Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

Hematopoietic Malignancy Clinical Trial

— STEPP  

Official title:

Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06010017
• Other study ID #: 23-132
• Status: Recruiting
• Phase: N/A
• Start date: February 20, 2024
• Est. completion date: July 31, 2026

Study information

• Verified date: May 2024
• Source: Brigham and Women's Hospital
• Contact: Hermioni Amonoo, MD, MPP, MPH
• Phone: 617-525-7472
• Email: hermioni_amonoo[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 psychoeducation and supportive psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2026
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic Malignancy
• Neoplasms

Intervention

Behavioral:
• STEPP Intervention
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.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-Efficacy based on the Cancer Self-Efficacy Scale-transplant (CASE-t)	Compare self-efficacy using the Cancer Self-Efficacy Scale-transplant (CASE-t) between the two groups.; The CASE-t assesses patients' confidence in managing the impact of their illness. Scores range from 0 to 170, with higher scores indicating greater self-efficacy.	Up to Day +60 (+/- 10 days)
Other	Gratitude based on the Gratitude Questionnaire	Compare gratitude using the 6-item Gratitude Questionnaire between the two groups.; The Gratitude Questionnaire ranges from 6 to 42, with higher scores indicating a stronger propensity for experiencing gratitude in daily life.	Up to Day +60 (+/- 10 days)
Other	Positive Affect based on the Positive and Negative Affect Schedule Positive Affect Subscale	Compare positive affect using the 10-item Positive Affect Subscale from the Positive and Negative Affect Schedule (PANAS) between the two groups.; The Positive Affect Subscale ranges from 10 to 50, with higher scores indicating higher levels of positive affect.	Up to Day +60 (+/- 10 days)
Other	Flourishing based on the Flourishing Scale	Compare flourishing using the 8-item Flourishing Scale between the two groups.; The Flourishing Scale ranges from 8 to 56, with higher scores indicating having more psychological resources and strengths.	Up to Day +60 (+/- 10 days)
Primary	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.	Up to 10 weeks
Secondary	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.	Up to Day +60 (+/- 10 days)
Secondary	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.	Up to Day +60 (+/- 10 days)
Secondary	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.	Up to Day +60 (+/- 10 days)
Secondary	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.	Up to Day +60 (+/- 10 days)
Secondary	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.	Up to Day +60 (+/- 10 days)
Secondary	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.	Up to Day +60 (+/- 10 days)