An interventional study of NF1 Educational Videos and Peer Navigator in Neurofibromatosis 1, sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-15.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
Among 11 studies in Neurofibromatosis 1 by Massachusetts General Hospital — 2 open to participants now, 2 under way, none of them phase 3. Neurofibromatosis 1 · Massachusetts General Hospital.
Among the 11 studies in Neurofibromatosis 1 by Massachusetts General Hospital, this one is the 4th largest by planned enrollment, is one of 2 that started in 2025, is one of 5 with no phase, and was the 11th registered.
176 studies on the registry are indexed under Neurofibromatosis 1; 43 are open to participants now.
This study's planned enrollment of 50 is above the median of 35 across 114 interventional studies indexed under Neurofibromatosis 1.
Browse Neurofibromatosis 1 studies →2 of the 11 studies in Neurofibromatosis 1 by Massachusetts General Hospital are open now, in 1 country. Each count lists the studies.
Of the 28 Neurofibromatosis 1 studies recruiting now, 18 (64%) set no upper age limit and 4 (14%) stop at 75 or younger; 19 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →11 studies; the count open now beside each. This study's row is marked.
First in 2008; this study’s year is marked. 2 started in 2025.
Median enrollment 20 across the 11 interventional studies. Of the 8 that completed or were terminated, 0 (0%) have results posted.
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
2 of the studies in Neurofibromatosis 1 by Massachusetts General Hospital that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06300502Massachusetts General HospitalAssessing the Efficacy of Repeat, Monthly Treatments of Deoxycholate for NF1 Associated Cutaneous Neurofibromas (cNFs) | 2027-02 |
| NCT07233408Massachusetts General HospitalTailoring an Online Platform to Promote Evidence-Based Care for Adults With Neurofibromatosis 1 and Low Health Literacy | 2027-05-30 |
Among the 11 studies in Neurofibromatosis 1 by Massachusetts General Hospital, from their registry updates:
Nothing recorded among them since 2026-09-25.
This decentralized, randomized study seeks to assess the feasibility, acceptability, and preliminary effectiveness of two approaches to assisting Neurofibromatosis 1 (NF1) patients with low health literacy improve their understanding of NF1 symptoms and care recommendations. Participants will be provided with personalized NF1 care letters for themselves and their doctors, along with either NF1 educational videos or a call with an NF1 peer navigator.
Adults with NF1 from across the U.S. who have upcoming annual wellness visits scheduled with a primary care provider (PCP) are eligible to enroll in the study. To see if you might be eligible, fill out a prescreening survey here: https://redcap.link/nfpeer
Background: Previous studies indicate that patient understanding of NF1 symptoms and screening for health issues such as hypertension, scoliosis, and cancers could be improved. Many individuals with NF1 have learning challenges, complicating their ability to access NF1 information. To address this gap, researchers are evaluating two interventions to promote understanding of NF1 care within adults with low health literacy.
Methods: Enrolled participants will complete baseline survey assessments online before their PCP visit and then be randomized to either the educational videos or peer navigator intervention group. Both groups will be given personalized letters, one for themselves and one for their clinician, that describe NF1 care recommendations. After attending their annual wellness visit, all participants will be asked to complete an online follow-up survey. A small subsample of participants will also be asked to do a virtual qualitative interview. No visits to Massachusetts General Hospital are required for this study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: NF1 Educational Videos · Other: Letters about NF1 Care
Other: Peer Navigator · Other: Letters about NF1 Care
Participants will receive access to NF1 educational videos that further explain NF1 health surveillance recommendations in advance of the patient's annual wellness visit.
Participants will receive a phone or video call from an NF1 peer navigator. The navigator will explain NF1 health surveillance recommendations and coach individuals on how to discuss these recommendations with their provider.
Participants will receive two letters about NF1 care, one for themselves and one for their primary care clinician, to read in advance of the patient's annual wellness visit.
Feasibility of Videos and NF1 Peer Navigator Use as an Addition to My NF Guide
* Recruitment (% of people that complete prescreening who are eligible) * Willingness to Enroll (% of prescreening-eligible people who enroll) * Retention (% of consented individuals who complete both the baseline survey and follow-up survey) * Intervention Completion (% of people who watch all videos or complete peer navigator meeting, as applicable based on intervention assigned)
Time frame: 2 weeks after PCP visit
Client Satisfaction Questionnaire (CSQ-8)
The CSQ-8 will be used to assess client satisfaction with the My NF Guide/PEER Resource package (i.e. personalized letters and either NF1 educational videos or peer navigator). It consists of 8 items rated on a 4-point Likert scale, yielding scores that range from 8 to 32. Higher scores indicate greater satisfaction with the services provided.
Time frame: 2 weeks after PCP visit
Telehealth Usability Questionnaire (TUQ)
The TUQ will be used to evaluate the ease of use, usefulness, and reliability with the My NF Guide/PEER Resource package (i.e. personalized letters and either NF1 educational videos or peer navigator). It consists of 21 items rated on a seven-point Likert scale ranging from "strongly disagree" to "strongly agree," with a higher average score indicating better usability. The overall usability score will be calculated as the mean of all applicable responses, and sub-scores for specific domains such as usefulness, ease of use, and reliability will be computed for detailed analysis.
Time frame: 2 weeks after PCP visit
Plan to share: No
Started Dec 2025 (actual). Primary completion is estimated for May 2027, 17 months after the start.
Of 21 interventional studies with no phase under Neurofibromatosis 1, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 52. This study's planned 17 months is below that.
How these figures are worked out, and which studies are left out of them.
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