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| Name | Class |
|---|---|
| University Health Network, Toronto | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Interference | measured by the 16-item Pain Impact Scale from the PedsQL NF1 module. This measures reflect how much pain hinders activity and functioning. | 8 weeks |
| Pain Severity | Pain severity will be measured using the 6-item validated Pain Scale from the PedsQL NF1 module. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Harris, MSc(OT) | Contact | 416-813-7654 | lauren.harris@sickkids.ca |
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A three-arm, parallel group, pilot randomized controlled trial will be conducted.
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Blinded data analysis will be conducted by an independent biostatistician
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| 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. |
|
| 8 weeks |
| Pain management | Pain management is assessed will be measured using the 2-item validated Pain Management Scale from the PedsQL NF1 module | 8 weeks |
| Depressive symptoms | 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. | 8 weeks |
| Anxiety | Anxiety will be assessed using the validated 10-item Worry Scale from the PedsQL NF1 Module. | 8 weeks |
| Transition readiness | 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) | 8 weeks |
| Health-related quality of life | Health-related quality of life will be measured using the 23-item PedsQL 4.0 Generic49 questionnaire. | 8 weeks |
| ID | Term |
|---|---|
| D009456 | Neurofibromatosis 1 |
| ID | Term |
|---|---|
| D017253 | Neurofibromatoses |
| D009455 | Neurofibroma |
| D018317 | Nerve Sheath Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D020752 | Neurocutaneous Syndromes |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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