Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hematopoietic Neoplasms, Hematopoietic Malignancy

Intervention / Treatment
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* Behavioral: STEPP Intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: STEPP<br>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). | Behavioral: STEPP Intervention<br>* 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.<br>|
| No Intervention: Usual Care<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to Day +60 (+/- 10 days) | 
| 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. | Up to Day +100 (+/- 10 days) | 
| 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. | Up to Day +100 (+/- 10 days) | 
| 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. | Up to Day +100 (+/- 10 days) | 
| 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. | Up to Day +100 (+/- 10 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hematopoietic Neoplasms, Hematopoietic Malignancy, Hematopoietic Stem Cell Transplantation, HSCT