NCT04759352

Telephone Versus In-person Post-test Cancer Genetic Counseling

Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 724 (estimated)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

Summary

The purpose of the GEO-STAR randomized non-inferiority trial is to compare the outcome of post-test telephone cancer genetic counseling with standard in-person cancer genetic counseling. We hypothesize that telephone counseling is non-inferior by outcome if compared to standard in-person counseling.

Detailed description

Consecutive patients undergoing pre-test cancer genetic counseling and cancer genetic testing, during the study period, will be eligible to participate. During the pre-test genetic counseling, demographic data, family and personal medical history will be collected and pedigree will be drawn. Available participants will provide written informed consent. They will be then randomized in blocks of ten participants using an online system (http://wwwservizi.regione.emilia-romagna.it/generatore/). The study is open label; thus, patients and investigators will not be blinded to treatment allocation due to the study nature intervention. After randomization, participants will be scheduled for post-test genetic counseling session. Participants randomized to usual care will receive standard in-person result disclosure. Participants randomized to telephone counseling will be scheduled for telephone post-test counseling sessions. One-week after completing the post-test genetic counseling session, the survey package will be sent by email to participants to assess impact and satisfaction with post-test counseling. Genetic counselors delivering post-test genetic counseling will complete the questionnaire immediately after the post-test session.

Conditions

• Cancer Gene Mutation

Interventions

Type	Name	Description
OTHER	Post-test genetic counseling delivered by telephone	Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.

Timeline

• Start date: 2021-05-15
• Primary completion: 2025-04-30
• Completion: 2025-04-30
• First posted: 2021-02-18
• Last updated: 2021-07-28

Locations

1 site across 1 country: Italy