Telephone Versus In-person Post-test Cancer Genetic Counseling

Cancer Gene Mutation Clinical Trial

— GEO-STAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759352
• Other study ID #: GEO-STAR
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: April 30, 2025

Study information

• Verified date: July 2021
• Source: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Contact: Lea Godino
• Phone: 0512143694
• Email: lea.godino[@]aosp.bo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 724
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer Gene Mutation

Intervention

Other:
• Post-test genetic counseling delivered by telephone
Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.

Locations

Country	Name	City	State
Italy	UO Genetica Medica, IRCCS AOU di Bologna	Bologna

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS Azienda Ospedaliero-Universitaria di Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Multidimensional Impact of Cancer Risk Assessment" questionnaire	Impact of post-test counseling on patients. The "Multidimensional Impact of Cancer Risk Assessment" questionnaire measures distress, uncertainty and positive experiences associated to cancer genetic testing. A version adapted to the Italian context will be used, where a single item related to insurance has been removed because not applicable to the Italian Health System. The resulting possible scores range from 0 to 100. Higher scores indicate more negative impacts of cancer risk assessment.	Seven days after the post-test genetic counseling session
Primary	"Patient perceptions of the genetic counseling questionnaire"	Impact of post-test counseling on patients. The range of scores is from 8 to 31. Higher scores indicate positive perception of the genetic counseling session.	Seven days after the post-test genetic counseling session
Primary	"Genetic Counselor process Questionnaire"	Professionals perceptions measured by the Genetic Counselor process Questionnaire completed by professionals who provided the post-test genetic counseling. The range of scores is from 4 to 20. Higher scores indicate positive perception of the genetic counselor.	Immediately after the post-test genetic counseling session
Secondary	Influence of sociodemographic and medical history on genetic counseling outcomes	Sociodemographic variables and family and personal cancer history will be collected during the pre-test session.	Data collection during pre-test genetic counseling session
Secondary	Impact of logistics on genetic counseling preferences	Distance (in kilometers) of patient's primary residence to the clinic location collected by the demographic data collected at pre-test genetic counseling	Data collection during the pre-test genetic counseling session