Clinical trial NCT04759352: Telephone Versus In-person Post-test Cancer Genetic Counseling
Official title: Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer Gene Mutation
Keywords: genetic telecounselling
test result communication
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 724
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: "Multidimensional Impact of Cancer Risk Assessment" questionnaire
timeFrame: Seven days after the post-test genetic counseling session
measure: "Patient perceptions of the genetic counseling questionnaire"
timeFrame: Seven days after the post-test genetic counseling session
measure: "Genetic Counselor process Questionnaire"
timeFrame: Immediately after the post-test genetic counseling session
Secondary outcomes:
measure: Influence of sociodemographic and medical history on genetic counseling outcomes
timeFrame: Data collection during pre-test genetic counseling session
measure: Impact of logistics on genetic counseling preferences
timeFrame: Data collection during the pre-test genetic counseling session
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: UO Genetica Medica, IRCCS AOU di Bologna
Study officials:
References: