Patient-Reported Outcome Questionnaire for Systemic Mastocytosis

Completed

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

• Registration Number: NCT02380222
• Lead Sponsor: Adelphi Values LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-02-26
• Study First Submitted QC: 2015-03-02
• Study First Posted: 2015-03-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-06
• Last Update Posted: 2017-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SM-AHNMD	Interview	-
MCL	Interview	-
ASM	Interview	-
SSM	Interview	-
ISM	Interview	-

Primary Outcome Measures

Name	Time	Method
Collection of qualitative interview data on the symptoms of advanced systemic mastocytosis	Once

Trial Locations

Locations (1)

Adelphi Values LLC; 🇺🇸 Boston, Massachusetts, United States