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Not yet recruitingNCT07577674STEPP-CareUpdated May 11, 2026

Peer Support Intervention for Caregivers of Patients Undergoing HSCT

An interventional study of STEPP-Care in Hematopoietic Stem Cell Transplantation, sponsored by Brigham and Women's Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Sponsored by Brigham and Women's Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The main purpose of this study is to determine if a tailored peer support intervention (STEPP-Care) is feasible among caregivers of patients undergoing hematopoietic stem cell transplantation (HSCT).

Read the detailed description

Caregivers play a vital role in recovery following hematopoietic stem cell transplantation (HSCT). However, caregiving can contribute to psychological distress and reduced quality of life (QOL). Additionally, HSCT caregivers report low self-efficacy and social support, protective factors which would otherwise help bolster their confidence in coping with the uncertainties and challenges of HSCT. Given the challenges and unmet psychosocial needs of HSCT caregivers, peer support interventions are poised to promote caregiver coping to address caregiver distress and quality of life concerns. With limited tailored peer support interventions, for HSCT caregivers, this study aims to assess the feasibility and acceptability of a peer support intervention (STEPP-Care) and examine its preliminary effects for improving QOL, caregiver burden, and psychological well-being compared to usual care in 90 caregivers of HSCT recipients.

02

Conditions studied

  • Hematopoietic Stem Cell Transplantation

Keywords

  • Caregivers
  • Stem Cell Transplantation
03

In context

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult caregivers (≥18 years of age) of patients with hematologic malignancies who are undergoing autologous or allogeneic HSCT at Dana-Farber Cancer Institute.
  • Is a relative or friend who is identified by the patient to be their caregiver.
  • Ability to speak, read, and respond in English
  • Has access to a phone.

Exclusion criteria

Exclusion Criteria:

  • Caregivers with acute or unstable psychiatric conditions or other cognitive conditions that the treating oncologist believes would prohibit informed consent or ability to adhere to study procedures.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    STEPP-Care

    STEPP-Care is a phone delivered six session structured peer support intervention.

    Behavioral: STEPP-Care

  • No intervention
    Usual Care

    Routine supportive care provided by social workers embedded in the HCT clinical teams will be used as the usual care control condition.

Interventions

  • BehavioralSTEPP-Care

    STEPP-Care is a phone-delivered six-session structured peer support intervention for caregivers of patients undergoing hematopoietic stem cell transplantation.

06

What researchers measure

Primary outcomes

  1. Intervention Feasibility

    Feasibility can be defined as \>/= 60% of STEPP-Care recipients completing 4/6 sessions

    Time frame: up to 10 weeks

  2. Intervention Acceptability

    Acceptability can be defined as average STEPP-Care intervention participant ratings \>20 on the Client Satisfaction Questionnaire

    Time frame: up to 10 weeks

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07577674
Lead sponsor
Brigham and Women's Hospital
Responsible party
Hermioni L.Amonoo, MD, MPP, MPH (Director, Well-Being and Cancer Research Program, Brigham and Women's Hospital) — Principal investigator
First posted
May 11, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Sep 30, 2028 (estimated)
Completion
Sep 30, 2031 (estimated)
Last update
May 11, 2026

Study contacts

Hermioni L. Amonoo, MD, MPP, MPH
Contact
hermioni_amonoo@dfci.harvard.edu
617-525-7472
Josephine Monahan, BA
Contact
jamonahan@bwh.harvard.edu
Hermioni L. Amonoo, MD, MPP, MPH
principal investigator · Brigham and Women's Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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