Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

NCT06010017 | Completed

• 1 other identifier: 23-132
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 2

Brief Summary

The main purpose of this study is to determine if a novel peer support intervention (STEPP) is feasible among patients undergoing hematopoietic stem cell transplantation (HSCT). The name of the intervention used in this research study is STEPP, a peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.

Conditions

Hematopoietic Neoplasms; Hematopoietic Malignancy

Keywords

Hematopoietic Neoplasms; Hematopoietic Malignancy; HSCT; Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Feasibility of STEPP

  The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.

  Up to 10 weeks

Secondary Outcomes (6)

• Acceptability of STEPP

  Up to Day +60 (+/- 10 days)

• Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)

  Up to Day +60 (+/- 10 days)

• Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)

  Up to Day +60 (+/- 10 days)

• Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)

  Up to Day +60 (+/- 10 days)

• Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)

  Up to Day +60 (+/- 10 days)

Other Outcomes (4)

• Self-Efficacy based on the Cancer Self-Efficacy Scale-transplant (CASE-t)

  Up to Day +60 (+/- 10 days)

• Gratitude based on the Gratitude Questionnaire

  Up to Day +60 (+/- 10 days)

• Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale

  Up to Day +60 (+/- 10 days)

Study Arms (2)

STEPP

EXPERIMENTAL

Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows: * Baseline self-reported assessment (in-person or remotely). * Virtual, STEPP intervention sessions 1x weekly for five weeks with peer mentor. * HSCT and hospitalization per standard of care. * Day +30 (+/- 10 days) and Day +60 (+/- 10 days) self-reported assessments. * Optional exit interview with study staff (40 participants).

Behavioral: STEPP Intervention

Usual Care

NO INTERVENTION

Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows: * Baseline self-reported assessment. * HSCT and hospitalization per standard of care. * Day +30 (+/- 10 days) and Day +60 (+/- 10 days) self-reported assessments.

Interventions

STEPP Intervention BEHAVIORAL

Peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team.

STEPP

Eligibility Criteria

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

You may qualify if:

• Adult patients (age \> 18 years) with a hematologic malignancy undergoing autologous or allogeneic HSCT.
• Ability to comprehend, read, and respond to questions in English as STEPP is only available in English.

You may not qualify if:

• Patients undergoing HSCT for benign hematologic conditions.
• Patients undergoing outpatient HSCT.
• Patients with acute or unstable psychiatric or cognitive conditions which the treating clinicians believes prohibits informed consent or compliance with study procedures.
• Patients undergoing HSCT for the second time.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• Keane EP, Guo M, Gudenkauf LM, Boardman AC, Song MT, Wolfe ED, Larizza IS, Mate-Kole MN, Healy BC, Huffman JC, El-Jawahri A, Amonoo HL. A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods. Contemp Clin Trials. 2025 Jan;148:107746. doi: 10.1016/j.cct.2024.107746. Epub 2024 Nov 19.

  PMID: 39566722 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Hermioni Amonoo, MD, MPP, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

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 21, 2023
• First Posted: August 24, 2023
• Study Start: February 20, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 21, 2025
• Last Updated: August 5, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the study investigator at hermioni\ amonoo@dfci.harvard.edu

Locations

US (2)