Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial

Innovation in the Treatment of Persistent Pain in Adults With Neurofibromatosis Type 1 (NF1): Implementation of the iCanCope Mobile Application- Clinical Trial

To demonstrate the initial feasibility and determine preliminary impact on clinical outcomes of the iCanCope-NF program in a pilot RCT. If successful this pilot study will support conducting a larger randomized control trial (RCT). The primary research question is what is the feasibility of the iCanCope-NF program? The investigators define feasibility as (1) rates of accrual and dropout, daily log-ins, engagement, and outcome measures completed and (2) perceptions regarding intervention acceptability and satisfaction; and what are the levels of engagement. log-ins, with the intervention? The secondary questions are: (1) how does the iCanCope-NF program compare with the control condition in differences of pain and pain-related activity limitations, sleep functioning, emotional functioning (depression, anxiety), opioid usage, pain catastrophizing, self-efficacy, respondent burden (i.e. Physical Functioning, R, Vitality, Social Functioning, Role-Emotional, and Mental Health), and psychological flexibility immediately post-treatment (T2), (2) does the iCanCope-NF + CM increase the engagement of the iCanCope-NF program as compared to iCanCope-NF without CM, and do their corresponding levels of pain and pain-related activity decrease with CM?, and (3) do individuals with NF1 utilize the Mindfulness based alternative approaches (MBAA) to help reduce pain symptoms? The investigators hypothesize that by customizing and including MBAA to the program for adults with NF1, that individuals who engage regularly as seen through Analytics Platform for Evaluating Effective Engagement (APEEE) application, will acquire new sets of skills to facilitate pain management, while pain as reported with the Brief Pain Inventory will decrease.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Neurofibromatosis 1
• Intervention / Treatment: Device: iCanCope; Device: iCanCope+Contingency Management

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Frank D Buono, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 72 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• adults 18+
• able to read and understand English at 5th grade level
• permanently reside in the United States
• have pain interference aggregate scores of three or more in the last two weeks using the Brief Pain Inventory-Short Form (BPI-SF) scale

Exclusion Criteria:

