Hematopoietic Stem Cell TransplantationSTEPP-3NCT07774104
A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing STEPP in people with Hematopoietic Stem Cell Transplantation, run by Brigham and Women's Hospital at 3 sites in United States.
Trial summary
This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation. 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
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 31 Jul 2030
- 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 patients (aged 18 years and older) with hematologic malignancies, scheduled to undergo autologous or allogeneic HSCT
- Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
Who cannot join
- Patients undergoing HSCT for benign hematologic conditions
- Patients with acute or unstable psychiatric or cognitive conditions (e.g., dementia) which the treating clinicians believe prohibits informed consent or compliance with study procedures
- Patients undergoing HSCT for the second time
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erica Chen, BS contact
United States3 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Hermioni Amonoo, MD, MPP, MPH, Hermioni_Amonoo@dfci.harvard.edu
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Stephanie J Lee, MD, MPH, sjlee@fredhutch.org
Moffitt Cancer Center
Tampa, Florida, 33612
Heather Jim, PhD, heather.jim@moffitt.org
About this study
This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation.
Read the detailed description
Although peer support interventions benefit patients throughout the cancer care continuum, most existing interventions have been developed and tested in patients with solid tumors. Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) can especially benefit from structured peer support interventions to potentially address persistent gaps in psychosocial care. In the absence of evidence-based structured peer support interventions for HSCT recipients, the study investigators developed the STEPP intervention. STEPP pairs patients with HSCT survivors who are trained by clinical psychologists to deliver five manualized phone sessions prior to transplantation and through acute recovery. With this multi-site randomized clinical trial, the investigators aim to find out whether STEPP can improve psychological distress and quality of life, compared to a minimally enhanced usual care control condition, using validated assessment tools.
- Conditions
- Hematopoietic Stem Cell Transplantation
- Being tested
- STEPP, Minimally Enhanced Usual Care Control
- Keywords
- Peer Support, Stem Cell Transplantation, Psychological Distress, Social Support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPPBehavioural
STEPP, a phone-delivered structured peer support intervention for patients preparing to undergo hematopoietic stem cell transplantation (HSCT), consists of five sessions which integrates evidence-based strategies from cognitive-behavioral therapy, mindfulness, and positive psychology with informational, emotional, and practical support. STEPP is manualized and delivered by an HSCT survivor who is trained and supervised by a clinical psychologist.
Minimally Enhanced Usual Care ControlOther
The minimally enhanced usual care control condition entail standard psychosocial care provided by social work and a comprehensive list of peer support resources available through participants academic hematopoietic stem cell transplantation centers and national organizations.
| Study group | Role | What they receive |
|---|---|---|
| Structured Peer Support Program (STEPP) | Experimental | Participants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the intervention/experimental arm will receive the STEPP intervention, which pairs patients preparing for their transplant hospitalization with hematopoietic stem cell transplantation (HSCT) survivors for informational, emotional, and practical support.
Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. Receives: Behavioral: STEPP |
| Minimally Enhanced Usual Care | Other | Participants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the minimally enhanced usual care control arm will receive standard psychosocial care provided by social work plus a comprehensive list of local, regional, and national peer support resources.
Participants will complete questionnaires (in person, via computer or telephone, or by mail) at predetermined days per protocol. Receives: Other: Minimally Enhanced Usual Care Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Compare anxiety symptoms between the two groups at 8 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A).
The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms.
Measured: 8 weeks (+/- 2 weeks)
Secondary outcomes (4)
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Compare anxiety symptoms longitudinally between the two groups using the 7-item Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale.
The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms.
Measured: 8 weeks to 24 weeks (+/- 2 weeks)
Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Compare quality of life longitudinally between the two groups using the 47-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
The FACT-BMT consists of 5 subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. The FACT-BMT total score ranges from 0-148, with higher scores indicating better quality of life.
Measured: Up to 24 weeks (+/- 2 weeks)
Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t)
Compare self-efficacy longitudinally between the two groups using the 17-item Cancer Self-Efficacy Scale- transplant (CASE-t).
The CASE-t score ranges from 0-170, with higher scores indicating higher levels of patient's confidence in managing the impacts of transplant.
Measured: Up to 24 weeks (+/- 2 weeks)
Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS).
Compare social support longitudinally between the two groups using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS).
The MOS Social Support Survey score ranges from 0-100, with higher scores indicating higher levels of patient's perceived social support
Measured: Up to 24 weeks (+/- 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Jul 2030 (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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Fred Hutchinson Cancer Center, National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Hermioni L.Amonoo, MD, MPP, MPH, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07774104
- Sponsor's protocol ID
- 26-274
- Other IDs
- R01CA309099
- Acronym
- STEPP-3
- Status last verified
- Sep 2026
- First submitted
- 14 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- 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 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Structured Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07774104
- Acronym / sponsor ID
- STEPP-3 / 26-274
- Conditions
- Hematopoietic Stem Cell Transplantation
- Keywords
- Peer Support, Stem Cell Transplantation, Psychological Distress, Social Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, H. Lee Moffitt Cancer Center and Research Institute, Fred Hutchinson Cancer Center, National Cancer Institute (NCI)
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 19 Aug 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.
This randomized clinical trial is evaluating the impact of a structured peer support intervention (STEPP) on psychological distress and quality of life among patients undergoing hematopoietic stem cell transplantation.
