Enhancing Connections-Palliative Care: A Cancer Parenting Program for Patients with Advanced Cancer and Their Children

加强联系-姑息治疗：针对晚期癌症患者及其子女的癌症育儿计划

• 批准号: 10438211
• 负责人: FRANCES Marcus LEWIS
• 金额: $ 74.31万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-06 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10438211
• 关键词: Advanced Malignant Neoplasm; Affect; Age; Anxiety; Behavioral; Bereavement; Cancer Center; Child; Child Rearing; Competence; Comprehensive Cancer Center; Control Groups; Data; Depressed mood; Development; Diagnosis; Disadvantaged; Educational Intervention; Educational workshop; Emotional; Enrollment; Environment; Equation; Factor Analysis; Family; Goals; Hawaii; Health; Home; Individual; Informed Consent; Intervention; Intervention Studies; Interview; Knowledge; Language; Life; Malignant Neoplasms; Measures; Mission; Modeling; National Cancer Institute; National Institute of Nursing Research; Newly Diagnosed; Oncology; Outcome; Outcome Study; Palliative Care; Pamphlets; Parent-Child Relations; Parenting Education; Parents; Participant; Patient Education; Patients; Personal Communication; Persons; Phase; Protocols documentation; Quality of life; Randomized; Randomized Controlled Trials; Recurrent disease; Reduce health disparities; Research Priority; Sampling; Self Efficacy; South Carolina; Symptoms; TNM; Tail; Telephone; Testing; Theoretical model; Time; Training; Treatment Efficacy; Treatment Failure; Treatment outcome; United States; Universities; Washington; Workplace; Writing; advanced disease; alternative treatment; anxious; base; cancer care; coping; design; efficacy testing; emotional adjustment; evidence base; experimental group; improved; parent-child communication; pilot test; primary endpoint; primary outcome; programs; psychosocial; racial and ethnic; racial health disparity; recruit; response; service providers; skills; skills training; social cognitive theory; telephone delivery; theories; trauma exposure; tumor; virtual

PROJECT SUMMARY/ABSTRACT The purpose of the proposed study is to test the short-term efficacy of a cancer parenting education program for child-rearing parents diagnosed with non-curable cancer, called Enhancing Connections-Palliative Care Program (EC-PC). The program consists of fully scripted intervention sessions that will be delivered by telephone by a specially trained patient educator. The EC-PC has been pilot tested and is ready for efficacy testing. Parents will be eligible if they are diagnosed with non-curable cancer [determined by TNM Stage IV cancer for hard tumors or 2 or more cycles of treatment failure with disease relapse in non-solid tumors]; read, write and speak English as one of their languages of choice; have a child between the ages of 5-17 living in the home at least 50% of the time with the ill parent and another non-ill parent or parent surrogate; and have access to a telephone. Study participants will be recruited from 4 study centers: University of Washington/ Seattle Cancer Care Alliance; Georgetown University/ Lombardi Comprehensive Cancer Center; University of Hawaii/ Hawai’i Cancer Center, and Southeast Oncology/University of South Carolina. After completing signed informed consent and baseline measures, parents will be randomized to an experimental or alternative treatment control group. The experimental group will receive 5 telephone-delivered educational sessions every 2 weeks by specially trained patient educators. The control group will be mailed “What Should I Say to the Children?”, a guide for parents with advanced cancer, and be phone contacted by a specially trained patient educator who will use a script to guide the parent on ways to gain the most information from the booklet. Primary endpoints for testing efficacy will be assessed at 3-months post-baseline using Linear Mixed Models using an intent to treat analysis and a per-protocol analysis. Five primary outcomes will assess efficacy: parents' anxiety and depressed mood; parents' skills in helping their child manage the toll of the parents' cancer; parents' self- efficacy in talking with their child about the child's cancer-related concerns; and the child's anxious/depressed mood. The stability of changes will be described and evaluated at 6- and 9-months. With estimated Effect sizes of .33-81 on the primary outcomes, the study will have greater than 0.80 power to detect a significant difference between the experimental and control group, p=.05 (2-tailed). Our sample for analysis will be 492 diagnosed parents and their 492 non-ill coinhabiting partners/parent surrogates of children ages 5-17. In addition to testing efficacy, the proposed study will test the theoretical model of the intervention using structural equation modeling with confirmatory factor analysis; evaluate the impact of the intervention on children’s behavioral-emotional adjustment whose parents die during the study using Linear Mixed Models on data obtained from the non-ill parent; and examine the moderating effects of parents' symptom burden and family environment on treatment outcomes using Linear Mixed Models.

项目摘要/摘要 拟议的研究的目的是测试癌症育儿教育的短期效率 针对诊断出患有不可治疗癌症的儿童父母的计划，称为增强连接 - 帕利亚特 护理计划（EC-PC）。该计划由完全脚本的干预会议组成 由特殊训练有素的患者教育者致电。 EC-PC已进行了试点测试，并已准备好高效 测试。如果父母被诊断出患有不易疗法的癌症[由TNM IV确定 硬性肿瘤的癌症或非固体肿瘤中疾病缓解的治疗失败的2个或更多周期]；读， 写和说英语作为他们首选的语言之一；在5-17岁之间有一个孩子 至少有50％的时间与生病的父母和另一个非国际刑事父母或父母代理；并可以访问 电话。研究参与者将从4个研究中心招募：华盛顿大学/西雅图大学 关怀联盟；乔治敦大学/伦巴第综合癌症中心；夏威夷大学/夏威夷大学 癌症中心和东南肿瘤学/南卡罗来纳大学。完成签名的知情后 同意和基线措施，父母将被随机分为实验或替代治疗控制 团体。实验组将每2周每2周接受一次电话交付的教育课程 特殊训练的患者教育者。对照组将邮寄“我应该对孩子说些什么？”，一个 患有晚期癌症父母的指南，并由受过特殊训练的患者教育者联系 将使用脚本来指导父母获取手册中获取最多信息的方法。主要终点 对于测试效率，将在3个月后使用线性混合模型在3个月后使用意图来评估 治疗分析和每个协议分析。五个主要结果将评估效率：父母的动画和 心情沮丧；父母帮助孩子管理父母癌症的损失的技能；父母的自我 与孩子谈论孩子与癌症有关的问题的功效；和孩子的焦虑/沮丧 情绪。变化的稳定性将在6个月和9个月中进行描述和评估。估计效应大小 在主要结果上，该研究将具有0.80的功率，以检测出显着的能力 实验组和对照组之间的差异，p = .05（2尾）。 我们的分析样本将为492个被诊断的父母及其492个非ill共同合作伙伴/父母 5-17岁儿童的代理人。除了测试有效性外，拟议的研究还将测试理论 使用结构方程建模和确认因子分析的干预模型；评估 干预对儿童行为情感调整的影响，其父母在研究期间死亡 使用线性混合模型对从非IL-Il-ill parts获得的数据进行使用；并检查调节作用 父母的符号Burnen和家庭环境在使用线性混合模型的治疗结果上。