跳至主要内容
临床试验/NCT05294302
NCT05294302招募中不适用

A Randomized Controlled Trial of eSCCIP: An eHealth Psychosocial Intervention for English and Spanish Speaking Parents of Children With Cancer

Nemours Children's Clinic6 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2023年4月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
350
试验地点
6
主要终点
K-6

研究概览

简要总结

It is critical to provide accessible evidence-based psychosocial support to parents and caregivers of children with cancer (PCCC) in order to mitigate individual and family-level psychosocial risks. This effectiveness trial evaluates an eHealth intervention for English- and Spanish-speaking (PCCC) with study endpoints focused on decreasing negative psychosocial sequelae (acute distress, posttraumatic stress, and anxiety) and improving coping abilities (coping self-efficacy, cognitive coping strategies). The long-term goal of this research program is to sustain and disseminate an effective, scalable, high-reach, and cost-effective intervention to provide crucial support to PCCC across the pediatric cancer trajectory.

详细描述

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. P

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Investigators who are not delivering the intervention and the study biostatistician will be blinded to participant assignment.

入排标准

性别
All
接受健康志愿者

入选标准

  • Participants must be the parent or primary caregiver of a child (ages 0 - 18 years old) diagnosed with cancer.
  • Participants must be able to speak and read English or Spanish.
  • Participants must have access to the internet through a computer or mobile device (e.g., smartphone, tablet).

排除标准

  • PCCC are ineligible to participate if their child is not expected to live longer than six months from the time of potential recruitment

研究组 & 干预措施

eSCCIP/eSCCIP-SP

Active Comparator

The Electronic Surviving Cancer Competently Intervention Program (eSCCIP) is an innovative eHealth intervention that combines cognitive behavioral and family systems therapy to provide parents and caregivers of children with cancer (PCCC) with evidence-based coping skills and psychosocial support focused on the family unit. eSCCIP has three 30-minute, self-directed, online modules which feature a unique mix of original video content and interactive activities, supplemented by three telehealth follow-up sessions. A stakeholder-informed Spanish-language adaption of eSCCIP (eSCCIP-SP) has been developed and will be offered to Spanish-speaking PCCC. eSCCIP aims to reduce acute distress and symptoms of post-traumatic stress while increasing positive coping self-appraisal and use of cognitive coping skills.

干预措施: eSCCIP/eSCCIP-SP (Behavioral)

Coping Space

Active Comparator

PCCC randomized to the patient education control condition will be given access to a website with information about psychosocial functioning, coping, and PTSS related to pediatric cancer. This website will be hosted on the same platform as the intervention, available in English and Spanish, and will consist of information modified from CopingSpace.org. CopingSpace.org is an evidence-informed website developed by Ryan's Case for Smiles, a national organization dedicated to supporting families impacted by pediatric cancer and other chronic diseases.

干预措施: Coping Space (Behavioral)

结局指标

主要结局

K-6

时间窗: Up to 20 weeks

Questionnaire to measure acute distress.

次要结局

  • PCL-5(Up to 20 weeks)
  • The COVID-19 Exposure and Family Impact Scale (CEFIS)(Up to 20 weeks)
  • Multidimensional Scale of Perceived Social Support(Up to 20 weeks)
  • Coping Self-Efficacy Scale(Up to 20 weeks)
  • Cognitive Emotion Regulation Questionnaire(Up to 20 weeks)
  • Distress Thermometer(Up to 20 weeks)
  • PROMIS Short Form v1.0 - Anxiety - 8a(Up to 20 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kimberly Canter

Senior Research Scientist

Nemours Children's Clinic

研究点 (6)

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