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Peer Support Intervention for Blood Cancer (STEPP Trial)
N/A
Waitlist Available
Led By Hermioni Amonoo, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day +100 (+/- 10 days)
Awards & highlights
STEPP Trial Summary
This trial will test if a novel peer support intervention (STEPP) can help patients undergoing HSCT. It includes 5 learning modules on psychotherapy and psychoeducation tailored to the patients' needs.
Who is the study for?
This trial is for English-speaking adults over 18 with blood cancers who are undergoing hematopoietic stem cell transplantation (HSCT). It's not suitable for those having outpatient HSCT, or individuals with acute psychiatric or cognitive conditions that prevent informed consent or study compliance.Check my eligibility
What is being tested?
The trial is testing STEPP, a peer support intervention with five modules designed to educate and provide psychotherapy support tailored to the needs of patients receiving HSCT. The goal is to see if this approach is practical and helpful.See study design
What are the potential side effects?
Since STEPP involves educational and supportive therapy sessions rather than medication, typical drug side effects aren't expected. However, participants may experience emotional distress or discomfort discussing their condition.
STEPP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day +60 (+/- 10 days)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day +60 (+/- 10 days)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of STEPP
Secondary outcome measures
Acceptability of STEPP
Anxiety Symptoms
Depression Symptoms
+2 moreSTEPP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: STEPPExperimental Treatment1 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 (in-person or remotely).
Virtual, STEPP intervention sessions 1x weekly for five weeks with peer mentor.
HSCT and hospitalization per standard of care.
Day +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.
Optional exit interview with study staff (10-20 participants).
Group II: Usual CareActive Control1 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 +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,868 Total Patients Enrolled
2 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
Brigham and Women's HospitalLead Sponsor
1,609 Previous Clinical Trials
11,470,247 Total Patients Enrolled
2 Trials studying Blood Cancers
90 Patients Enrolled for Blood Cancers
Hermioni Amonoo, MDPrincipal InvestigatorDana-Farber Cancer Institute
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants needed for this experiment?
"The clinicaltrials.gov page for this medical trial indicates that recruitment has been closed since September 3rd 2023, when it was last updated following its initial posting on February 1st 2024. Fortunately, there are still 2708 other studies actively recruiting patients right now."
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