Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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Perception About Benefits and Risks Related to Combined Hormonal Contraceptives Use in Patients With Lynch Syndrome

Conditions
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Lynch Syndrome, Contraception

Intervention / Treatment
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* Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 52 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with Lynch syndrome<br>Certain genetic diagnosis o fLynch syndrome | Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms<br>* This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms<br>|
| Healthy patients of reproductive age<br> | Other: Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms<br>* This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lynch syndrome