iCanCope With NF: Innovating an Efficacious Digital Self-management and Transitional Care Program for Adolescents With Neurofibromatosis

Not Applicable

Not yet recruiting

• Conditions: Neurofibromatosis 1

• Registration Number: NCT07077408
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-03
• Study First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Study Start: 2026-03-01
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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)
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.
Anxiety	8 weeks	Anxiety will be assessed using the validated 10-item Worry Scale from the PedsQL NF1 Module.
Health-related quality of life	8 weeks	Health-related quality of life will be measured using the 23-item PedsQL 4.0 Generic49 questionnaire.