A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods outline

Emma P Keane; Michelle Guo; Lisa M Gudenkauf; Annabella C Boardman; M Tim Song; Emma D Wolfe; Isabella S Larizza; Manfred N Mate-Kole; Brian C Healy; Jeff C Huffman; Areej El-Jawahri; Hermioni L Amonoo

doi:10.1016/j.cct.2024.107746

A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods outline

Contemp Clin Trials. 2024 Nov 18:107746. doi: 10.1016/j.cct.2024.107746. Online ahead of print.

Authors

Affiliations

¹ Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA.
² Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA.
³ Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, FL, USA.
⁴ Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
⁵ Department of Health Services, University of Washington School of Public Health, Seattle, WA, USA.
⁶ Harvard T.H. Chan School of Public Health, Boston, MA, USA.
⁷ Harvard Medical School, Boston, MA, USA; Department of Neurology, Brigham and Women's Hospital, Boston, MA, USA.
⁸ Harvard Medical School, Boston, MA, USA; Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.
⁹ Harvard Medical School, Boston, MA, USA; Mass General Cancer Center, Massachusetts General Hospital, Boston, MA, USA.
¹⁰ Department of Psychiatry, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: hermioni_amonoo@dfci.harvard.edu.

PMID: 39566722
DOI: 10.1016/j.cct.2024.107746

Abstract

Background: Despite the association between peer support interventions and improved patient-reported outcomes (PROs) across cancer populations, there is a lack of structured peer support interventions for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT).

Objective: To test the feasibility, acceptability, and preliminary efficacy of a novel five-session, phone-delivered peer support intervention (STEPP: Supporting Transplant Experiences with Peer Program) for improving quality of life (QOL) and reducing psychological distress in patients undergoing HSCT.

Methods: This single-center pilot randomized clinical trial (RCT) will compare the STEPP intervention to usual transplant care among 90 patients hospitalized for HSCT. Eligible participants include adults (age ≥ 18 years) with hematologic malignancies hospitalized for autologous or allogeneic HSCT. The STEPP intervention provides informational, emotional, and practical support. To test the primary aim of intervention feasibility, we have established a priori benchmarks of 60 % enrollment of eligible patients and 60 % completion of at least 3 out of 5 intervention sessions among those randomized to STEPP. Acceptability will be assessed using the Client Satisfaction Questionnaire, with scores ≥3.0/4.0 indicating greater intervention acceptability. To test the secondary aim of preliminary efficacy, we will examine changes in PROs (e.g., anxiety symptoms and QOL) from pre- to post-intervention.

Discussion: This pilot RCT of a structured, phone-delivered peer support intervention tailored to the needs of patients preparing to undergo HSCT will elucidate the feasibility, acceptability, and preliminary efficacy of the STEPP intervention. We will then be poised to conduct a future, full-scale RCT to establish the efficacy of STEPP on patient outcomes.

Clinicaltrials: gov: NCT06010017.

Keywords: Hematopoietic stem cell transplantation; Peer mentor; Peer support; Quality of life; Social support; cancer.

Associated data

ClinicalTrials.gov/NCT06010017