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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05909410
• Other study ID #: HORMONES-LYNCH
• Status: Not yet recruiting
• Start date: July 1, 2023
• Est. completion date: September 1, 2023

Study information

• Verified date: June 2023
• Source: Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia
• Contact: Simone Ferrero, MD
• Phone: 01139 010 511525
• Email: simoneferrero[@]me.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 52 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Neoplasms, Hereditary Nonpolyposis
• Contraception
• Lynch Syndrome
• Syndrome

Intervention

Other:
• Survey investigating the CHC use and patients' perception about the relationship between CHC and cancer, diseases and symptoms
This survey investigated the CHC use (type and timing of administration) and patients' perception about the relationship between CHC and cancer, diseases and symptoms

Locations

Country	Name	City	State
Italy	IRCCS Ospedale Policlinico San Martino	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Piazza della Vittoria 14 Studio Medico - Ginecologia e Ostetricia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients using currently CHCs	Evaluation of the number (%) of patients using currently CHCs	Through study completion, an average of 1 month
Primary	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
Primary	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
Primary	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
Primary	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