Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04759352
Status:
RECRUITING
Last Update Posted:
2021-07-28
First Post:
2021-02-15
Brief Title:
Telephone Versus In-person Post-test Cancer Genetic Counseling
Sponsor:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Organization:
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Study Overview
Official Title:
Cancer Genetic Counseling Telephone Versus Standard In-person Delivery A Randomized Trial GEO-STAR
Status:
RECRUITING
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEO-STAR
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 httpwwwserviziregioneemilia-romagnaitgeneratore
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None