Breast CancerQoLNCT05857670
Psyco Quality of Life and Procreation BRCA1/2
An observational study of Breast Cancer and Genetic Predisposition, run by Regina Elena Cancer Institute at 2 sites in Italy.
Trial summary
Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Genetic Predisposition
- What is being tested?
- Genetic predisposition to breast cancer
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 31 May 2022to 31 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women with BRCA1/2 mutation
Who may be able to join
- Women with BRCA1/2 mutation affected or not by breast neoplasm
- Women with BRCA1/2 mutation affected or not by breast neoplasm and with at least a son/daughter
- Women with at list middle school diploma
- Women available to do interviews
Who cannot join
- Women with other oncological pathology
- Women with cognitive deficient and/or inability to comply to the requirements of the study
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
"Regina Elena" National Cancer Institute
Rome, 00144
- Recruiting
Università dell'Insubria
Varese, 21100
Marco Bellani
About this study
Official title: Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision
Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. BRCA1/2 mutations are inherited as an autosomal dominant manner and therefore there is a 50% probability of transmitting the mutation to the progeny. For this reason, women who have BRCA 1/2 mutation may be less likely to want children than those who test negative. The decision to have children could worry both for the probability to transfer the genetic mutation or because the parenthood could be compromised by the illness and/or by premature death. In previous studies, the psychological condition of patients with BRCA 1/2 mutations, with or without children, was only partially investigated. For this reason the main goal of the study is to deeply investigate the specific psychological condition, with particular attention to the guilt feelings on the possibility to transfer the genetic mutation to the progeny. In this wai it could be useful to development a therapeutic strategies aimed at the best adaptation of the patients to the new health condition.
- Conditions
- Breast Cancer, Genetic Predisposition
- Being tested
- Genetic predisposition to breast cancer
- Medical subject headings
- Breast Neoplasms, Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic predisposition to breast cancerBehavioural
Guilt feelings about procreating
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of feeling guilting
- ISGR-15s
- Il PFQ-2
- PHQ-9
Measured: 24 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start31 May 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Regina Elena Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857670
- Sponsor's protocol ID
- RS1702/22
- Acronym
- QoL
- Status last verified
- Jan 2024
- First submitted
- 27 Mar 2023
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision
- ClinicalTrials.gov ID
- NCT05857670
- Acronym / sponsor ID
- QoL / RS1702/22
- Conditions
- Breast Cancer, Genetic Predisposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Regina Elena Cancer InstituteUniversity, hospital or other
- Study start
- 31 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 May 2023 (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.
Women with breast and/or ovarian cancer or with a family history carried these pathologies can makeo genetic counseling in order to investigate whether they are carriers of the BRCA1/2 genetic mutation. This mutation exposes them to develop breast cancer from 50 to 80% and from 27 to 65% of developing ovarian cancer. BRCA1/2 mutations are inherited as an autosomal dominant manner and therefore there is a 50% probability of transmitting the mutation to the progeny. For this reason, women who have BRCA 1/2 mutation may be less likely to want children than those who test negative. The decision to have children could worry both for the probability to transfer the genetic mutation or because the parenthood could be compromised by the illness and/or by premature death. In previous studies, the psychological condition of patients with BRCA 1/2 mutations, with or without children, was only partially investigated. For this reason the main goal of the study is to deeply investigate the specific psychological condition, with particular attention to the guilt feelings on the possibility to transfer the genetic mutation to the progeny. In this wai it could be useful to development a therapeutic strategies aimed at the best adaptation of the patients to the new health condition.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women with BRCA1/2 mutation
Key inclusion criteria (4 listed)
- Women with BRCA1/2 mutation affected or not by breast neoplasm
- Women with BRCA1/2 mutation affected or not by breast neoplasm and with at least a son/daughter
- Women with at list middle school diploma
- Women available to do interviews
Key exclusion criteria (2 listed)
- Women with other oncological pathology
- Women with cognitive deficient and/or inability to comply to the requirements of the study
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 |
|---|---|---|
| Genetic predisposition to breast cancerGuilt feelings about procreating | Behavioural | – |
Primary outcome
Evaluation of feeling guilting
Time frame: 24 monts
* ISGR-15s * Il PFQ-2 * PHQ-9
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Genetic Predisposition, run by Regina Elena Cancer Institute at 2 sites 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 4 inclusion and 2 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Anita Caruso (+39 06 52665332, anita.caruso@ifo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of feeling guilting (time frame: 24 monts). 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 1 Feb 2024.