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Combined hormonal contraceptives (CHCs), according to the opinion by The Manchester International Consensus Group, should be considered for women wishing contraception because also positively impact endometrial cancer and ovarian cancer risk. The awareness of the effects of hormonal therapies in women at high risk of developing endometrial cancer, colorectal, breast, or ovarian cancer, such as those affected by Lynch syndrome (LS), is currently limited, with few published studies addressing these populations. Making informed decisions about CHC use in this context necessitates careful consideration of individual cancer risk and the potential benefits and risks associated with CHC use. Accurate information regarding the oncological risks associated with CHC use is essential for facilitating shared decision-making between women and their healthcare providers in this patient population.
This prospective study aims to evaluate the knowledge, attitudes, and beliefs of women with LS concerning CHCs and their potential effects on specific disease development and cancer risk, comparing them to the general population. By considering psychosocial factors and individual perceptions of cancer risk, this study seeks to contribute to informed decision-making, personalized counseling, and improved strategies for gynecologic cancer risk management in women with LS.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Lynch syndrome | Certain genetic diagnosis o fLynch syndrome |
| |
| Healthy patients of reproductive age |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms | Other | This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients using currently CHCs | Evaluation of the number (%) of patients using currently CHCs | Through study completion, an average of 1 month |
| Number of patients having used CHCs | Evaluation of the number (%) of patients having used CHCs in the past | Through study completion, an average of 1 month |
| Perception about the impact of CHCs on favoring/contrasting specific cancer onset | By using a Likert scale (from -5 to +5) | Through study completion, an average of 1 month |
| Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset | By using a Likert scale (from -5 to +5) | Through study completion, an average of 1 month |
| Perception about the impact of CHCs on favoring/contrasting specific symptoms onset | By using a Likert scale (from -5 to +5) | Through study completion, an average of 1 month |
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Inclusion Criteria:
Exclusion Criteria:
female
Patients with certain genetic diagnosis of Lynch syndrome and of reproductive age undergoing routinely gynecological visit
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Simone Ferrero, MD | Contact | 01139 010 511525 | simoneferrero@me.com | |
| Fabio Barra | Contact | 0039 3349437959 | fabio.barra@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Simone Ferrero | Piazza della Vittoria 14 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Ospedale Policlinico San Martino | Genova | 16132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35946412 | Background | Grandi G, Monari F, Boggio Sola V, Cortesi L, Toss A, Del Savio MC, Melotti C, Centurioni MG, Gustavino C, Varesco L, Facchinetti F, Barra F. BRCA mutation carriers' perception about benefits and risks associated with combined hormonal contraceptives use. Eur J Contracept Reprod Health Care. 2022 Dec;27(6):439-444. doi: 10.1080/13625187.2022.2107199. Epub 2022 Aug 10. | |
| 34002428 |
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|
| Background |
| Grandi G, Boggio Sola V, Cortesi L, Toss A, Giuliani GA, Del Savio MC, Facchinetti F. BRCA mutation carriers' perceptions on postmenopausal hormone therapy: An Italian study. Psychooncology. 2021 Oct;30(10):1711-1719. doi: 10.1002/pon.5714. Epub 2021 May 28. |
| 34124968 | Background | Grandi G, Del Savio MC, Boggio Sola V, Monari F, Melotti C, Facchinetti F. Attitudes of women towards products containing hormones (hormonal contraceptives or hormone therapy): what changes from pre to postmenopause? Ann Med. 2021 Dec;53(1):908-915. doi: 10.1080/07853890.2021.1938662. |
| 38920120 | Derived | Barra F, Perrone U, Ferrero S, Bogliolo S, Ottonello S, Gustavino C, Iasci A, Grandi G, Pulliero A, Centurioni MG, Izzotti A. Perception about benefits and risks related to combined hormonal contraceptives use in women with Lynch syndrome. Ann Med. 2024 Dec;56(1):2370568. doi: 10.1080/07853890.2024.2370568. Epub 2024 Jun 26. |
| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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