Status:
RECRUITING
Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Neurofibromatosis Type 1
Neurofibroma
Eligibility:
All Genders
5-120 years
Brief Summary
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 ...
Detailed Description
Background: * Individuals with neurofibromatosis type 1 (NF1) may develop plexiform neurofibroma (pNF) and cutaneous neurofibroma (cNF) tumors, both of which can impact one s physical appearance and ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Participants must self-report a diagnosis of NF1 OR be the caregiver of a child with NF1 (5-17 years old with plexiform neurofibroma \[pNF\] or 12-17 years old with cutaneous neurofibroma \[cNF\])
- The following for the participant or the caregiver of a child, as appropriate:
- Participants with NF1 must self-report a pNF and/or cNF tumor(s) that is visible to that individual OR others
- Caregivers of a child with NF1 must report a pNF and/or cNF tumor(s) that the child has that is visible to the child OR others
- Age requirements:
- \>= 8 years old (participants with pNF)
- \>= 12 years old (participants with cNF)
- \>= 12 years old (participants with pNF and cNF)
- \>= 18 years (caregivers)
- Access to device with internet
- Ability to understand English and comfort discussing their medical condition in English
- The ability of adult participant or caregiver of minor participants to understand and the willingness to sign a written informed consent document
- EXCLUSION CRITERIA:
- Physical or cognitive limitations that would prevent them from being able to participate in a focus group or interview, or unwillingness to do so
- Since we will aim to have no less than 25 percent of participants from underrepresented\* groups, individuals from represented groups may not be able to participate after we have reached the maximum target for represented groups. Consistent with best practices for scale development and validation, this will help ensure that the measures are appropriate for people from a variety of backgrounds.
- \* Underrepresented groups are defined as people who identify as African American or Black, American Indian, Alaska Native, Hispanic/Latine, Native Hawaiian, and other Pacific Islander.
- If saturation has been met within a particular age group, potential participants from that completed age group will no longer be eligible.
Exclusion
Key Trial Info
Start Date :
April 29 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT06880991
Start Date
April 29 2025
End Date
March 31 2027
Last Update
October 6 2025
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892