Hematopoietic Stem Cell TransplantationSTEPP-CareNCT07577674
Peer Support Intervention for Caregivers of Patients Undergoing HSCT
A study testing STEPP-Care in people with Hematopoietic Stem Cell Transplantation, run by Brigham and Women's Hospital.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Stem Cell Transplantation
- What is being tested?
- STEPP-Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2026to 30 Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Josephine Monahan, BA contact
About this study
Official title: Peer Support Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation: Feasibility and Preliminary Efficacy Trial
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.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- STEPP-Care
- Keywords
- Caregivers, Stem Cell Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPP-CareBehavioural
STEPP-Care is a phone-delivered six-session structured peer support intervention for caregivers of patients undergoing hematopoietic stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| STEPP-Care | Experimental | STEPP-Care is a phone delivered six session structured peer support intervention. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Feasibility can be defined as >/= 60% of STEPP-Care recipients completing 4/6 sessions
Measured: up to 10 weeks
Intervention Acceptability
Acceptability can be defined as average STEPP-Care intervention participant ratings >20 on the Client Satisfaction Questionnaire
Measured: up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital
- Investigators
- Hermioni L. Amonoo, MD, MPP, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577674
- Sponsor's protocol ID
- 25-897
- Acronym
- STEPP-Care
- Status last verified
- May 2026
- First submitted
- 28 Apr 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support Intervention for Caregivers of Patients Undergoing Hematopoietic Stem Cell Transplantation: Feasibility and Preliminary Efficacy Trial
- ClinicalTrials.gov ID
- NCT07577674
- Acronym / sponsor ID
- STEPP-Care / 25-897
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Caregivers, Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2031 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPP-Care | Experimental | Behavioral: STEPP-CareSTEPP-Care is a phone delivered six session structured peer support intervention. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STEPP-CareSTEPP-Care is a phone-delivered six-session structured peer support intervention for caregivers of patients undergoing hematopoietic stem cell transplantation. | Behavioural | STEPP-Care |
Primary outcome
Intervention Feasibility
Time frame: up to 10 weeks
Feasibility can be defined as >/= 60% of STEPP-Care recipients completing 4/6 sessions
Intervention Acceptability
Time frame: up to 10 weeks
Acceptability can be defined as average STEPP-Care intervention participant ratings >20 on the Client Satisfaction Questionnaire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Josephine Monahan, BA contact
Hermioni L. Amonoo, MD, MPP, MPH principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing STEPP-Care in people with Hematopoietic Stem Cell Transplantation, run by Brigham and Women's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hermioni L. Amonoo, MD, MPP, MPH (617-525-7472, hermioni_amonoo@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: up to 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.