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Educational and Informational Intervention for Advanced Cancer Parents (EC-PC Trial)
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
EC-PC Trial 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.
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.Check my eligibility
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.
EC-PC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreEC-PC 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.
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Who is running the clinical trial?
National Institute of Nursing Research (NINR)NIH
580 Previous Clinical Trials
10,374,971 Total Patients Enrolled
3 Trials studying Parenting
462 Patients Enrolled for Parenting
University of WashingtonLead Sponsor
1,740 Previous Clinical Trials
1,846,080 Total Patients Enrolled
3 Trials studying Parenting
649 Patients Enrolled for Parenting
Frances M Lewis, RN, MN, PhD, FAANPrincipal InvestigatorUniversity of Washington
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a parent with late-stage cancer that cannot be cured.I have a child aged 5-17 living with me at least half the time.I can use any type of therapy.I am a parent of a child aged 5-17.
Research Study Groups:
This trial has the following groups:- Group 1: Group II (educational material)
- Group 2: Group I (enhancing connections-palliative care program)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals currently being invited to participate in this investigation?
"Affirmative. Clinicaltrials.gov data attests to this clinical trial's current recruitment status, which began on the 1st of April 2022 and was updated most recently on the 25th July 2022. The study requires 795 individuals from a single medical site for participation."
Answered by AI
Is the geriatric population being considered for inclusion in this research trial?
"The age range for prospective participants in this study is bracketed by 23 and 68 years of age."
Answered by AI
How many participants are currently involved in this clinical trial?
"Affirmative. The study, which was initially published on April 1st 2022 and last modified on July 25th 2022 is actively seeking candidates. 795 individuals are expected to be enrolled from one site for the duration of this clinical trial."
Answered by AI
What criteria must an individual meet in order to participate in this research?
"To qualify for this research, volunteers must have a malignant diagnosis and be between 23 and 68 years of age. Thus far, 795 patients are being sought out for the study."
Answered by AI
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