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

NCT05909410 | Unknown

• 1 other identifier: HORMONES-LYNCH
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Lynch Syndrome; Contraception

Keywords

Lynch syndrome

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (2)

Patients with Lynch syndrome

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

Healthy patients of reproductive age

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

Interventions

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

Healthy patients of reproductive age; Patients with Lynch syndrome

Eligibility Criteria

• Age: 18 Years - 52 Years
• Gender Eligibility Details: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia: lead

Study Sites (1)

IRCCS Ospedale Policlinico San Martino

Genova, 16132, Italy

Location

Related Publications (3)

• 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.

  PMID: 35946412 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.

  PMID: 34002428 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.

  PMID: 34124968 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Neoplastic Syndromes, Hereditary; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Simone Ferrero

  Piazza della Vittoria 14

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Ferrero, MD

CONTACT

01139 010 511525; simoneferrero@me.com

Fabio Barra

CONTACT

0039 3349437959; fabio.barra@icloud.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 18, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2023
• Study Completion: September 1, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Locations

IT (1)