Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

Study Overview
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Brief Summary
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The purpose of this study is to explore the key symptoms of individuals with systemic mastocytosis. Interviews of enrolled individuals will be conducted to learn about the disease symptoms and condition. The interview will last approximately 60 minutes and will be conducted by a trained interviewer, be audio-recorded (with patient consent), and all information provided by the patient will be treated confidentially and made anonymous so that it is non-identifiable. The interview may be conducted face-to-face, over the phone, or virtually via Skype, a free video conferencing program, depending upon the patient's geographic location. Patients will be compensated for their participating time. This is not a medication-related study, and no medication will be distributed or tested during this study. Participation in this study will not affect any treatment or assistance that a patient currently receives or may receive in the future.

Official Title
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Patient-Reported Outcome Questionnaire Development for Symptoms of Systemic Mastocytosis

Conditions
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Aggressive Systemic Mastocytosis (ASM), SM w Assoc Clonal Hema Non-mast Cell Lineage Disease (SM-AHNMD), Mast Cell Leukemia (MCL), Smoldering Systemic Mastocytosis (SSM), Indolent Systemic Mastocytosis (ISM) ISM Subgroup Fully Recruited

Intervention / Treatment
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* Other: Interview


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of one of the following conditions based upon World Health Organization (WHO) diagnostic criteria: aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated clonal hematologic non-mast cell lineage disease (SM-AHNMD), mast cell leukemia (MCL), smoldering systemic mastocytosis (SSM), indolent systemic mastocytosis (ISM) Diagnosis confirmed by bone marrow biopsy Fluency in English Willingness and ability to participate in a one-hour interview Exclusion Criteria: A condition or situation that would interfere with participation in an interview (e.g., cognitive impairment or disorder, alcohol or drug abuse) Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness Any other prior malignancy except for the following: Adequately treated basal cell or squamous cell skin cancer; In situ cervical cancer; Adequately treated Stage I or II cancer from which the subject is currently in complete remission, or other cancer from which the subject has been disease-free for 2 years

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASM<br> | Other: Interview<br>* Single interview lasting approximately one hour<br>|
| SM-AHNMD<br> | Other: Interview<br>* Single interview lasting approximately one hour<br>|
| MCL<br> | Other: Interview<br>* Single interview lasting approximately one hour<br>|
| SSM<br> | Other: Interview<br>* Single interview lasting approximately one hour<br>|
| ISM<br> | Other: Interview<br>* Single interview lasting approximately one hour<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis |  | Once | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic mastocytosis, Patient-reported outcome (PRO)