Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-20

Study Completion Date

2025-03-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Hematopoietic Neoplasms Hematopoietic Malignancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

STEPP Intervention

Intervention Type 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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No