Actively Recruiting

Age: 5Years - 120Years
All Genders
NCT06880991

Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study

Led by National Cancer Institute (NCI) · Updated on 2026-04-29

110

Participants Needed

1

Research Sites

152 weeks

Total Duration

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AI-Summary

What this Trial Is About

Background: Neurofibromatosis 1 (NF1) is a disease that causes tumors to grow along the nerves. These include plexiform neurofibromas (pNF) and cutaneous neurofibromas (cNF). Both pNF and cNF can be visible to other people. These tumors can affect a person s appearance and quality of life. Researchers want to be able to assess changes in appearance before and after treatment for NF1 tumors. Objective: To see if two questionnaires can help assess people s ratings about the appearance of their pNF and cNF tumors. Eligibility: People aged 8 years and older with pNF and people 12 years and older either with cNF or both pNF and cNF. Adult caregivers of children with pNF and cNF are also needed. Design: Participants will complete questionnaires on paper or by phone, computer, or tablet. They will answer questions about how they look, how they feel, and how they feel about the way they look. Participants will meet in at least 1 remote focus group or individual interview. The meeting will last about 1 hour. Each group will include 3 to 5 people, organized by age: 8 to 11 years, 12 to 17 years, 18 to 29 years, and over 30 years. Adult caregivers will meet in a group with other caregivers. They will discuss their NF1 symptoms; how their tumors look; how they feel about the way their tumors look; and their daily activities. They will give their opinions about 2 questionnaires about appearance. The group and individual meetings will be audio-recorded and transcribed. Information that can reveal individual identities will be removed.

CONDITIONS

Official Title

Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study

Who Can Participate

Age: 5Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Must self-report a diagnosis of NF1 or be a caregiver of a child with NF1 aged 5-17 years with pNF or 12-17 years with cNF
  • Participants with NF1 must have visible pNF and/or cNF tumors
  • Caregivers must report the child has visible pNF and/or cNF tumors
  • Participants with pNF must be at least 8 years old
  • Participants with cNF or both pNF and cNF must be at least 12 years old
  • Caregivers must be at least 18 years old
  • Access to a device with internet
  • Ability to understand and discuss medical condition in English
  • Willingness and ability to sign informed consent
Not Eligible

You will not qualify if you...

  • Physical or cognitive limitations preventing participation in focus groups or interviews
  • Unwillingness to participate in focus groups or interviews
  • Individuals from represented groups may be excluded after reaching target enrollment to ensure diversity
  • No longer eligible if the age group they belong to has reached saturation in enrollment

AI-Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

S

Staci M Peron, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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