iCanCope With Sickle Cell Pain

The Hospital for Sick Children, Emory University, Connecticut Children's Medical Center, University of Mississippi Medical Center, University of Florida, Boston Medical Center, Northwestern University

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.

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.

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.

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.

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.

App diary using an 11-point numerical rating scale for pain intensity and Child Activity Limitations Inventory 9-items to measure activity limitations for 7 days

Patient-reported Outcomes Measurement Information System (PROMIS) Pediatric Profile: depressive symptoms, anxiety, mobility, pain interference, fatigue, peer relationships

Bath Adolescent Pain Questionnaire - Parent version assesses social functioning (score range: 0-36), physical functioning (0-36), depression (0-24), general anxiety (0-28), pain specific anxiety (0-28), family functioning (0-48) and development (0-44). A higher score indicates more impaired functioning for all subscales.

Self report of adverse events during treatment. The number of participants with unwanted treatment effects will be reported.

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.

Lalloo C, Nishat F, Zempsky W, Bakshi N, Badawy S, Ko YJ, Dampier C, Stinson J, Palermo TM. Characterizing User Engagement With a Digital Intervention for Pain Self-management Among Youth With Sickle Cell Disease and Their Caregivers: Subanalysis of a Randomized Controlled Trial. J Med Internet Res. 2022 Aug 30;24(8):e40096. doi: 10.2196/40096.