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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer Gene Mutation
• Intervention / Treatment: Other: Post-test genetic counseling delivered by telephone

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.

• Study Type: Interventional
• Enrollment (Anticipated): 724
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lea Godino; Phone Number: +39 0512143694; Email: lea.godino@aosp.bo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • UO Genetica Medica, IRCCS AOU di Bologna
    • Contact: Lea Godino, PhD; Phone Number: 0512143694; Email: lea.godino@aosp.bo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telephone post-test genetic counseling; Post-test genetic counseling delivered by telephone	Other: Post-test genetic counseling delivered by telephone; Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.
No Intervention: In-person post-test genetic counseling; Post-test genetic counseling delivered in-person

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
"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
"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
"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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Anticipated): April 30, 2025
• Study Completion (Anticipated): April 30, 2025

Study Registration Dates

• First Submitted: February 15, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 22, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: genetic telecounselling; test result communication
• Other Study ID Numbers: GEO-STAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No