Clinical trial · Interventional
Telephone Versus In-person Post-test Cancer Genetic Counseling
Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
NCT04759352CI-TRIAL-00052929GEO-STARunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Gene Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Post-test genetic counseling delivered by telephone | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Telephone post-test genetic counseling
- description
- Post-test genetic counseling delivered by telephone
- interventionNames
- Other: Post-test genetic counseling delivered by telephone
- type
- NO_INTERVENTION
- label
- In-person post-test genetic counseling
- description
- Post-test genetic counseling delivered in-person
Primary outcomes (3)
- measure
- "Multidimensional Impact of Cancer Risk Assessment" questionnaire
- timeFrame
- Seven days after the post-test genetic counseling session
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.