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

NCT04561765 | Completed Results DMC

• 1 other identifier: 2000029045
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Neurofibromatosis 1; Chronic Pain

Outcome Measures

Primary Outcomes (3)

• 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 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.

• 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 Outcomes (7)

• Treatment Services Review

  through the completion of the study, on average 4 months.

• Anxiety

  through the completion of the study, on average 4 months.

• Sleep Functioning

  through the completion of the study, on average 4 months.

• Short Form/Quality of Life

  through the completion of the study, on average 4 months.

• Chronic Pain Acceptance

  through the completion of the study, on average 4 months.

Other Outcomes (1)

• Mindfulness Based Alternative Approaches (MBAA)

  through the completion of the study, on average 4 months.

Study Arms (3)

iCanCope

EXPERIMENTAL

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

iCanCope+Contingency Management

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

iCanCope DEVICE

The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases

iCanCope

iCanCope+Contingency Management DEVICE

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.

iCanCope+Contingency Management

Eligibility Criteria

• Age: 18 Years - 72 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Yale University: lead
• United States Department of Defense: collaborator
• The Hospital for Sick Children: collaborator
• Connecticut Children's Medical Center: collaborator

Study Sites (1)

Frank D Buono, PHD

New Haven, Connecticut, 06510, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Chronic Pain

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; 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; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Ondrej Blaha
• Organization: Yale University

ondrej.blaha@yale.edu

203.737.4468

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A 1x3 pilot randomized control trial (RCT) (iCanCope-NF, iCanCope-NF +Contingency Management (CM), Control Group) will be conducted with adults with NF1 who suffer from pain.

Study Record Dates

• First Submitted: September 10, 2020
• First Posted: September 24, 2020
• Study Start: March 1, 2021
• Primary Completion: September 6, 2022
• Study Completion: September 6, 2022
• Last Updated: March 30, 2025
• Results First Posted: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)