Exploring the quality of life and family planning in women with BRCA1/2 mutations
Women With BRCA1/2 Mutation: Guilt Feelings and Impact on Procreation Decision
This study looks at how having BRCA1/2 mutations affects the quality of life and family planning decisions for women with breast or ovarian cancer or a family history of these cancers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 25 Years to 45 Years |
| Sex | Female |
| Sponsor | Regina Elena Cancer Institute Academic / other |
| Locations | 2 sites (Rome and 1 other locations) |
| Trial ID | NCT05857670 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women who are either diagnosed with breast and/or ovarian cancer or have a family history of these conditions, specifically investigating the impact of BRCA1/2 genetic mutations on their quality of life and decisions regarding procreation. Participants will undergo genetic counseling to determine their mutation status and will be interviewed to assess their psychological well-being and family planning considerations. The study aims to fill gaps in understanding how these mutations influence women's choices about having children and their mental health. By gathering qualitative data, the research seeks to provide insights into the unique challenges faced by this population.
Who should consider this trial
Good fit: Ideal candidates for this study are women with BRCA1/2 mutations, regardless of whether they have been diagnosed with breast cancer, and who have at least one child.
Not a fit: Patients with other oncological pathologies or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights that help improve psychological support and counseling for women with BRCA1/2 mutations regarding family planning.
How similar studies have performed: Previous studies have partially explored the psychological aspects of BRCA1/2 mutations, but this specific focus on quality of life and procreation decisions is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Women with other oncological pathology * Women with cognitive deficient and/or inability to comply to the requirements of the study
Where this trial is running
Rome and 1 other locations
- "Regina Elena" National Cancer Institute — Rome, Italy (Recruiting)
- Università dell'Insubria — Varese, Italy (Recruiting)
Study contacts
- Study coordinator: Anita Caruso
- Email: anita.caruso@ifo.it
- Phone: +39 06 52665332
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.