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Educational and Informational Intervention for Advanced Cancer Parents (EC-PC Trial)

Seattle, WA

N/A

Recruiting

Led By Frances M Lewis, RN, MN, PhD, FAAN

Research Sponsored by University of Washington

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the efficacy of a 5-session, telephone-delivered cancer parenting program for child-rearing patients with non-curable cancer. It will 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.

See full description

Who is the study for?

This trial is for parents aged 23-68 with advanced, non-curable cancer who have a child between the ages of 5 and 17 living at home at least half the time. Participants must be able to read/write English, not be in hospice care, and have access to a phone. The non-ill co-parent must consent to participate.

What is being tested?

The study tests two educational programs aimed at improving quality of life and parenting confidence for those with late-stage cancer. It focuses on enhancing parent-child relationships and managing the impact of cancer on children.See study design

What are the potential side effects?

Since this trial involves educational and informational interventions rather than medical treatments, there are no direct physical side effects expected from participating in these programs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Child-Behavioral Emotional Functioning: Anxious/Depressed score on CBCL

Parent's confidence in being able to talk with her child about the child's cancer-related concerns (CASE Help Child Subscale)

Parents' skills in helping their child cope and manage the toll of the parents' cancer (Connecting and Coping Subscale)

+3 more

Secondary study objectives

Child's scores on the CBCL [Anxious/depressed score; Internalizing problems; Externalizing problems] for children whose parents die during the time of their participation in the study

Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Cohesion subscale

Effects of family's interpersonal environment on treatment outcomes: Family Environment Scale (FES) - Conflict subscale

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (enhancing connections-palliative care program)Experimental Treatment2 Interventions

Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

Group II: Group II (educational material)Active Control2 Interventions

Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

Do I qualify?Apply below to find out