Hematopoietic NeoplasmsSTEPPNCT06010017
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
A study testing STEPP Intervention in people with Hematopoietic Neoplasms and Hematopoietic Malignancy, run by Brigham and Women's Hospital at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic Neoplasms, Hematopoietic Malignancy
- What is being tested?
- STEPP Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2024to 21 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 (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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02215
About this study
Official title: Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
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.
Read the detailed 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.
- Conditions
- Hematopoietic Neoplasms, Hematopoietic Malignancy
- Being tested
- STEPP Intervention
- Keywords
- Hematopoietic Neoplasms, Hematopoietic Malignancy, HSCT, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STEPP InterventionBehavioural
Peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team.
| Study group | Role | What they receive |
|---|---|---|
| STEPP | Experimental | 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). Receives: Behavioral: STEPP Intervention |
| Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of STEPP
The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.
Measured: Up to 10 weeks
Secondary outcomes (6)
Acceptability of STEPP
The 7-item Client Satisfaction Questionnaire (CSQ) will assess patient satisfaction with the STEPP intervention. Each question is scored from 0-4 to result in a total of 0-28. Higher scores indicate increased acceptability of the intervention.
Measured: Up to Day +60 (+/- 10 days)
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Compare anxiety symptoms using the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A) between the two groups. The HADS-A is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety.
Measured: Up to Day +60 (+/- 10 days)
Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Compare quality of life (QOL) using the 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) between the two groups.
The FACT-BMT consists of five subscales assessing well-being across the following domains: physical, functional, emotional, social, and bone marrow transplant symptoms. Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The FACT-BMT ranges from 0 to 148, with higher scores indicating better quality of life.
Measured: Up to Day +60 (+/- 10 days)
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
Compare depression symptoms using the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D) between the two groups. The HADS-D is comprised of 7 items that quantify the degree to which participants experience mood symptoms, with each item's score ranging from 0 to 3. Scores range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression.
Measured: Up to Day +60 (+/- 10 days)
Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)
Compare post-traumatic stress disorder symptoms using the 17-item Post-traumatic Stress Checklist-Civilian Version (PCL-C) between the two groups.
The PCL-C evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1 to 5 for a total score ranging from 17 to 85. A higher score indicates greater severity of post-traumatic stress disorder symptoms.
Measured: Up to Day +60 (+/- 10 days)
Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)
Compare social support using the 26-item Social Support Effectiveness Questionnaire (SSEQ) between the two groups.
The SSEQ is a validated instrument used in the oncological population to assess patients' perception of social support. The total score ranges from 0 to 80, with higher scores indicating more effective support.
Measured: Up to Day +60 (+/- 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start20 Feb 2024
- Primary completion3 Mar 2025
- Study completion21 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hematopoietic NeoplasmsStudies 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
- 136 participants (actual)
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 Amonoo, MD, MPP, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010017
- Sponsor's protocol ID
- 23-132
- Acronym
- STEPP
- Status last verified
- Jul 2025
- First submitted
- 21 Aug 2023
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Publications
Amonoo HL, Keane EP, Guo M, Gudenkauf LM, Boardman AC, Larizza IS, Wolfe ED, Mate-Kole MN, Healy BC, Cutler C, Jim HS, Lee SJ, Greer JA, Huffman JC, El-Jawahri A. A pilot randomized clinical trial of a peer support intervention for hematopoietic stem cell transplantation. Blood Adv. 2026 Jun 9;10(11):3987-3997. doi: 10.1182/bloodadvances.2025018918.
PubMed 41945755Keane EP, Guo M, Gudenkauf LM, Boardman AC, Song MT, Wolfe ED, Larizza IS, Mate-Kole MN, Healy BC, Huffman JC, El-Jawahri A, Amonoo HL. A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods. Contemp Clin Trials. 2025 Jan;148:107746. doi: 10.1016/j.cct.2024.107746. Epub 2024 Nov 19.
PubMed 39566722
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
- ClinicalTrials.gov ID
- NCT06010017
- Acronym / sponsor ID
- STEPP / 23-132
- Conditions
- Hematopoietic Neoplasms, Hematopoietic Malignancy
- Keywords
- Hematopoietic Neoplasms, Hematopoietic Malignancy, HSCT, Hematopoietic Stem Cell Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 21 Mar 2025 (actual)
- First posted
- 24 Aug 2023 (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 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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STEPP | Experimental | Behavioral: STEPP InterventionParticipants 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). |
| Usual Care | No intervention | –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. |
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 (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.
Key exclusion criteria (4 listed)
- 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.
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 InterventionPeer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team. | Behavioural | STEPP |
Primary outcome
Feasibility of STEPP
Time frame: Up to 10 weeks
The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.
6 secondary outcomes
Acceptability of STEPP
Time frame: Up to Day +60 (+/- 10 days)
Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
Time frame: Up to Day +60 (+/- 10 days)
Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
Time frame: Up to Day +60 (+/- 10 days)
Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
Time frame: Up to Day +60 (+/- 10 days)
Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)
Time frame: Up to Day +60 (+/- 10 days)
Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)
Time frame: Up to Day +60 (+/- 10 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 41945755Amonoo HL, Keane EP, Guo M, Gudenkauf LM, Boardman AC, Larizza IS, Wolfe ED, Mate-Kole MN, Healy BC, Cutler C, Jim HS, Lee SJ, Greer JA, Huffman JC, El-Jawahri A. A pilot randomized clinical trial of a peer support intervention for hematopoietic stem cell transplantation. Blood Adv. 2026 Jun 9;10(11):3987-3997. doi: 10.1182/bloodadvances.2025018918.
- Derived from this study: PubMed 39566722Keane EP, Guo M, Gudenkauf LM, Boardman AC, Song MT, Wolfe ED, Larizza IS, Mate-Kole MN, Healy BC, Huffman JC, El-Jawahri A, Amonoo HL. A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods. Contemp Clin Trials. 2025 Jan;148:107746. doi: 10.1016/j.cct.2024.107746. Epub 2024 Nov 19.
- Individual participant dataSharing planned: Yes. The Dana-Farber/Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor, Investigator, or designee. The protocol and statistical analysis plan will be made available on ClinicalTrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Related trials for Hematopoietic Neoplasms
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1
Autologous T Cells Transduced With Retroviral Vectors Expressing TCRs for Participant-specific Neoantigens in Patients With Hematologic Malignancies
Malignancy, Hematologic, Neoplasms, Hematologic
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
Active, not recruiting
A Collaborative Intervention for Improving Cancer Pain Management in Cancer Survivors
Hematopoietic and Lymphoid System Neoplasm, Malignant Solid Neoplasm
Active, not recruitingPhase 2
Group Retreat Psilocybin Therapy for the Treatment of Anxiety and Depression in Patients With Metastatic Solid Tumors or Incurable Hematologic Malignancies
Anxiety, Depression
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. This study is not recruiting at the moment.
Hermioni Amonoo, MD, MPP, MPH principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STEPP Intervention in people with Hematopoietic Neoplasms and Hematopoietic Malignancy, run by Brigham and Women's Hospital at 2 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 4 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: finished, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of STEPP (time frame: Up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06010017, which also lists 2 linked publications.
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 5 Aug 2025; AzTrials last refreshed its copy on 2 Nov 2026.