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Clinical Trial Summary

This is a multi-site Phase 2, 2-group randomized control trial that will test the efficacy of a 5-session, telephone-delivered cancer parenting program for child-rearing patients with non-curable cancer. Aim 1: To assess the efficacy of the intervention on parents' and children's primary outcomes at 3 months using Linear Mixed Models within an intent to treat analysis and per protocol analysis. Aim 2: To test the underlying theoretical model of the intervention using structural equation modeling with confirmatory factor analysis. Aim 3: To examine the impact of the intervention on children's depressed mood, anxiety, and Internalizing and Externalizing problems whose parent dies during participation in the study. Aim 4: To examine the moderating effects of parents' symptom burden and family environment on treatment outcomes. After obtaining signed informed consent, participants will be randomized to the experimental or control group. Assessments will be obtained at baseline and at 3, 6, and 9-months post-baseline using standardized questionnaires. Parents randomized to the experimental group will receive the 5-session EC-PC Program at 2-week intervals delivered by telephone by specially trained patient educators. The control group will be mailed the booklet, "Having a Successful Conversation with Your Child," a guide for child-rearing parents with advanced cancer, and will receive a fully scripted phone call from a trained patient educator. Efficacy will be evaluated at 3-months post-baseline on 5 primary outcomes: child's depressed mood and anxiety; parents' depressed mood; parents' anxiety the parent's confidence in being able to talk with their child about the child's cancer-related concerns; and the parents' skills in helping their child cope and manage the toll of the parents' cancer. The stability of changes will be described and evaluated at 6- and 9-months.


Clinical Trial Description

This is a multi-site Phase 2, 2-group randomized control trial that will test the efficacy of a 5-session, telephone-delivered cancer parenting program for child-rearing patients with non-curable cancer. There are 4 study aims. Aim 1: To assess the efficacy of the intervention on parents' and children's primary outcomes at 3 months using Linear Mixed Models within an intent to treat analysis and per protocol analysis. Stability of changes will be described at 6 and 9 months follow up. Aim 2: To test the underlying theoretical model of the intervention using structural equation modeling with confirmatory factor analysis. Aim 3: To examine the impact of the intervention on children's depressed mood, anxiety, and children's behavioral-emotional problems whose parent dies during participation in the study. Aim 4: To examine the moderating effects of parents' symptom burden and family environment on treatment outcomes. A total of 795 diagnosed parents and 795 residential non-ill parents will be enrolled; allowing for attrition from all causes, our target sample for efficacy analysis will be 492 diagnosed parents. After obtaining signed informed consent, participants will be randomized to the experimental or control group. Assessments will be obtained at baseline and at 3, 6, and 9-months post-baseline using standardized questionnaires. Parents randomized to the experimental group will receive the 5-session EC-PC Program at 2-week intervals delivered by telephone by specially trained patient educators. The control group will be mailed the booklet, "Having a Successful Conversation with Your Child," a guide for child-rearing parents with advanced cancer, and will receive a fully scripted phone call from a trained patient educator. The scripted call is designed to help the parent gain knowledge of the content in the booklet but does not include skill-building or efficacy-enhancing exercises. Efficacy will be evaluated at 3-months post-baseline on 5 primary outcomes: child's depressed mood and anxiety ; parents' depressed mood; parents' anxiety; parents' confidence in being able to talk with their child about the child's cancer-related concerns; and the parents' skills in helping their child cope and manage the toll of the parents' cancer. The stability of changes will be described and evaluated at 6- and 9-months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05477784
Study type Interventional
Source University of Washington
Contact Ellen H Zahlis
Phone 206 550-8471
Email [email protected]
Status Recruiting
Phase N/A
Start date April 1, 2022
Completion date March 31, 2027

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