NCT06880991 Development of Patient-Reported Outcome Measures Assessing Tumor Visibility and Appearance Concerns in Neurofibromatosis Type 1: A Qualitative Study
| NCT ID | NCT06880991 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Neurofibromatosis Type 1 |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-04-29 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2025-04-29 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
* 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 a 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.
Contact & Investigator
Staci M Peron, Ph.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06880991 clinical trial?
This trial is open to participants of all sexes, aged 5 Years or older, up to 120 Years, studying Neurofibromatosis Type 1. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06880991 currently recruiting?
Yes, NCT06880991 is actively recruiting participants. Contact the research team at martins@mail.nih.gov for enrollment information.
Where is the NCT06880991 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06880991 clinical trial?
NCT06880991 is sponsored by National Cancer Institute (NCI). The principal investigator is Staci M Peron, Ph.D. at National Cancer Institute (NCI). The trial plans to enroll 110 participants.