Clinical trial · Interventional
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematopoietic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Hematopoietic Neoplasms | Hematopoietic and Lymphoid Cell Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STEPP Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- STEPP
- description
- 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).
- interventionNames
- Behavioral: STEPP Intervention
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- 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.
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (2)
- DERIVEDAmonoo HL, Keane EP, Guo M, Gudenkauf LM, Boardman AC, Larizza IS, Wolfe ED, Mate-Kole MN, Healy BC, Cutler C, Jim HS, Lee SJ, Greer JA, Huffman JC, El-Jawahri A. A pilot randomized clinical trial of a peer support intervention for hematopoietic stem cell transplantation. Blood Adv. 2026 Jun 9;10(11):3987-3997. doi: 10.1182/bloodadvances.2025018918. PMID 41945755
- DERIVEDKeane 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