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

• ClinicalTrials.gov Identifier: NCT04561765
• Recruitment Status: Recruiting
• First Posted: September 24, 2020
• Last Update Posted: March 5, 2021
• Sponsor: Yale University
• Collaborators: United States Department of Defense; The Hospital for Sick Children; Connecticut Children's Medical Center
• Information provided by (Responsible Party): Frank D Buono, PHD, Yale University

Study Description

Brief Summary:

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 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.

Condition or disease	Intervention/treatment	Phase
Neurofibromatosis 1; Chronic Pain	Device: iCanCope; Device: iCanCope+Contingency Management	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Intervention Model Description: A 1x3 pilot randomized control trial (RCT) (iCanCope-NF, iCanCope-NF +Contingency Management (CM), Control Group) will be conducted with 108 adults with NF1 who suffer from pain.
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Innovation in the Treatment of Persistent Pain in Adults With NF1: Implementation of the iCanCope Mobile Application- Clinical Trial
• Actual Study Start Date: March 1, 2021
• Estimated Primary Completion Date: July 30, 2022
• Estimated Study Completion Date: August 1, 2022

Arms and Interventions

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: iCanCop+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.

Outcome Measures

Primary Outcome Measures :

1. Engagement Activity [ Time Frame: through the completion of the study, on average 4 months. ]
   Total minutes logged on the mobile application will be evaluated between the two groups using the mobile application.
2. Pain Severity [ Time Frame: through the completion of the study, on average 4 months. ]
   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.
3. Pain Interference Index [ Time Frame: through the completion of the study, on average 4 months. ]
   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.

Secondary Outcome Measures :

1. Treatment Services Review [ Time Frame: through the completion of the study, on average 4 months. ]
   what are perceptions of satisfaction across groups exposed to the iCanCope mobile application using an The Treatment Services Review (TSR)
2. Anxiety [ Time Frame: through the completion of the study, on average 4 months. ]
   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)
3. Sleep functioning [ Time Frame: through the completion of the study, on average 4 months. ]
   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
4. Short Form/Quality of Life [ Time Frame: through the completion of the study, on average 4 months. ]
   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.
5. Chronic pain acceptance [ Time Frame: through the completion of the study, on average 4 months. ]
   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. Higher scores indicate higher levels of acceptance
6. psychological inflexibility [ Time Frame: through the completion of the study, on average 4 months. ]
   Psychological Inflexibility in Pain Scale (PIPS) 16-item scale used to assess psychological inflexibility (i.e. avoidance, acceptance, fusion, values orientation, dirty discomfort) 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). Higher scores indicate greater levels of psychological inflexibility.

Other Outcome Measures:

1. Mindfulness based alternative approaches (MBAA) [ Time Frame: through the completion of the study, on average 4 months. ]
   Do individuals with NF1 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). Participants rated the items on a five-point Likert scale (1 = never or very rarely true to 5 = very often or always true), each facet score ranges from 8 to 40, except for the non-reactive facet which ranges from 7 to 35.

Eligibility Criteria

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

Criteria

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)

Contacts and Locations

Contacts

Contact: Frank D Buono, PhD; 8478496007; frank.buono@yale.edu

Locations

United States, Connecticut

Frank D Buono, PHD; Recruiting

New Haven, Connecticut, United States, 06510

Contact: Frank D Buono, PhD 847-849-6007 frank.buono@yale.edu

Sponsors and Collaborators

Yale University

United States Department of Defense

The Hospital for Sick Children

Connecticut Children's Medical Center

More Information

• Responsible Party: Frank D Buono, PHD, Associate Research Scientist, Yale University
• ClinicalTrials.gov Identifier: NCT04561765
• Other Study ID Numbers: 2000029045
• First Posted: September 24, 2020
• Last Update Posted: March 5, 2021
• Last Verified: March 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: IPD will not be shared with other investigator. Only non-PHI/IPD will be shared.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Neurofibromatoses; Neurofibromatosis 1; Neurofibroma; Chronic Pain; Pain; Neurologic Manifestations; 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; Genetic Diseases, Inborn; Peripheral Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Neoplasms; Nervous System Neoplasms