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

Mass General Brigham

Status: Completed

Conditions: Hematopoietic Neoplasms; Hematopoietic Malignancy

Treatments: Behavioral: STEPP Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06010017

23-132

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

STEPP

Experimental group

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).

Treatment:

Behavioral: STEPP Intervention

Usual Care

No Intervention group

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.