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

NCT07077408 | Not Yet Recruiting

• 1 other identifier: 1000081822
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Neurofibromatosis 1

Outcome Measures

Primary Outcomes (1)

• Feasibility of iCanCope NF

  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.

  8 weeks

Secondary Outcomes (7)

• Pain Interference

  8 weeks

• Pain Severity

  8 weeks

• Pain management

  8 weeks

• Depressive symptoms

  8 weeks

• Anxiety

  8 weeks

Study Arms (3)

iCanCope-NF Youth

ACTIVE COMPARATOR

This group will receive access to the intervention on their personal smart phone, or a loaned study phone and charger, for a period of 2 months.

Other: iCanCope-NF Youth app

iCanCope-NF Youth with Contingency Management (CM)

EXPERIMENTAL

This group (iCanCope+CM) will receive access to the intervention on their personal smart phone, or a loaned study phone, for a period of 2 months. In addition to the standardized orientation and push notifications, this group will also be able to earn incentives aligned with their program engagement.

Other: iCanCope-NF Youth app + CM

Wait-list control

NO INTERVENTION

This group will continue to receive their usual care for 2 months. After completion of their follow-up outcome measures, they will be offered access to the iCanCope-NF Youth program. Participants will be reminded they should us their usual emergency care channels during the study if needed. iCanCope does not replace usual care. If participants need physical or mental health support during the study, they will be directed to resources within their community, primary care provider, specialist, or urgent care/emergency care.

Interventions

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

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.

iCanCope-NF Youth with Contingency Management (CM)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Moderate to severe cognitive impairments that would prevent independent use the iCanCope intervention, as determined through consultation with their health care provider

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• University Health Network, Toronto: collaborator

MeSH Terms

Conditions

Neurofibromatosis 1

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lauren Harris, MSc(OT)

CONTACT

416-813-7654; lauren.harris@sickkids.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinded data analysis will be conducted by an independent biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Model Details: A three-arm, parallel group, pilot randomized controlled trial will be conducted.

Study Record Dates

• First Submitted: July 3, 2025
• First Posted: July 22, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share