Clinical trial NCT05909410: Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
Official title: Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lynch Syndrome
Contraception
Keywords: Lynch syndrome
Lead sponsor: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with certain genetic diagnosis of Lynch syndrome and of reproductive age undergoing routinely gynecological visit

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* patients with certain genetic diagnosis of Lynch syndrome and patients of reproductive age undergoing routinely gynecological visit

Exclusion Criteria:

* for both groups, a prior history of oncological diseases and a personal history of endometrial cancer, colorectal cancer, ovarian cancer, or breast cancer.
* for patients with Lynch syndrome, individuals who had undergone previous risk-reducing prophylactic surgical approaches such as (risk-reducing) colectomy, hysterectomy, early salpingectomy, and delayed oophorectomy, and risk-reducing salpingo-oophorectomy

Primary outcomes:
measure: Number of patients using currently CHCs
timeFrame: Through study completion, an average of 1 month
measure: Number of patients having used CHCs
timeFrame: Through study completion, an average of 1 month
measure: Perception about the impact of CHCs on favoring/contrasting specific cancer onset
timeFrame: Through study completion, an average of 1 month
measure: Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset
timeFrame: Through study completion, an average of 1 month
measure: Perception about the impact of CHCs on favoring/contrasting specific symptoms onset
timeFrame: Through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
Study officials:
affiliation: Piazza della Vittoria 14
name: Simone Ferrero
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.