Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP)

July 31, 2025 updated by: Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital

Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
136

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana-Farber Cancer Institute
      • Boston, Massachusetts, United States, 02215
        • Brigham and Women's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: STEPP

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
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.
No Intervention: Usual Care

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of STEPP
Time Frame: 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.
Up to 10 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Acceptability of STEPP
Time Frame: 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.
Up to Day +60 (+/- 10 days)
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time Frame: 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.
Up to Day +60 (+/- 10 days)
Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Time Frame: 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.
Up to Day +60 (+/- 10 days)
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
Time Frame: 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.
Up to Day +60 (+/- 10 days)
Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)
Time Frame: 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.
Up to Day +60 (+/- 10 days)
Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)
Time Frame: 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.
Up to Day +60 (+/- 10 days)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Efficacy based on the Cancer Self-Efficacy Scale-transplant (CASE-t)
Time Frame: Up to Day +60 (+/- 10 days)

Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.

The CASE-t assesses patients' confidence in managing the impact of their illness. Scores range from 0 to 170, with higher scores indicating greater self-efficacy.
Up to Day +60 (+/- 10 days)
Gratitude based on the Gratitude Questionnaire
Time Frame: Up to Day +60 (+/- 10 days)

Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.

The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.
Up to Day +60 (+/- 10 days)
Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
Time Frame: Up to Day +60 (+/- 10 days)

Compare positive affect using the 10-item Positive Affect Subscale from the Positive and Negative Affect Schedule (PANAS) between the two groups.

The Positive Affect Subscale ranges from 10 to 50, with higher scores indicating higher levels of positive affect.
Up to Day +60 (+/- 10 days)
Flourishing based on the Flourishing Scale
Time Frame: Up to Day +60 (+/- 10 days)

Compare flourishing using the 8-item Flourishing Scale between the two groups.

The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths.
Up to Day +60 (+/- 10 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Brigham and Women's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hermioni 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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 3, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 5, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-132

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

Contact the study investigator at hermioni_amonoo@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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