Actively Recruiting
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
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Neurofibromatosis type 1 (NF1) is a condition where tumors called plexiform neurofibromas (pNF) and cutaneous neurofibromas (cNF) grow along nerves and can affect a person's appearance and quality of life. This research aims to evaluate two questionnaires designed to assess how people with NF1 and their caregivers perceive the visibility and appearance of these tumors. The study focuses on gathering feedback from both children and adults with NF1 as well as caregivers of affected children. Participants include individuals aged 8 years and older with pNF tumors and those 12 years and older with cNF or both tumor types, along with adult caregivers of children with these tumors. Participants will complete questionnaires either on paper or through phone, computer, or tablet. They will also join at least one remote focus group or individual interview lasting about one hour, grouped by age or caregiver status, to discuss their symptoms, tumor appearance, feelings about their appearance, and daily activities. The sessions will be recorded and transcribed with personal identifiers removed. During the study, researchers will collect qualitative feedback to evaluate and refine two new tumor visibility rating scales (TVRS-pNF and TVRS-cNF) and assess an existing measure of appearance concerns. The study will enroll up to 110 participants to ensure diverse representation. Participation involves completing questionnaires and attending remote group or individual discussions. The primary outcome is selecting the best questionnaire items to measure tumor visibility and appearance concerns based on participant input throughout the study.
CONDITIONS
Brief Title
Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must self-report a diagnosis of NF1 or be the caregiver of a child with NF1 aged 5 to 17 years with plexiform neurofibroma (pNF) or 12 to 17 years with cutaneous neurofibroma (cNF)
- Participants or their caregivers must report visible pNF and/or cNF tumors
- Participants with pNF must be 8 years or older
- Participants with cNF or both pNF and cNF must be 12 years or older
- Caregivers must be 18 years or older
- Access to a device with internet
- Ability to understand and discuss their medical condition in English
- Willingness and ability to sign informed consent
You will not qualify if you...
- Physical or cognitive limitations preventing participation in focus groups or interviews, or unwillingness to participate
- Individuals from represented groups may not participate after reaching enrollment targets to ensure diversity
- Potential participants from age groups where saturation of data has been reached may no longer be eligible
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Throughout the study
Participants complete questionnaires and take part in focus groups and/or interviews to provide feedback on tumor visibility and appearance concerns related to neurofibromatosis type 1.
1 or more remote sessions (online questionnaires, focus groups, or interviews)
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
S
Staci M Peron, Ph.D.
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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