iCanCope With Sickle Cell Pain

Study Overview
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Brief Summary
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The project will test a tailored web and smartphone-based application (iCanCope with SCD) to improve pain self-management and functioning in youth (aged 12-18) with sickle cell disease. The program will include goal setting, peer-based social support, and pain self-management training. The investigators will determine initial program effectiveness through a pilot three-site randomized controlled trial in 160 youth randomized to treatment compared to attention control.

Detailed Description
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Cognitive-behavioral therapies (CBT) that promote pain self-management can lead to symptom reduction, improved quality of life, and decreased healthcare use. However, most people with SCD do not receive CBT-based treatment due to barriers such as poor accessibility, limited availability of professionals, and high costs. First, the investigators plan to apply a user-centered design approach to develop and refine the iCanCope with SCD program. Second, program feasibility and initial program effectiveness will be determined through a pilot three-site randomized controlled trial. The investigators will determine study accrual and dropout rates as well as levels of patient acceptability and engagement. Preliminary effectiveness will be determined in youth receiving treatment compared to attention control on a range of physical, behavioral, and psychosocial outcomes assessed at post-treatment and 6-month follow-up. Third, moderators and mediators of treatment effect will be tested by examining whether differences in self-efficacy and patient activation predict changes in pain and functioning. These results will enable a future full-scale randomized controlled trial.

Official Title
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iCanCope With Sickle Cell Disease: A Mobile Pain Management Intervention for Adolescents

Conditions
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Sickle Cell Disease

Intervention / Treatment
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* Behavioral: Pain self-management
* Behavioral: Education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged between 12-18 years diagnosed with any type of SCD able to speak and read English score at least 4 (indicating some days with pain interference over the past month) on the Sickle Cell Pain Burden Interview willing and able to complete online measures Exclusion Criteria: significant cognitive limitations that would impair their ability to use and understand the iCanCope with SCD program, as per their healthcare provider or parent have previously received more than 4 sessions of outpatient psychological therapy for pain management in the 6 months prior to the time of screening.

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Education Control<br>In addition to standard medical care, youth in the education control group will be provided with access to a self-guided education study website, which will contain static education about SCD (no self-management skills, goal-setting, or social support content) to access over 8-weeks. | Behavioral: Education<br>* Education about sickle cell disease to increase disease knowledge<br>|
| Experimental: Pain Self-Management Intervention<br>In addition to standard medical SCD care, youth in the pain self-management intervention group will receive the iCanCope with SCD mobile intervention including goal-setting, peer social support, and pain self-management skills over a period of 8 weeks. | Behavioral: Pain self-management<br>* The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.<br>Behavioral: Education<br>* Education about sickle cell disease to increase disease knowledge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Diary - Average Daily Pain | App diary using an 11-point numerical rating scale for pain intensity for 7 days Scores range from 0-10 where higher scores indicate a worse outcome | Baseline,12 weeks, and 26 weeks | 
| Pain Diary - Average Daily Activity Limitations | App diary using Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days Scores range from 0-100 where higher scores mean a worse outcome | Baseline,12 weeks, and 26 weeks | 
| Adaptive Coping - Coping Attempts | Coping Strategies Questionnaire for Sickle Cell Disease - Coping Attempts Factor Scores range from 0 - 180, higher scores mean a better outcome | Baseline,12 weeks, and 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Acceptability | Treatment Evaluation Inventory scores range from 9 - 45 where higher scores mean a better outcome | 2 months after starting treatment | 
| Physical and Emotional Functioning - Depressive Symptoms | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Depressive Symptoms T-score, higher scores means higher depressive symptoms. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of depressive symptoms. | Baseline,12 weeks, and 26 weeks | 
| Physical and Emotional Functioning - Anxiety | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Anxiety T-score, higher scores means higher levels of anxiety. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of anxiety. | Baseline,12 weeks, and 26 weeks | 
| Physical and Emotional Functioning - Mobility | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Mobility T-score, higher scores means better mobility. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical mobility limitations. | Baseline,12 weeks, and 26 weeks | 
| Physical and Emotional Functioning - Pain Interference | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Pain Interference T-score, higher scores means more pain interference. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of pain interference. | Baseline,12 weeks, and 26 weeks | 
| Physical and Emotional Functioning - Fatigue | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Fatigue T-score, higher scores means higher levels of fatigue. 50 indicates the population mean with a standard deviation of 10. A T-score of 60 is indicative of sub-clinical or elevated levels of fatigue. | Baseline,12 weeks, and 26 weeks | 
| Physical and Emotional Functioning - Peer Relationships | Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile v2.0 - Peer Relationships T-score, higher scores means better peer relationships. 50 indicates the population mean with a standard deviation of 10. A T-score of 40 is indicative of sub-clinical or reduced quality of peer relationships. | Baseline,12 weeks, and 26 weeks | 
| Patient Global Impression of Change | Global rating for improvement in pain and functioning Scores range from 1-7 where higher scores mean a better outcome | 12 weeks and 26 weeks | 
| Parent Protectiveness | Adult Responses to Children's Symptoms Scores range from 0-4 where higher scores mean a worse outcome | Baseline,12 weeks, and 26 weeks | 
| Health Services Utilization | Client Services Receipt Inventory adapted for sickle cell disease - Number of hospitalizations and/or ED visits | Baseline and 26 weeks | 
| Parent Psychological Distress | Symptom Checklist 90 - Global Severity Index Scores range from 0-4, with higher scores indicating a worse outcome | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Social Functioning | Bath Adolescent Pain Questionnaire - Parent version, Social Functioning (score range: 0-36). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Physical Functioning | Bath Adolescent Pain Questionnaire - Parent version Physical Functioning (0-36). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Depression | Bath Adolescent Pain Questionnaire - Parent version, Depression (0-24). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, General Anxiety | Bath Adolescent Pain Questionnaire - Parent version, General Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Pain Specific Anxiety | Bath Adolescent Pain Questionnaire - Parent version, Pain Specific Anxiety (0-28). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Family Functioning | Bath Adolescent Pain Questionnaire - Parent, Family Functioning (0-48). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Child Physical and Emotional Functioning - Parent Report, Development | Bath Adolescent Pain Questionnaire - Parent version, Development (0-44). A higher score indicates more impaired functioning for all subscales. | Baseline,12 weeks, and 26 weeks | 
| Treatment Experiences - Child | Self report of treatment experiences. The number of participants with high levels of increased stress or anxiety will be reported. | 12 weeks and 26 weeks |