Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07077408

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Neurofibromatosis 1 Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Neoplastic Syndromes, Hereditary Nerve Sheath Neoplasms Nervous System Diseases Neurocutaneous Syndromes Neurodegenerative Diseases Neurofibroma Neurofibromatoses Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iCanCope-NF Youth app

Other

The iCanCope digital app offers symptom tracking, self-management skills training, goal setting, and disease education tailored for neurofibromatosis for youth.

iCanCope-NF Youth app + CM

Other

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.

Primary outcomes

  1. Feasibility of iCanCope NF

    Time frame: 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 outcomes

  1. Pain Interference

    Time frame: 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.

  2. Pain Severity

    Time frame: 8 weeks

    Pain severity will be measured using the 6-item validated Pain Scale from the PedsQL NF1 module.

  3. Pain management

    Time frame: 8 weeks

    Pain management is assessed will be measured using the 2-item validated Pain Management Scale from the PedsQL NF1 module

  4. Depressive symptoms

    Time frame: 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.

  5. Anxiety

    Time frame: 8 weeks

    Anxiety will be assessed using the validated 10-item Worry Scale from the PedsQL NF1 Module.

  6. Transition readiness

    Time frame: 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)

  7. Health-related quality of life

    Time frame: 8 weeks

    Health-related quality of life will be measured using the 23-item PedsQL 4.0 Generic49 questionnaire.

Study contacts

Contact information is provided by the study sponsor or research team.

Lauren Harris, MSc(OT)

CONTACT

[email protected]

416-813-7654

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • University Health Network, Toronto

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2025
Registry last updated
Jul 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.