Abstract
BACKGROUND: Neurofibromatosis (NF) is a rare genetic condition associated with lower but modifiable quality of life (QoL). Although a virtual live video program (Relaxation Response Resiliency Program for Neurofibromatosis [3RP-NF]; efficacy randomized controlled trial underway) that we created has been made available, ongoing barriers impede some patients from engaging in this intervention. A necessary next step is to develop a stand-alone web-based intervention that reduces barriers to accessing NF-specific psychosocial care. OBJECTIVE: First, we aim to develop a web-based platform (Neurofibromatosis-Web [NF-Web]) of our mind-body resiliency program (3RP-NF) through qualitative interviews with participants from an adult efficacy randomized controlled trial. Second, we aim to iteratively optimize the feasibility, acceptability, credibility, and satisfaction of the NF-Web platform through open pilot trials with participant exit interviews and explore quantitative outcomes within this sample. Here, we describe the protocol and study design, intervention, and analysis plan. METHODS: For aim 1, we will invite completers from our efficacy trial to participate in qualitative interviews. We will use data from these interviews to adapt the content of the live video program for asynchronous delivery and understand how to create a user-friendly format for an engaging web platform. For aim 2, we will enroll eligible participants recruited for the efficacy trial who could not enroll because of treatment barriers. Eligible participants will complete QoL, depression, anxiety, pain, treatment satisfaction, and program credibility measures at baseline and posttest. Inclusion criteria are identical to those for the efficacy trial, including stress and coping difficulties (self-report), no change in antidepressant medication in the past 3 months, no psychotherapy in the past 3 months, no major upcoming surgeries in the next 12 months, English speaking, ability to complete questionnaires on the web and participate in live video interventions, and consent before participation. The primary outcomes are feasibility, treatment satisfaction, and credibility. The secondary outcomes include physical, psychological, social, and environmental QoL; depression; anxiety; pain intensity; and pain interference. We will enroll at least two group cohorts and iteratively refine the program based on participant feedback after each cohort completes the open pilot trial. RESULTS: This trial is ongoing. We have completed the interviews (n=23) and analyzed the data to construct the website. Afterward, we will recruit our cohorts for the trial (approximately n=15/cohort; total=30). Recruitment will end by May 2021, with plans to analyze the data by October 2021. CONCLUSIONS: We will develop the first web platform for people with NF with difficulties managing stress and NF symptoms and report on feasibility and preliminary effects in improving QoL and psychosocial functioning. NF-Web has potential to extend the reach of our 3RP-NF intervention by removing barriers to care, including lack of trained providers, scheduling difficulties, and appearance concerns. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/27526.