iCanCope with Sickle Cell Pain: Design of a randomized controlled trial of a smartphone and web-based pain self-management program for youth with sickle cell disease

• Authors: Tonya M. Palermo, University of Washington; William T. Zempsky, University of Connecticut; Carlton D Dampier, Emory University; Chitra Lalloo, Hospital for Sick Children; Amos S. Hundert, Hospital for Sick Children; Lexa K. Murphy, Seattle Children's Research Institute; Nitya Bakshi, Emory University; Jennifer N. Stinson, Hospital for Sick Children
• Journal Title: Contemporary Clinical Trials
• Volume: Volume 74
• Publisher: Elsevier: 12 months | 2018-11-01, Pages 88-96
• Type of Work: Article | Post-print: After Peer Review
• Publisher DOI: http://doi.org/10.1016/j.cct.2018.10.006
• Subjects: Health Sciences, Medicine and Surgery; Health Sciences, Health Care Management
• Keywords: Science & Technology; Life Sciences & Biomedicine; Medicine, Research & Experimental; Pharmacology & Pharmacy; Research & Experimental Medicine; Sickle Cell Disease; Pain; Pain management; Cognitive-behavioral therapy; Smartphone application; HEALTH-CARE; CHILDREN; ADOLESCENTS; INTERVENTIONS; ADULTS; METAANALYSIS; VALIDATION; INSTRUMENT; OUTCOMES; THERAPY

Abstract

Many adolescents with sickle cell disease (SCD) experience recurrent and chronic pain, which has a negative impact on their health-related quality of life (HRQL). Cognitive-behavioral therapy (CBT) interventions can lead to improvement in pain and HRQL, yet due to barriers to care, most youth with SCD will not receive these interventions. To address this need for innovative programs targeting youth with SCD pain, we developed iCanCope, a tailored smartphone and web-based program that delivers a pain self-management intervention to youth with SCD. We describe the rationale, design, and implementation of a three-site parallel group randomized controlled trial with a sample of 160 adolescents with SCD and their parent caregivers. The iCanCope program includes pain self-management skills training (personalized CBT-based coping skills such as deep breathing, relaxation, and cognitive skills), goal setting, and social support. The attention control group is provided with access to a self-guided website with education about SCD. Assessments will occur at baseline (T1), immediately after completion of the intervention (12 weeks; T2) and at 6 months post-intervention (T3). Primary outcomes include coping strategies and pain intensity; secondary outcomes include physical, social, and emotional functioning, treatment satisfaction, health service use and caregiver response to youth pain behavior. Potential mediators (goal setting, self-management, and perceptions of social support) and moderators (e.g., demographic factors) will also be tested. The objective is to offer an effective, convenient, and low-cost psychosocial intervention to youth with SCD to enhance their self-management of pain.