Neurofibromatosis 1
Conditions
Brief summary
Neurofibromatosis Type 1 (NF1) often significantly impairs the mental health, social life, self-esteem, and quality of life of adolescent patients. These impacts can be made worse with the experience of NF1-related pain. Nearly three-quarters (73%) of caregivers report that pain interferes with their child's daily functioning, including their mental health, activity, sleep, relationships, and school attendance. Our team has developed the first mobile self-management platform app for adults with NF1-related pain, called iCanCope with NF. It is designed to help people to track their pain, sleep, mood, exercise, and energy level. It helps them set goals, gives suggestions about how to deal with NF1-related pain, and connects them with other individuals living with NF. The goal of this project is to test out a modified version of iCanCope with NF, for youth.
Interventions
OTHERiCanCope-NF Youth app
The iCanCope digital app offers symptom tracking, self-management skills training, goal setting, and disease education tailored for neurofibromatosis for youth.
OTHERiCanCope-NF Youth app + CM
The iCanCope digital app offers symptom tracking, self-management skills training, goal setting, and disease education tailored for neurofibromatosis for youth. In addition to the standardized orientation and push notifications, this app will also allow users to earn incentives aligned with their program engagement.
Sponsors
University Health Network, Toronto
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Blinded data analysis will be conducted by an independent biostatistician
Intervention model description
A three-arm, parallel group, pilot randomized controlled trial will be conducted.
Eligibility
Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosed with NF1 * Experience of NF1-related pain or discomfort that interfered with function over the past 2 weeks * Able to speak and read English
Exclusion criteria
* Moderate to severe cognitive impairments that would prevent independent use the iCanCope intervention, as determined through consultation with their health care provider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of iCanCope NF | 8 weeks | Success will be defined as meeting the following four combined criteria: 1) accrual rate \>70% 2) attrition rate \<20%; 3) technical difficulties in fewer than 10% of cases; and acceptability of mean 4 or higher on the acceptability e-scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Severity | 8 weeks | Pain severity will be measured using the 6-item validated Pain Scale from the PedsQL NF1 module. |
| Pain management | 8 weeks | Pain management is assessed will be measured using the 2-item validated Pain Management Scale from the PedsQL NF1 module |
| Depressive symptoms | 8 weeks | Depressive symptoms will be measured using the validated 8-item Patient-Reported Outcomes Measurement Information System (PROMIS®) Depression Short form for the assessment of depressive symptoms. |
| Pain Interference | 8 weeks | measured by the 16-item Pain Impact Scale from the PedsQL NF1 module. This measures reflect how much pain hinders activity and functioning. |
| Transition readiness | 8 weeks | Transition readiness which examines how prepared a pediatric patient is for adult care. This will be assessed using the 20-item validated Transition Readiness Assessment Questionnaire Version 5 (TRAQ 5.0) |
| Health-related quality of life | 8 weeks | Health-related quality of life will be measured using the 23-item PedsQL 4.0 Generic49 questionnaire. |
| Anxiety | 8 weeks | Anxiety will be assessed using the validated 10-item Worry Scale from the PedsQL NF1 Module. |
Contacts
Primary ContactLauren Harris, MSc(OT)
Outcome results
None listed