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: 10364256
• 负责人: Kimberly Canter
• 金额: $ 68.33万
• 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/10364256
• 关键词: Acute; Address; Anxiety; Behavioral; COVID-19 pandemic; Cancer Survivor; 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; 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; Process; Psychosocial Assessment and Care; Randomized Controlled Trials; Recommendation; Research; Research Personnel; Risk; Risk Factors; Role; Self Efficacy; Self-Direction; Symptoms; System; Testing; Therapeutic; acute symptom; cancer care; 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.

癌症儿童及其家人的社会心理需求和风险在《 文献报道，包括父母痛苦、创伤后压力和焦虑的风险增加。 需要向癌症儿童的父母和照顾者（PCCC）提供基于证据的社会心理护理， 尽管电子医疗干预措施存在许多挑战。 令人兴奋的潜在机会，可以解决这一领域进行现场干预的许多障碍 人群，但尚未在儿科心理社会癌症护理中广泛使用。 进一步阐明了对灵活、可接受和可及的电子卫生心理社会干预措施的需求。 电子癌症生存干预计划 (eSCCIP) 是一项创新的电子健康干预措施 针对 PCCC，通过自助式交互式在线内容和远程医疗随访相结合的方式提供 eSCCIP 旨在减少急性痛苦、焦虑和创伤后应激症状。 同时通过灵活、轻松的方式提供基于证据的治疗内容来提高应对能力 该干预措施针对每个家庭的一两个 PCCC，但内容旨在 适用于整个家庭系统 eSCCIP 基于认知行为和家庭系统的原则。 疗法，改编自针对癌症儿童护理人员的两项有效的现场干预措施，即 癌症有效干预计划 (SCCIP) 和癌症有效干预 干预计划 – 新诊断 (SCCIP-ND) 是通过严格制定的。 利益相关者参与的开发流程涉及与 PCCC、内容专家的密切合作 儿科肿瘤学和电子医疗，以及网页设计和开发专家。 eSCCIP，El Programa Electronico de Intervencion para Superar Cancer Competentemente (eSCCIP-SP)，具有 最近经过严格的流程开发，现已准备好进行自我引导。 eSCCIP/eSCCIP-SP 的在线模块混合了教学视频内容、新颖的多家庭视频 由癌症儿童家长参加的讨论小组以及试点互动活动。 目前正在进行中，并取得了有希望的初步结果。拟议研究的目的是进行测试。 严格的多中心 RCT 中的 eSCCIP/eSCCIP-SP 与教育控制条件进行比较。 研究终点是从基线到干预后急性痛苦的减少，以及次要终点 重点是减少创伤后压力和焦虑症状，以及改善应对自我的能力 将在三个时间点（基线、干预后和三个时间点）收集数据。 一个月的后续行动）。 eSCCIP/eSCCIP-SP 的成本和成本节约，为未来的试验奠定基础 传播和实施、阶梯式护理模式以及干预细化。