Telephone Versus In-person Post-test Cancer Genetic Counseling

NCT ID: NCT04759352

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 724 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2025-04-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telephone post-test genetic counseling

Post-test genetic counseling delivered by telephone

Group Type: EXPERIMENTAL

Post-test genetic counseling delivered by telephone

Intervention Type: OTHER

Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.

In-person post-test genetic counseling

Post-test genetic counseling delivered in-person

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Post-test genetic counseling delivered by telephone

Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Daniela Turchetti

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

UO Genetica Medica, IRCCS AOU di Bologna

Bologna, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Lea Godino

Role: CONTACT

lea.godino@aosp.bo.it

0512143694 ext. +39

Facility Contacts

Lea Godino, PhD

Role: primary

lea.godino@aosp.bo.it

0512143694

Other Identifiers

GEO-STAR

Identifier Type: -

Identifier Source: org_study_id