Telephone Versus In-person Post-test Cancer Genetic Counseling

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer Gene Mutation

Intervention / Treatment
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* Other: Post-test genetic counseling delivered by telephone


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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genetic telecounselling, test result communication