Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

Not Applicable

Active, not recruiting

• Conditions: Hematopoietic Malignancy; Hematopoietic Neoplasms
• Interventions: Behavioral: STEPP Intervention

• Registration Number: NCT06010017
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

The goal of this project is to refine a peer support intervention (STEPP) for patients undergoing hematopoietic stem cell transplantation (HSCT) and to conduct a randomized clinical trial to test its feasibility and preliminary efficacy for improving quality of life (QOL) and reducing psychological distress.

Participants will be randomized into one of two study groups: Peer Support Intervention (STEPP) vs. Usual Care. Randomization means a participant is placed into a group by chance. Participants will have an equal chance of being placed in either group.

Study procedures include screening for eligibility and questionnaires.

Participation in this study is expected to last about 10 weeks.

It is expected that about 80 people will participate in this randomized clinical trial.

Study Timeline

• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-21
• Study First Posted: 2023-08-24
• Study Start: 2024-02-20
• Status Verified: 2025-03
• Primary Completion: 2025-03-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
STEPP	STEPP 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 (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).

Primary Outcome Measures

Name	Time	Method
Feasibility of STEPP	Up to 10 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Acceptability of STEPP	Up to Day +60 (+/- 10 days)	The 7-item Client Satisfaction Questionnaire (CSQ) will assess patient satisfaction with the STEPP intervention. Each question is scored from 0-4 to result in a total of 0-28. Higher scores indicate increased acceptability of the intervention.
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)	Up to Day +60 (+/- 10 days)	Compare anxiety symptoms using the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) between the two groups. The HADS-A is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety.
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)	Up to Day +60 (+/- 10 days)	Compare depression symptoms using the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) between the two groups. The HADS-D is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression.
Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)	Up to Day +60 (+/- 10 days)	Compare quality of life (QOL) using the 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) between the two groups.; The FACT-BMT consists of five subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The FACT-BMT ranges from 0 to 148, with higher scores indicating better quality of life.
Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)	Up to Day +60 (+/- 10 days)	Compare post-traumatic stress disorder symptoms using the 17-item Post-traumatic Stress Checklist-Civilian Version (PCL-C) between the two groups.; The PCL-C evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1 to 5 for a total score ranging from 17 to 85. A higher score indicates greater severity of post-traumatic stress disorder symptoms.
Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)	Up to Day +60 (+/- 10 days)	Compare social support using the 26-item Social Support Effectiveness Questionnaire (SSEQ) between the two groups.; The SSEQ is a validated instrument used in the oncological population to assess patients' perception of social support. The total score ranges from 0 to 80, with higher scores indicating more effective support.

Trial Locations

Locations (2)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States