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

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.