Telephone Versus In-person Post-test Cancer Genetic Counseling (GEO-STAR)

Scientific Institute for Research Hospitalization and Healthcare (IRCCS)

Status: Enrolling

Conditions: Cancer Gene Mutation

Treatments: Other: Post-test genetic counseling delivered by telephone

Study type: Interventional

Funder types: Other

Identifiers

NCT04759352

GEO-STAR

Details and patient eligibility

About

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.

Full 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.

Enrollment: 724 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients over 18 years of age inclusive at the time of the study;
• Patients must have undergone an in-person pre-test genetic counseling session;
• Patients must have undertaken cancer genetic testing;
• Patients must be able to speak Italian fluently;
• Patients must have got an email address.

Exclusion criteria

• Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

724 participants in 2 patient groups

Telephone post-test genetic counseling

Experimental group

Description:

Post-test genetic counseling delivered by telephone

Treatment:

Other: Post-test genetic counseling delivered by telephone

In-person post-test genetic counseling

No Intervention group

Description:

Post-test genetic counseling delivered in-person