Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 9, 2023
Date Accepted: Mar 5, 2023
A Randomized Controlled Trial of the Electronic Surviving Cancer Competently Intervention Program (eSCCIP): Protocol for a Psychosocial Digital Health Intervention for English and Spanish-speaking Parents of Children with Cancer
ABSTRACT
Background:
The psychosocial needs and risks of children with cancer and their families are well-documented, including increased risk of parental distress, posttraumatic stress, and anxiety. There is a critical need to provide evidence-based psychosocial care to parents and caregivers of children with cancer (PCCC). Digital health interventions are important to address many barriers to in-person intervention delivery but are not widely utilized in pediatric psychosocial cancer care. The COVID-19 pandemic has reinforced the need for flexible, acceptable, and accessible psychosocial digital health interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative digital health intervention for PCCC, delivered through a combination of self-guided interactive online content and supplemented by three telehealth follow-up sessions with a trained telehealth guide. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has been developed. The self-guided online Cores of eSCCIP/eSCCIP-SP are a mix of didactic video content, multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities.
Objective:
The objective of this study is to test eSCCIP/eSCCIP-SP in a multisite RCT compared to an internet-based education control condition consisting of information specifically focused on concerns relevant to PCCC.
Methods:
Using a randomized controlled clinical trial design, 350 eligible PCCC will be randomly assigned to the intervention (eSCCIP/eSCCIP-SP) or an education control condition. Data will be collected at three time points: pre-intervention (prior to randomization), immediately post-intervention (after 6 weeks), and at three-month follow-up (from baseline). Participants randomized to either condition will receive study material (eSCCIP/eSCCIP-SP intervention or education control website) in English or Spanish, based on primary language spoken in the home and participant preference.
Results:
The primary study endpoint is a reduction in acute distress from baseline to post-intervention, with secondary endpoints focused on reductions in symptoms of posttraumatic stress and anxiety, and improvements in coping self-efficacy and cognitive coping. An additional, exploratory aim will be focused on implementation strategies and potential costs and cost-savings of eSCCIP/eSCCIP-SP, laying the groundwork for future trials focused on dissemination and implementation, stepped-care models, and intervention refinement.
Conclusions:
This trial will provide necessary data to evaluate the efficacy of eSCCIP/eSCCIP-SP. This intervention has potential to be an easily scalable and highly impactful psychosocial treatment option for PCCC. Clinical Trial: clinicaltrials.gov identifier: NCT05294302
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