers embedded in the HCT clinical teams will be used as the usual care control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention Feasibility
Time Frame: up to 10 weeks
Feasibility can be defined as >/= 60% of STEPP-Care recipients completing 4/6 sessions
up to 10 weeks
Intervention Acceptability
Time Frame: up to 10 weeks
Acceptability can be defined as average STEPP-Care intervention participant ratings >20 on the Client Satisfaction Questionnaire
up to 10 weeks

Collaborators and Investigators

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

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Hermioni L. Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

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)

September 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2031

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 11, 2026

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 25-897

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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