Clinical trial NCT06010017: Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
Official title: Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hematopoietic Neoplasms
Hematopoietic Malignancy
Keywords: Hematopoietic Neoplasms
Hematopoietic Malignancy
HSCT
Hematopoietic Stem Cell Transplantation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-08-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Feasibility of STEPP
timeFrame: Up to 10 weeks
Secondary outcomes:
measure: Acceptability of STEPP
timeFrame: Up to Day +60 (+/- 10 days)
measure: Anxiety Symptoms based on the Hospital Anxiety and Depression Scale-Anxiety Subscale (HADS-A)
timeFrame: Up to Day +60 (+/- 10 days)
measure: Quality of Life based on the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)
timeFrame: Up to Day +60 (+/- 10 days)
measure: Depression Symptoms based on the Hospital Anxiety and Depression Scale-Depression Subscale (HADS-D)
timeFrame: Up to Day +60 (+/- 10 days)
measure: Post-Traumatic Stress Symptoms based on the Post-traumatic Stress Checklist-Civilian Version (PCL-C)
timeFrame: Up to Day +60 (+/- 10 days)
measure: Social Support based on the Social Support Effectiveness Questionnaire (SSEQ)
timeFrame: Up to Day +60 (+/- 10 days)
Other outcomes:
measure: Self-Efficacy based on the Cancer Self-Efficacy Scale-transplant (CASE-t)
timeFrame: Up to Day +60 (+/- 10 days)
measure: Gratitude based on the Gratitude Questionnaire
timeFrame: Up to Day +60 (+/- 10 days)
measure: Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale
timeFrame: Up to Day +60 (+/- 10 days)
measure: Flourishing based on the Flourishing Scale
timeFrame: Up to Day +60 (+/- 10 days)
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Hermioni Amonoo, MD, MPP, MPH
role: PRINCIPAL_INVESTIGATOR
References: