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Trial Title:
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
NCT ID:
NCT06010017
Condition:
Hematopoietic Neoplasms
Hematopoietic Malignancy
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Conditions: Keywords:
Hematopoietic Neoplasms
Hematopoietic Malignancy
HSCT
Hematopoietic Stem Cell Transplantation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
STEPP Intervention
Description:
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.
Arm group label:
STEPP
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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hermioni Amonoo, MD, MPP, MPH
Phone:
617-525-7472
Email:
hermioni_amonoo@dfci.harvard.edu
Investigator:
Last name:
Hermioni Amonoo, MD, MPP, MPH
Email:
Principal Investigator
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Hermioni Amonoo, MD, MPP, MPH
Phone:
617-525-7472
Email:
hermioni_lokko@dfci.harvard.edu
Investigator:
Last name:
Hermioni Amonoo, MD, MPP, MPH
Email:
Principal Investigator
Start date:
February 20, 2024
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Brigham and Women's Hospital
Agency class:
Other
Source:
Brigham and Women's Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06010017
