NCT07577674

Brief 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).

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
61mo left

Started Sep 2026

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

2 years

First QC Date

April 28, 2026

Last Update Submit

May 4, 2026

Conditions

Hematopoietic Stem Cell Transplantation

Keywords

CaregiversStem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • Intervention Feasibility

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

    up to 10 weeks

  • Intervention Acceptability

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

    up to 10 weeks

Study Arms (2)

STEPP-Care

EXPERIMENTAL

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

Behavioral: STEPP-Care

Usual Care

NO INTERVENTION

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

Interventions

STEPP-CareBEHAVIORAL

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

STEPP-Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hermioni L. Amonoo, MD, MPP, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hermioni L. Amonoo, MD, MPP, MPH

CONTACT

617-525-7472hermioni_amonoo@dfci.harvard.edu

Josephine Monahan, BA

CONTACT

jamonahan@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Well-Being and Cancer Research Program

Study Record Dates

First Submitted

April 28, 2026

First Posted

May 11, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2031

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share