Detailed description
Although peer support interventions benefit patients throughout the cancer care continuum, most existing interventions have been developed and tested in patients with solid tumors. Patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT) can especially benefit from structured peer support interventions to potentially address persistent gaps in psychosocial care. In the absence of evidence-based structured peer support interventions for HSCT recipients, the study investigators developed the STEPP intervention. STEPP pairs patients with HSCT survivors who are trained by clinical psychologists to deliver five manualized phone sessions prior to transplantation and through acute recovery. With this multi-site randomized clinical trial, the investigators aim to find out whether STEPP can improve psychological distress and quality of life, compared to a minimally enhanced usual care control condition, using validated assessment tools.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Structured Peer Support Program (STEPP) | Experimental | Behavioral: STEPPParticipants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the intervention/experimental arm will receive the STEPP intervention, which pairs patients preparing for their transplant hospitalization with hematopoietic stem cell transplantation (HSCT) survivors for informational, emotional, and practical support. Participants will complete questionnaires (in person, over the computer or telephone, or by mail) at predetermined days per protocol. |
| Minimally Enhanced Usual Care | Other | Other: Minimally Enhanced Usual Care ControlParticipants recruited from the Dana-Farber Cancer Institute, Moffitt Cancer Center, and Fred Hutchinson Cancer Center who are randomized to the minimally enhanced usual care control arm will receive standard psychosocial care provided by social work plus a comprehensive list of local, regional, and national peer support resources. Participants will complete questionnaires (in person, via computer or telephone, or by mail) at predetermined days per protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (aged 18 years and older) with hematologic malignancies, scheduled to undergo autologous or allogeneic HSCT
- Ability to speak, read, and respond to questions in English or Spanish to complete study procedures
Key exclusion criteria (3 listed)
- Patients undergoing HSCT for benign hematologic conditions
- Patients with acute or unstable psychiatric or cognitive conditions (e.g., dementia) which the treating clinicians believe prohibits informed consent or compliance with study procedures
- Patients undergoing HSCT for the second time
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 |
|---|---|---|
| STEPPSTEPP, a phone-delivered structured peer support intervention for patients preparing to undergo hematopoietic stem cell transplantation (HSCT), consists of five sessions which integrates evidence-based strategies from cognitive-behavioral therapy, mindfulness, and positive psychology with informational, emotional, and practical support. STEPP is manualized and delivered by an HSCT survivor who is trained and supervised by a clinical psychologist. | Behavioural | Structured Peer Support Program (STEPP) |
| Minimally Enhanced Usual Care ControlThe minimally enhanced usual care control condition entail standard psychosocial care provided by social work and a comprehensive list of peer support resources available through participants academic hematopoietic stem cell transplantation centers and national organizations. | Other | Minimally Enhanced Usual Care |
Primary outcome
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Time frame: 8 weeks (+/- 2 weeks)
Compare anxiety symptoms between the two groups at 8 weeks using the 7-item Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). The HADS-A subscale score ranges from 0-21, with higher scores indicating worse anxiety symptoms.
4 secondary outcomes
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale
Time frame: 8 weeks to 24 weeks (+/- 2 weeks)
Patient-Reported Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Time frame: Up to 24 weeks (+/- 2 weeks)
Patient-reported self-efficacy based on the Cancer Self-Efficacy Scale- transplant (CASE-t)
Time frame: Up to 24 weeks (+/- 2 weeks)
Patient-reported perceived social support based on the Medical Outcomes Study-Social Support Survey (MOS-SSS).
Time frame: Up to 24 weeks (+/- 2 weeks)
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 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Hematopoietic Stem Cell Transplantation
Not yet recruiting
Impact of Closed PBSC Collection With Reduced Gas-Phase Oxygen Exposure on Graft Quality and Early Engraftment in Allo-HSCT
Allogeneic Hematopoietic Stem Cell Transplantation (HSCT), Oxygen Deficiency
Not yet recruiting
MAC vs RIC for Transplantation in FLT3-ITD-Mutated AML Guided by UHS-NGS MRD ( FLT3 - MAC vs RIC )
ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION, Acute Myeloid Leukemia
RecruitingObservational study
Long-Term Follow up of Patients Undergoing Hematopoietic Stem Cell Transplantation, Cellular Therapy, or Gene Therapy
Cellular Immunotherapy, Adoptive, Genetic Therapy
Recruiting
Comprehensive Palliative Care After Stem Cell Transplantation: a Feasability Study
Hematopoietic Stem Cell Transplantation (HSCT)
RecruitingPhase 2
G-CSF Combined With IL-11 on Hematopoietic Reconstitution After Autologous Hematopoietic Stem Cell Transplantation
Mobilization of Hematopoietic Stem Cells (HSC) to Peripheral Blood (PB), Hematopoetic Stem Cell Transplantation
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.
Erica Chen, BS contact
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPP in people with Hematopoietic Stem Cell Transplantation, run by Brigham and Women's Hospital at 3 sites in United States.
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 2 inclusion and 3 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 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Amonoo, MD, MPP, MPH (617-732-5056, 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?
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (time frame: 8 weeks (+/- 2 weeks)). 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 10 Sep 2026; AzTrials last refreshed its copy on 30 Oct 2026.