A randomized controlled trial of eSCCIP: An eHealth psychosocial intervention for English and Spanish speaking parents of children with cancer

eSCCIP 的随机对照试验：针对英语和西班牙语癌症儿童父母的电子健康心理社会干预

• 批准号: 10560593
• 负责人: Kimberly Canter
• 金额: $ 63.17万
• 依托单位: ALFRED I. DU PONT HOSP FOR CHILDREN
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-02 至 2027-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10560593
• 关键词: Acute; Address; Anxiety; Behavioral; COVID-19 pandemic; Caregivers; Caring; Childhood; Childhood Cancer Treatment; Clinical; Cognitive; Collaborations; Communities; Consent; Consolidated Framework for Implementation Research; Coping Skills; Cost Savings; Data; Development; Dissemination and Implementation; Distress; Education; Electronics; Emotional; Family; Future; Goals; Grant; Health Personnel; Health Services Accessibility; Immigration; Impairment; Individual; Internet; Intervention; Interview; Language; Latino; Latino Population; Limited English Proficiency; Literature; Malignant Childhood Neoplasm; Malignant Neoplasms; Medical; Mental Depression; Modeling; Newly Diagnosed; Nursing Staff; Oncology; Outcome; Parents; Participant; Pattern; Pediatric Oncology; Persons; Phase; Population; Positioning Attribute; Predictive Factor; Predisposition; Process; Psychosocial Assessment and Care; Randomized, Controlled Trials; Recommendation; Research; Research Personnel; Risk; Risk Factors; Role; Self Direction; Self Efficacy; Site; Symptoms; System; Testing; Therapeutic; acceptability and feasibility; acute symptom; cancer care; cancer survival; caregiver interventions; coping; cost; cost effective intervention; cost estimate; design; eHealth; effectiveness trial; efficacy evaluation; efficacy testing; eligible participant; evidence base; flexibility; follow-up; health care disparity; implementation cost; implementation strategy; improved; innovation; interest; intervention delivery; intervention participants; intervention program; intervention refinement; low socioeconomic status; novel; pilot test; post intervention; post-traumatic stress; post-traumatic symptoms; programs; protective factors; psychosocial; reduce symptoms; secondary endpoint; social; sociodemographics; stressor; telehealth; tool; trial comparing; uptake; web site

The psychosocial needs and risks of children with cancer and their families are well-documented in the literature, including the 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), although many challenges exist regarding in-person intervention delivery. eHealth interventions represent an exciting potential opportunity to address many of the barriers to in-person intervention delivery in this population, but are not yet widely utilized in pediatric psychosocial cancer care. The COVID-19 pandemic has further illuminated the need for flexible, acceptable, and accessible eHealth psychosocial interventions. The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention for PCCC, delivered through a combination of self-guided interactive online content and telehealth follow-up with a therapist. eSCCIP aims to decrease symptoms of acute distress, anxiety, and posttraumatic stress while improving coping abilities by delivering evidence-based therapeutic content through a flexible, easily accessible eHealth tool. The intervention is delivered to one or two PCCC per family, but content is designed to apply to the whole family system. eSCCIP is grounded in principles of cognitive-behavioral and family systems therapy and is adapted from two efficacious in-person interventions for caregivers of children with cancer, the Surviving Cancer Competently Intervention Program (SCCIP) and the Surviving Cancer Competently Intervention Program – Newly Diagnosed (SCCIP-ND). eSSCIP has been rigorously developed through a stakeholder-engaged development process involving close collaboration with PCCC, content experts in pediatric oncology and eHealth, and web design and development experts. A Spanish language adaptation of eSCCIP, El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP), has recently been developed following a rigorous process and is now ready for testing as well. The self-guided online modules of eSCCIP/eSCCIP-SP feature a mix of didactic video content, novel multifamily video discussion groups featuring parents of children with cancer, and hands-on interactive activities. Pilot testing is currently underway with promising initial results. The objective of the proposed study is to test eSCCIP/eSCCIP-SP in a rigorous, multisite RCT compared to an education control condition. 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. Data will be collected at three timepoints (baseline, post-intervention, and three- month follow-up). 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.

癌症儿童及其家庭的心理社会需要和风险在《儿童健康报告》中有充分的记录