Telephone Versus In-person Post-test Cancer Genetic Counseling

NCT04759352 | Unknown

• 1 other identifier: GEO-STAR
• Study Type: interventional
• Target: 724
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Gene Mutation

Keywords

genetic telecounselling; test result communication

Outcome Measures

Primary Outcomes (3)

• "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 Outcomes (2)

• Influence of sociodemographic and medical history on genetic counseling outcomes

  Data collection during pre-test genetic counseling session

• Impact of logistics on genetic counseling preferences

  Data collection during the pre-test genetic counseling session

Study Arms (2)

Telephone post-test genetic counseling

EXPERIMENTAL

Post-test genetic counseling delivered by telephone

Other: Post-test genetic counseling delivered by telephone

In-person post-test genetic counseling

NO INTERVENTION

Post-test genetic counseling delivered in-person

Interventions

Post-test genetic counseling delivered by telephone OTHER

Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.

Telephone post-test genetic counseling

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

UO Genetica Medica, IRCCS AOU di Bologna

Bologna, 40138, Italy

RECRUITING

Central Study Contacts

Lea Godino

CONTACT

0512143694; lea.godino@aosp.bo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: May 15, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)