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

NCT ID: NCT07077408

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2027-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iCanCope-NF Youth

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.

Group Type: ACTIVE_COMPARATOR

iCanCope-NF Youth app

Intervention Type: 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 with Contingency Management (CM)

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.

Group Type: EXPERIMENTAL

iCanCope-NF Youth app + CM

Intervention Type: 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.

Wait-list control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iCanCope-NF Youth app

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

Intervention Type: OTHER

iCanCope-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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Stinson

Clinician Scientist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Lauren Harris, MSc(OT)

Role: CONTACT

lauren.harris@sickkids.ca

416-813-7654

Other Identifiers

1000081822

Identifier Type: -

Identifier Source: org_study_id