Message-Based Communication Outreach Intervention in Engaging Ovarian Cancer Survivors and Relatives to Consider Genetic Screening Services

Active:	Yes
Cancer Type:	Gynecologic Cancers Ovarian Cancer Primary Peritoneal Cancer Unknown Primary	NCT ID:	NCT04927013
Trial Phases:		Protocol IDs:	RSPH4984-20 (primary) NCI-2020-02281 STUDY00000224
Eligibility:	25 Years and older, Female	Study Type:	Screening
Study Sponsor:	Emory University Hospital/Winship Cancer Institute
NCI Full Details:	http://clinicaltrials.gov/show/NCT04927013

Summary

This trial studies how well a message-based communication outreach intervention works in engaging ovarian cancer survivors and their relatives to consider genetic screening services. This study may help the researchers identify best methods to engage cancer survivors and at-risk relatives to provide education regarding screening tools such as genetic testing. By providing outreach interventions, patients may develop a broader knowledge base, competence and confidence about genetic testing, which may improve future patient outcomes.

Objectives

PRIMARY OBJECTIVES:
I. To enlist community partners as citizen scientists to: identify and recruit Georgia residents with a personal/family history of ovarian cancer, generate content, and collaborate on a scalable message-based outreach intervention to reach ovarian cancer survivors and close relatives (i.e., first- and second-degree relatives) to consider genetic service options.
II. To compare a message-based outreach intervention to standard outreach for effects on: survivor reach, relative reach, and uptake of appropriate cancer genetic services (i.e., genetic counseling and testing for survivors, online genetic risk assessment for relatives) among survivors of ovarian cancer identified via a state cancer registry.
III. To conduct a process evaluation consistent with the Reach Effectiveness Adoption Implementation Maintenance (RE-AIM) framework alongside the randomized controlled trial (RCT) to measure: reactions, dose delivered/received, fidelity, acceptability, barriers/facilitators, and alignment with ethical principles.

OUTLINE:

PHASE I: Patients and family member participate in working groups to develop targeted letters, choice options for relative outreach, content for an interactive website, and short cueing messages that engage ovarian cancer survivors and their at-risk relatives in considering genetic risk assessment.

PHASE II: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive a standard letter and login information for condensed version of website that includes information on genetic risk and genetic counseling, patient navigators in their locale, and the importance of conveying information to close relatives. Patients also receive 2 extra letters and login information for 2 close relative.

GROUP II: Patients receive a letter with targeted messages and unique login information for expanded website. Patients also receive 2 text messages at 3-week intervals over a 6-week time period. Patients choice relatives may also receive a letter with targeted messages, and unique login information for an expanded website.

THE THINK ALOUD SUBSTUDY: Patients receive access to YourFamilyConnects website to review content and attend a one-on-one interview over 90 minutes on study.

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.