JMIR Publications

ABSTRACT

Background:

The neurofibromatoses (NF) are rare genetic conditions associated with lower, but modifiable quality of life (QoL). Despite having a virtual live video program (Relaxation Response Resiliency Program for NF [3RP-NF]; randomized controlled efficacy trial [RCT] underway), ongoing barriers impede some patients from engaging in this intervention. Therefore, 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 (NF-Web) of our mind-body resiliency program (3RP-NF) through qualitative interviews with participants from the adult efficacy RCT. Second, we aim to iteratively optimize the 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/study design, intervention, and analysis plan.

Methods:

For Aim 1, we will invite completers from our efficacy trial to participate in qualitative interviews (N = 20). We will use data from these interviews to adapt the content of the live video program for asynchronous delivery and understand best format for the development of an engaging web platform. For Aim 2, we will enroll eligible participants recruited for the efficacy trial who could not enroll due to treatment barriers. Eligibile participants will complete QoL, depression, anxiety, pain, treatment satisfaction and program credibility measures at baseline and/or posttest. Inclusion criteria are identical to 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, able to complete questionnaires online and participate in live video interventions, and consented prior to participation. Primary outcomes are feasibility, treatment satisfaction, and credibility. Secondary outcomes include physical, psychological, social and environmental QoL, depression, anxiety, pain intensity and pain interference. We will enroll at least 2 group cohorts and iteratively refine the program based on participants feedback after each cohort.

Results:

The trial is currently ongoing. We are completing interviews (N = 23) and plan to analyze data to construct the website. Afterwards, we will recruit our cohorts of participants for the trial (N = ~15/cohort; T = 30). Recruitment will end May 2021 with plans to analyze 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 effect in improving QoL and psychosocial functioning. NF-web has the potential to dramatically extend the reach of our 3RP-NF intervention by removing important barriers to care including lack of trained providers, scheduling difficulties, and appearance concerns.