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.

癌症儿童及其家庭的心理社会需求和风险在 文献，包括父母痛苦的风险增加，创伤后压力和焦虑。存在一个临界 需要为癌症儿童的父母和照顾者提供循证的心理社会护理（PCCC）， 尽管在亲自干预递送方面存在许多挑战。电子保健干预措施是一种 令人兴奋的潜在机会，以解决许多障碍，在人的干预交付，在这方面， 人口，但尚未广泛用于儿科心理社会癌症护理。COVID-19疫情 进一步阐明了需要灵活、可接受和可获得的电子卫生心理社会干预措施。的 电子癌症生存能力干预计划（eSCCIP）是一项创新的电子健康干预计划 通过自我指导互动式在线内容和远程保健后续行动相结合的方式提供 心理医生eSCCIP旨在减少急性痛苦、焦虑和创伤后应激的症状 同时，通过灵活、方便的方式提供循证治疗内容， 可访问的电子健康工具。干预措施提供给每个家庭的一个或两个PCCC，但内容的设计， 适用于整个家庭系统。eSCCIP基于认知行为和家庭系统的原则 治疗和改编自两个有效的亲自干预的照顾者的癌症儿童， 癌症生存能力干预计划（SCCIP）和癌症生存能力 干预计划-新诊断（SCCIP-ND）。eSSCIP通过严格的 开发过程涉及与PCCC的密切合作，内容专家在 儿科肿瘤学和电子健康，以及网页设计和开发专家。西班牙语改编的 eSCCIP，即帕拉肿瘤超级干预（eSCCIP-SP）， 最近经过严格的程序开发，现在也准备好进行测试。自导式 eSCCIP/eSCCIP-SP的在线模块包含教学视频内容、新颖的多家庭视频 以癌症儿童家长为对象的讨论小组，以及动手互动活动。试点测试是 目前正在进行中，并取得了可喜的初步成果。拟议研究的目的是测试 eSCCIP/eSCCIP-SP在严格的多中心RCT中与教育对照条件进行比较。主 研究终点是从基线到干预后急性痛苦的减少，次要终点 重点是减少创伤后应激和焦虑症状，改善自我应对能力， 有效性和认知应对。将在三个时间点（基线、干预后和三个时间点）收集数据。 月随访）。另一个探索性目标将侧重于实施战略和潜力 eSCCIP/eSCCIP-SP的成本和成本节约，为未来的试验奠定基础，重点是 传播和实施、分级护理模式和干预措施的完善。