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Recruiting NCT07084168

Multimedia Aid for Genetic Testing in Gynecologic Oncology

No phase Interventional Ovary Cancer Endometrial Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational videos, Survey.
Who it may be relevant to
Registry conditions: Ovary Cancer, Endometrial Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This pilot study aims to estimate rates of genetic testing in patients with ovarian and endometrial cancer before and after the implementation of educational videos about genetic testing. Subjects will be asked to view one of three videos relevant to their cancer diagnosis and genetic testing, and have the option to complete a brief satisfaction survey. A chart review to evaluate rates of genetic testing ordered and referrals placed to Genetics before and after the implementation of the videos will be conducted. Up to 15-20% of ovarian cancer and 3-5% of endometrial cancer is due to inherited genetic mutation. Given this association, the National Comprehensive Cancer Network (NCCN) recommends genetic counseling and testing for all individuals with a diagnosis of ovarian cancer and endometrial cancer. Some challenges to obtaining genetic counseling and testing include missed identification and referral of eligible patients by providers, lack of provider knowledge, and busy clinic visits limiting time for informed consent and maintaining patient autonomy for genetic testing. Although heterogeneous, the literature supports multimedia use in cancer genetics. However, there is a paucity of data in the field of gynecologic oncology for the role of integrating a multimedia approach to genetic counseling.

Interventions

  • Behavioral Educational videos
    Educational videos about genetic testing will be provided. Subjects will be asked to view one of three videos (an endometrial cancer/Lynch Syndrome video or a longer or shorter version of an ovarian cancer video) relevant to their cancer diagnosis and genetic testing.
  • Behavioral Survey
    Subjects will be asked to complete a brief satisfaction survey.

Primary outcome measures

  • Proportion of genetic testing [Time frame: Baseline]
Secondary outcome measures (2)
  • Overall rates of genetic testing [Time frame: Baseline]
  • Patient satisfaction [Time frame: Baseline]

Eligibility criteria

Inclusion criteria

In order to participate in this study, a subject must meet all of the eligibility criteria outlined below.

  • Reviewed informed consent to participate in the study.
  • Subject is willing and able to comply with study procedures based on the judgment of the investigator.
  • Age ≥ 18 years at the time of consent.
  • Diagnosis of ovarian cancer or endometrial cancer
  • Eligible for genetic testing
  • English or Spanish is the primary language

Exclusion criteria

  • Previously completed genetic testing
  • Did not receive initial cancer-directed treatment at study site

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Univeristy of North Carolina at Chapel Hill — Chapel Hill

Identifiers

NCT: NCT07084168 · LCCC2417

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