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

The Hospital for Sick Children

Status: Begins enrollment this month

Conditions: Neurofibromatosis 1

Treatments: Other: iCanCope-NF Youth app; Other: iCanCope-NF Youth app + CM

Study type: Interventional

Funder types: Other

Identifiers

NCT07077408

1000081822

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups

iCanCope-NF Youth

Active Comparator group

Description:

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.

Treatment:

Other: iCanCope-NF Youth app

iCanCope-NF Youth with Contingency Management (CM)

Experimental group

Description:

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.

Treatment:

Other: iCanCope-NF Youth app + CM

Wait-list control

No Intervention group

Description:

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.