• have an undiagnosed case of NF1
• have documented major co-occurring psychiatric disease
• have moderate to severe cognitive deficits
• have depression assessed using the Patient Health Questionnaire (PHQ-9) or anxiety assessed using the Generalized Anxiety Disorder scale (GAD-7) greater than or equal to the appropriate thresholds (10=mild major depression; 5=mild severe anxiety)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: iCanCope; In this group, individuals will receive the iCanCope-NF program. The intervention will be delivered on a restricted password-protected mobile application. Participants will be encouraged to log onto the pain diary app (via automated alerts) once per day over the 8-week period to complete pain diary entries and develop and track their goals related to their pain, physical, social activities, sleep, as well as work through content based on their goals.	Device: iCanCope; The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
Experimental: iCanCope+Contingency Management; In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.	Device: iCanCope+Contingency Management; In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
No Intervention: Control Group; The control group is designed to assess for potential effects on outcomes of time, attention, during the study. In addition to usual care, participants will be required to complete baseline and follow-up assessments similar to that of the intervention groups. They will be given that patient education, through preapproved flyers and information found from national websites regarding pain management, but no self-management strategies or opportunities for social support. They will not have access to the mobile application during the course of experiment; however, the control group will be offered the full iCanCope-NF program following the trial (T2) for a period of 2 months after the study is over.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Severity	A comparison within groups change of pain severity measured by the Brief Pain Inventory-Short Form. Respondents rate items on a 0-10 scale to indicate the pain severity and interference, and the total score is the mean of each subfactor. The higher the score indicates more severity and interference of pain.	through the completion of the study, on average 4 months.
Engagement Activity	Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.	through the completion of the study, on average 4 months.
Pain Interference Index	A comparison within groups change of pain interference measured by the Pain Interference Index Scale. Respondents rate items on a 0-6 scale to indicate how much pain has interfered with various activities, and the total score is the mean of the six items. Where 6 indicates high interference. Presented here are the non-linear converted T scores with a 'population' mean of 50 and standard deviation of 10. Scores above 50 indicate more pain interference.	through the completion of the study, on average 4 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety	A comparison within change of generalized anxiety measured by the generalized anxiety disorder scale (GAD-7). After reading each statement, one of four choices are provided and respondents can select one response (1=not at all sure, 2=several days, 3=over half days, 4=nearly every day). Each column is then added, and a total score is obtained, with scores falling into four levels of anxiety, including minimal (1-4), mild (5-9), moderate (10-14), and severe (15-21)	through the completion of the study, on average 4 months.
Short Form/Quality of Life	the Short form survey 20- will measure quality of life across 8 subscales on respondent burden (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health). Scores were transformed linearly to 0-100 scales, with 0 and 100 assigned to the lowest and highest possible scores, where high value indicated better functioning.	through the completion of the study, on average 4 months.
Treatment Services Review	What are perceptions of satisfaction across groups exposed to the iCanCope mobile application using an The Treatment Services Review (TSR). Data presented here represents the themes that emerged from the qualitative interviews.	through the completion of the study, on average 4 months.
Sleep Functioning	A comparison within change of sleep quality measured by the PROMIS Sleep inventory. The higher the total score, the more severe the symptom. Total scores less than 24 suggest no to slight sleep disturbance, 24-28 suggest mild disturbance, 29-38 moderate disturbance, and greater than 38 severe sleep disturbance. The score has a range of 0 to 40.	through the completion of the study, on average 4 months.
Chronic Pain Acceptance	Chronic Pain Acceptance Questionnaire-Revised (CPAQ-Revised) 20-item scale designed to measure acceptance of pain. The acceptance of chronic pain is thought to reduce unsuccessful attempts to avoid or control pain and thus focus on engaging in valued activities and pursuing meaningful goals will be measured across all groups. The items on the CPAQ are rated on a 7-point scale from 0 (never true) to 6 (always true). To score the CPAQ, add the items for Activity engagement and Pain willingness to obtain a score for each factor. To obtain the total score, add the scores for each factor together. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.	through the completion of the study, on average 4 months.
Psychological Inflexibility in Pain Scale: Avoidance	Psychological Inflexibility in Pain Scale (PIPS) Avoidance subscale is a 10-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for the Avoidance subscale is 10-70. The PIPS outcome was originally registered as a single item.	through the completion of the study, on average 4 months.
Psychological Inflexibility in Pain Scale: Cognitive	Psychological Inflexibility in Pain Scale (PIPS) Cognitive subscale is a 6-item scale used to assess psychological inflexibility in people with chronic pain will be measured across all groups. Respondents are asked to rate items on a 7-point scale that ranges from 1 (never true) to 7 (always true). The total score was calculated by summing the responses for each of the items. Higher scores indicate greater levels of psychological inflexibility. Total score range for Cognitive subscale is 6-42. The PIPS outcome was originally registered as a single item.	through the completion of the study, on average 4 months.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness Based Alternative Approaches (MBAA)	Do individuals with NF-1 utilize the MBAA more readily because they are on the mobile application, via Five Facet Mindfulness Questionnaire. 39-item self-completed questionnaire measuring the five facets of mindfulness: Observing (8 items), Describing (8 items), Acting with awareness (8 items), Non-judgmental (8 items), and Non-reactive (7 items). Total score ranges from 8 to 40. Higher scores indicating greater mindfulness.	through the completion of the study, on average 4 months.

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: The Hospital for Sick Children; United States Department of Defense; Connecticut Children's Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): September 6, 2022
• Study Completion (Actual): September 6, 2022

Study Registration Dates

• First Submitted: September 10, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 24, 2020

Study Record Updates

• Last Update Posted (Actual): March 30, 2025
• Last Update Submitted That Met QC Criteria: March 27, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neoplasms; Neuromuscular Diseases; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neoplasms by Histologic Type; Neurodegenerative Diseases; Neoplasms, Nerve Tissue; Nervous System Neoplasms; Heredodegenerative Disorders, Nervous System; Nerve Sheath Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Peripheral Nervous System Neoplasms; Chronic Pain; Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
• Other Study ID Numbers: 2000029045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be shared with other investigator. Only non-PHI/IPD will be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No