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Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP)

Primary Purpose

Hematopoietic Neoplasms, Hematopoietic Malignancy

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
STEPP Intervention
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hematopoietic Neoplasms focused on measuring Hematopoietic Neoplasms, Hematopoietic Malignancy, HSCT, Hematopoietic Stem Cell Transplantation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dana-Farber Cancer Institute
  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

STEPP

Usual Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Acceptability of STEPP
The 8-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 0-24. Higher scores indicate increased acceptability of the intervention. Acceptability will also be assessed using weekly ratings of ease and utility of each intervention session (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and will use a threshold of a mean combined score of 7.0/10 for acceptability.
Anxiety Symptoms
The Hospital Anxiety Subscale (HADS), comprised of 7 items, will assess symptoms of anxiety in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety. The mean anxiety score will be reported for each cohort.
Quality of Life Longitudinally
The 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) will assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. The mean QOL score will be reported for each cohort.
Depression Symptoms
Assessed by the Hospital Depression Subscale (HADs) and Patient Health Questionnaire-9 (PHQ-9). The Hospital Depression Subscale (HADS), comprised of 7 items, will assess symptoms of depression in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The PHQ-9 is a 9-item measure that measures participant symptoms over the previous two weeks. Answers range from 0 to 3 with 0 representing "Not At All" to 3 representing "Nearly Every Day." A higher total score represents a greater severity of depression. The mean depression score will be reported for each cohort.
Post-Traumatic Stress Disorder (PTSD)
The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) to assess symptoms of post-traumatic stress in participants. The PCL is a 17 item self-reported measure that 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 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD.

Full Information

First Posted
August 21, 2023
Last Updated
September 3, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT06010017
Brief Title
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation
Acronym
STEPP
Official Title
Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
July 1, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 24 weeks. It is expected that about 80 people will participate in this randomized clinical trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic Neoplasms, Hematopoietic Malignancy
Keywords
Hematopoietic Neoplasms, Hematopoietic Malignancy, HSCT, Hematopoietic Stem Cell Transplantation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
STEPP
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
STEPP Intervention
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.
Primary Outcome Measure Information:
Title
Feasibility of STEPP
Description
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.
Time Frame
Up to 5 weeks
Secondary Outcome Measure Information:
Title
Acceptability of STEPP
Description
The 8-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 0-24. Higher scores indicate increased acceptability of the intervention. Acceptability will also be assessed using weekly ratings of ease and utility of each intervention session (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and will use a threshold of a mean combined score of 7.0/10 for acceptability.
Time Frame
Up to Day +60 (+/- 10 days)
Title
Anxiety Symptoms
Description
The Hospital Anxiety Subscale (HADS), comprised of 7 items, will assess symptoms of anxiety in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety. The mean anxiety score will be reported for each cohort.
Time Frame
Up to Day +100 (+/- 10 days)
Title
Quality of Life Longitudinally
Description
The 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) will assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. The mean QOL score will be reported for each cohort.
Time Frame
Up to Day +100 (+/- 10 days)
Title
Depression Symptoms
Description
Assessed by the Hospital Depression Subscale (HADs) and Patient Health Questionnaire-9 (PHQ-9). The Hospital Depression Subscale (HADS), comprised of 7 items, will assess symptoms of depression in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The PHQ-9 is a 9-item measure that measures participant symptoms over the previous two weeks. Answers range from 0 to 3 with 0 representing "Not At All" to 3 representing "Nearly Every Day." A higher total score represents a greater severity of depression. The mean depression score will be reported for each cohort.
Time Frame
Up to Day +100 (+/- 10 days)
Title
Post-Traumatic Stress Disorder (PTSD)
Description
The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) to assess symptoms of post-traumatic stress in participants. The PCL is a 17 item self-reported measure that 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 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD.
Time Frame
Up to Day +100 (+/- 10 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hermioni Amonoo, MD
Phone
617-732-4241
Email
hermioni_amonoo@dfci.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hermioni Amonoo, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hermioni Amonoo, MD
Phone
617-732-4241
Email
hermioni_lokko@dfci.harvard.edu
First Name & Middle Initial & Last Name & Degree
Hermioni Amonoo, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

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