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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

基本信息

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
项目类别：
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

项目摘要

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.

项目总结/文摘