CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 2,331 enrolled
Drug / intervention
Message-based Outreach Intervention for Survivors +3 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04927013
NCT04927013N/ACompleted

Testing a Low Cost Population- and Theory-Based Outreach Intervention to Engage Ovarian Cancer Survivors and Their Close Relatives to Consider Genetic Services

Emory University·interventional·Posted Jun 15, 2021·Updated Oct 3, 2024

In Brief

A clinical study evaluating Message-based Outreach Intervention for Survivors, Standard Outreach for Survivors, and 2 other interventions for Ovarian Cancer. Completed, enrolled 2,331 participants across 1 site.

Detailed Summary

This study tests a multi-component, low cost, message-based communication outreach intervention to engage ovarian cancer survivors and their at-risk relatives in considering cancer genetic services. The intervention includes foot-in-the-door techniques, tailored/targeted print, website support, and short messages to expand reach of prevention messages.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvarian Cancer
CountriesUnited States

Timeline

N/ACompletedFinished
20222023202420252026
First PostedJun 15, 2021
Enrollment StartJul 24, 2021
Primary CompletionFeb 21, 2023
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 5.0 years ago

Interventions

Message-based Outreach Intervention for Survivorsbehavioral

The Georgia Cancer Registry will mail the initial recruitment containing messages intended to persuade the survivor to visit the study website as well as a unique login to access the website. In addition to the components of the standard website, an expanded website for the Message-based group will include Guidance for Talking with Close Relatives about Their Cancer Risk, and the request to enumerate each close relative and choose from a menu of options about how the survivor would prefer for their relatives to be contacted. Survivors also can select the option that they prefer a relative not be contacted. In this case, no invitation letter will be generated for these relatives. Survivors who provide mobile phone numbers will receive two SMS thanking them for accessing the website, and encouraging them to revisit the website to review information and contact relatives. The messages will occur at 3-week intervals over a 6-week time period.

Standard Outreach for Survivorsbehavioral

The Georgia Cancer Registry will mail survivors an introductory letter modeled on the Registry's general outreach letters that will include log in information. Survivors will have access to a condensed version of the website that includes Information about Ovarian Cancer, Information about Who in Your Family is at Increased Risk, and the offer of Free Genetic Counseling with the option to schedule an appointment.

Message-based Outreach Intervention for Close Relativesbehavioral

Relatives will receive a unique website login linked to the survivor that enables access to the website. The website content will be identical to the survivor content with the exception of the addition of the Breast Cancer Genetics Referral Screening Tool (B-RST) risk assessment tool. This brief risk assessment is a validated screening tools that is clinically useful for estimating the probability of breast cancer (BRCA1/2) gene mutation and identifying women for referral to genetic counseling. Although all 1st or 2nd degree relatives of ovarian cancer survivors will screen positive on B-RST, asking relatives to complete the screener aims to raise their awareness of the factors that contribute to hereditary risk of ovarian cancer and will reinforce the salience of seeking genetic counseling. Additionally, relatives for who provide cell phone numbers will receive 3 SMS reminders over 9 weeks.

Standard Outreach for Close Relativesbehavioral

The invitation letter shared by the survivor will provide a unique login code for each relative to visit the standard website with sections specifically for relatives that include information about genetic risk, the value of completing an online short validated risk screener, and the offer of free genetic counseling with the option to schedule an appointment.