An interventional study of iCanCope and iCanCope+Contingency Management in Neurofibromatosis 1 and Chronic Pain, sponsored by Yale University. Completed at 1 site in United States. Open to participants aged 18 Years to 72 Years. Per ClinicalTrials.gov, last updated 2025-03-30.
Sponsored by Yale University · Not applicable, Interventional, and Treatment
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.
186 studies on the registry are indexed under Neurofibromatoses; 24 are open to participants now.
This study's enrollment of 122 is above the median of 26 across 120 interventional studies indexed under Neurofibromatoses.
Browse Neurofibromatoses studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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.
The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
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.
Engagement Activity
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through the completion of the study, on average 4 months.
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)
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: through the completion of the study, on average 4 months.
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.
Time frame: through the completion of the study, on average 4 months.
| Milestone | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Started | 40 | 42 | 40 |
| Completed | 38 | 36 | 34 |
| Not completed | 2 | 6 | 6 |
Average minutes per day logged on the mobile application will be evaluated between the two groups using the mobile application.
| minutes per day | iCanCope | iCanCope+Contingency Management |
|---|---|---|
| Engagement Activity | 4.7 ± 3.9 | 8.1 ± 6.5 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 4.743 ± 1.83 | 4.625 ± 2.17 | 4.787 ± 2.15 |
| Discharge (about 2 weeks) | 4.164 ± 1.99 | 3.778 ± 2.48 | 4.875 ± 2.65 |
| Follow-Up (on average 4 months) | 4.439 ± 2.01 | 4.160 ± 2.44 | 4.375 ± 2.47 |
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.
| T-score | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 57.709 ± 8.68 | 58.666 ± 7.92 | 59.394 ± 7.41 |
| Discharge (an average of 2 weeks) | 57.033 ± 7.45 | 54.965 ± 7.78 | 60.210 ± 9.21 |
| Follow-Up (on average 4 months) | 57.783 ± 8.04 | 56.366 ± 9.47 | 59.424 ± 9.73 |
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.
| themes | iCanCope + iCanCope- Contingency Management |
|---|---|
| User experience | 46 |
| Check-ins | 29 |
| Profile set up | 5 |
| Articles presented to the user by program | 40 |
| Trends presented to the user by the program | 27 |
| Goals presented to the user by the program | 37 |
| Improvement suggestions | 40 |
| Liked most | 36 |
| Liked least | 25 |
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)
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 7.865 ± 5.21 | 7.457 ± 4.56 | 8.412 ± 6.16 |
| Discharge (an average of 2 weeks) | 7.432 ± 5.24 | 5.667 ± 3.65 | 8.871 ± 6.48 |
| Follow-Up (on average 4 months) | 6.889 ± 4.77 | 6.861 ± 4.98 | 9.697 ± 5.67 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Sleep Functioning | 22.4 ± 6.4 | 22.2 ± 7.3 | 21.4 ± 8.2 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 9.342 ± 5.77 | 9.167 ± 5.02 | 10.500 ± 6.11 |
| Discharge (an average of 2 weeks) | 9.189 ± 5.24 | 8.500 ± 4.97 | 11.206 ± 6.54 |
| Follow-Up (on average 4 months) | 8.737 ± 4.84 | 9.556 ± 6.39 | 11.588 ± 6.37 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 65.517 ± 12.64 | 71.968 ± 11.26 | 70.148 ± 13.01 |
| Discharge (an average of 2 weeks) | 70.606 ± 11.58 | 72.333 ± 8.26 | 67.643 ± 12.19 |
| Follow-Up (on average 4 months) | 66.774 ± 9.51 | 70.462 ± 8.98 | 64.400 ± 13.30 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 26.361 ± 15.87 | 26.743 ± 13.28 | 25.061 ± 15.21 |
| Discharge (an average of 2 weeks) | 22.676 ± 13.26 | 22.639 ± 11.81 | 27.194 ± 16.70 |
| Follow-Up (on average 4 months) | 22.750 ± 13.56 | 22.735 ± 13.13 | 27.290 ± 14.58 |
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.
| score on a scale | iCanCope | iCanCop+Contingency Management | Control Group |
|---|---|---|---|
| Intake (Baseline) | 23.000 ± 6.75 | 25.000 ± 6.38 | 24.324 ± 7.48 |
| Discharge (an average of 2 weeks) | 21.833 ± 5.53 | 22.528 ± 6.58 | 23.844 ± 6.58 |
| Follow-Up (on average 4 months) | 20.108 ± 6.72 | 21.800 ± 7.02 | 22.938 ± 7.50 |
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.
| score on a scale | iCanCope | iCanCope+Contingency Management | Control Group |
|---|---|---|---|
| Mindfulness Based Alternative Approaches (MBAA) | 27.5 ± 3.9 | 28.2 ± 2.4 | 28.9 ± 2.5 |
Collected over 4 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| iCanCope | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| iCanCop+Contingency Management | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Control Group | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| Age, Continuous(years) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| Mean | 42.4 ± 12.9 | 40.9 ± 13.2 | 45.6 ± 10.5 | 42.4 ± 12.6 |
| Sex/Gender, Customized(Participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| Female | 27 | 30 | 28 | 85 |
| Male | 12 | 12 | 12 | 36 |
| Other | 1 | 0 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| American Indian or Alaskan | 0 | 0 | 1 | 1 |
| Asian | 1 | 2 | 0 | 3 |
| Black or African American | 2 | 4 | 4 | 10 |
| Other | 3 | 3 | 3 | 9 |
| White | 34 | 33 | 32 | 99 |
| Region of Enrollment(participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| United States | 40 | 42 | 40 | 122 |
| Marital Status(Participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| Divorced | 3 | 3 | 3 | 9 |
| Married | 13 | 15 | 20 | 48 |
| Other | 0 | 1 | 0 | 1 |
| Seperated | 2 | 0 | 0 | 2 |
| Single | 20 | 22 | 17 | 59 |
| Widowed | 1 | 1 | 0 | 2 |
| MIssing | 1 | 0 | 0 | 1 |
| Degree(Participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| Advanced | 4 | 4 | 5 | 13 |
| Associates | 9 | 8 | 3 | 20 |
| Bachelors | 10 | 13 | 9 | 32 |
| High School or GED | 10 | 7 | 11 | 28 |
| Some college | 6 | 7 | 8 | 21 |
| Technical schooling | 1 | 2 | 3 | 6 |
| Missing | 0 | 1 | 1 | 2 |
| Age at Diagnosis(years) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| Mean | 11.7 ± 13.1 | 10.3 ± 11.8 | 11.5 ± 12.2 | 11.2 ± 12.3 |
| Surgeries(Participants) | iCanCope | iCanCop+Contingency Management | Control Group | Total |
|---|---|---|---|---|
| 0 | 7 | 5 | 6 | 18 |
| 1 to 3 | 14 | 17 | 12 | 43 |
| 4 to 6 | 5 | 3 | 6 | 14 |
| 7 to 10 | 2 | 3 | 5 | 10 |
| 11 or more | 10 | 8 | 5 | 23 |
| Unknown or missing | 2 | 6 | 6 | 14 |
2 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data (IPD) will not be shared with other investigator. Only non-PHI/IPD will be shared.
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