Cancer Gene Mutation Clinical Trial
— GEO-STAROfficial title:
Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
NCT number | NCT04759352 |
Other study ID # | GEO-STAR |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2021 |
Est. completion date | April 30, 2025 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Italy | UO Genetica Medica, IRCCS AOU di Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
Italy,
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 |
Status | Clinical Trial | Phase | |
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Recruiting |
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