Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Number of patients using currently CHCs
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 52 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Number of patients using currently CHCs
Time Frame: Through study completion, an average of 1 month
Evaluation of the number (%) of patients using currently CHCs
Perception about the impact of CHCs on favoring/contrasting specific cancer onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific chronic disease onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Perception about the impact of CHCs on favoring/contrasting specific symptoms onset
Time Frame: Through study completion, an average of 1 month
By using a Likert scale (from -5 to +5)
Number of patients having used CHCs
Time Frame: Through study completion, an average of 1 month
Evaluation of the number (%) of patients having used CHCs in the past
Secondary Outcomes
No secondary outcomes reported
Investigators
Simone Ferrero
principal investigator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia