Cancer Gene MutationGEO-STARNCT04759352
Telephone Versus In-person Post-test Cancer Genetic Counseling
A study testing Post-test genetic counseling delivered by telephone in people with Cancer Gene Mutation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Gene Mutation
- What is being tested?
- Post-test genetic counseling delivered by telephone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 724 participants
- Where
- 1 siteItaly
- Study dates
- 15 May 2021to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
UO Genetica Medica, IRCCS AOU di Bologna
Bologna, 40138
Lea Godino, PhD, 0512143694, lea.godino@aosp.bo.it
About this study
Official title: Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
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.
Read the 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 (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.
- Conditions
- Cancer Gene Mutation
- Being tested
- Post-test genetic counseling delivered by telephone
- Keywords
- genetic telecounselling, test result communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-test genetic counseling delivered by telephoneOther
Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.
| Study group | Role | What they receive |
|---|---|---|
| Telephone post-test genetic counseling | Experimental | Post-test genetic counseling delivered by telephone Receives: Other: Post-test genetic counseling delivered by telephone |
| In-person post-test genetic counseling | No intervention | Post-test genetic counseling delivered in-person |
What is being measured
The primary outcome is the main question the study is designed to answer.
"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.
Measured: 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.
Measured: 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.
Measured: Immediately after the post-test genetic counseling session
Secondary outcomes (2)
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.
Measured: 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
Measured: Data collection during the pre-test genetic counseling session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start15 May 2021
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Gene MutationStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 724 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Turchetti, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759352
- Sponsor's protocol ID
- GEO-STAR
- Acronym
- GEO-STAR
- Status last verified
- Jul 2021
- First submitted
- 15 Feb 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Genetic Counseling: Telephone Versus Standard In-person Delivery. A Randomized Trial (GEO-STAR)
- ClinicalTrials.gov ID
- NCT04759352
- Acronym / sponsor ID
- GEO-STAR / GEO-STAR
- Conditions
- Cancer Gene Mutation
- Keywords
- genetic telecounselling, test result communication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 724 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 15 May 2021 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone post-test genetic counseling | Experimental | Other: Post-test genetic counseling delivered by telephonePost-test genetic counseling delivered by telephone |
| In-person post-test genetic counseling | No intervention | –Post-test genetic counseling delivered in-person |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients unable to provide informed consent, for example due to mental incapacity or active psychotic illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-test genetic counseling delivered by telephoneParticipants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone. | Other | Telephone post-test genetic counseling |
Primary outcome
"Multidimensional Impact of Cancer Risk Assessment" questionnaire
Time frame: Seven days after the post-test genetic counseling session
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.
"Patient perceptions of the genetic counseling questionnaire"
Time frame: Seven days after the post-test genetic counseling session
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.
"Genetic Counselor process Questionnaire"
Time frame: Immediately after the post-test genetic counseling session
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.
2 secondary outcomes
Influence of sociodemographic and medical history on genetic counseling outcomes
Time frame: Data collection during pre-test genetic counseling session
Impact of logistics on genetic counseling preferences
Time frame: Data collection during the pre-test genetic counseling session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-test genetic counseling delivered by telephone in people with Cancer Gene Mutation, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lea Godino (0512143694 ext. +39, lea.godino@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"Multidimensional Impact of Cancer Risk Assessment" questionnaire (time frame: Seven days after the post-test genetic counseling session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.