Sexual Function, Coping and Dyadic Coping in Patients With Cervical Cancer

NCT ID: NCT06124040

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 154 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-23
• Study Completion Date: 2024-10-31

Brief Summary

The studies currently available in the literature about sexual function and coping in cervical cancer are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. Moreover, a baseline evaluation about sexual function and coping if often lacking.

Aim of this protocol is to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:

• To assess sexual function, coping, emotional distress, and quality of life of patients with cervical cancer undergoing surgery vs radiotherapy plus chemotherapy.
• To evaluate changes on the previous variables over 6 months.

The results obtained will be utilized for:

• planning precocious psycho-educational interventions aimed at promoting psychological and couple well-being in cervical cancer patients since diagnosis
• develop tools and educational programs for more appropriate communication about intimacy between healthcare professionals and patients.

Detailed Description

Many recent reviews focused on QoL and the sexual function of patients with cervical cancer and have only evaluated the sexual dysfunctions of patients undergoing chemo-radiotherapy plus interventional radiotherapy.

The studies currently available in the literature are poor and heterogeneous, and their results are often conflicting; therefore, no definitive recommendations can be formulated. Furthermore, it is unclear whether the dysfunction is attributable to surgical sequelae, radiotherapy, chemotherapy, or psychological aspects related to cancer. In fact, psychological factors caused by the cancer diagnosismay also negatively influence sexual functioning independently of the type of treatment or stage of cancer.

Common psychological issues included poor body image, decreased sense of femininity, anxiety about sexual interactions, and pain.

Consequently, related social issues may emerge, for example, the ability to maintain a sexual relationship, communication difficulties, and adverse effects on intimate relationships.

Women with cervical cancer have thus independently significant issues related to sexual functioning as a result of their disease and/or its treatment. The most important classification for cervical cancer is FIGO (International Federation Gynecology and Obstetrics) updated in 2021. Treatments for cervical cancer are different depending on this classification. Although early-stage cervical cancers have different prognosis and treatments with respect to invasive cervical cancers (surgery vs chemoradiation plus interventional radiotherapy), both types can have a major impact on patients' sexual function and coping, also dyadic coping since diagnosis.

For this reason, we decided to perform a prospective longitudinal study to compare surgical vs. radio-chemotherapy cervical cancer patients, with the following objectives:

Primary objectives: to assess sexual function and coping Secondary objective: to evaluate emotional distress; dyadic coping; anxiety and depression; QoL of patients with cervical cancer; association between coping and possible dissociative symptoms; changes on the previous variables over 6 months.

Conditions

Uterine Cervical Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Radio-chemotherapy

Cervical cancer patients undergoing radio-chemotherapy.

psychological assessment evaluation

Intervention Type: BEHAVIORAL

A prospective data collection will be performed with self-administered psychological measures, with the aim to compare two different groups of patients with cervical cancer neo diagnosis, candidates for non conservative surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines.

Test will be repeated at Time 0 (firs access in radiotherapy Day Hospital, or first access in hospital ward for surgery), and Time 1 (after 6 months).

Surgery

Cervical cancer patients undergoing surgery.

psychological assessment evaluation

Intervention Type: BEHAVIORAL

A prospective data collection will be performed with self-administered psychological measures, with the aim to compare two different groups of patients with cervical cancer neo diagnosis, candidates for non conservative surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines.

Test will be repeated at Time 0 (firs access in radiotherapy Day Hospital, or first access in hospital ward for surgery), and Time 1 (after 6 months).

Interventions

psychological assessment evaluation

A prospective data collection will be performed with self-administered psychological measures, with the aim to compare two different groups of patients with cervical cancer neo diagnosis, candidates for non conservative surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines.

Test will be repeated at Time 0 (firs access in radiotherapy Day Hospital, or first access in hospital ward for surgery), and Time 1 (after 6 months).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients' age ≥ 18 years
• Patients undergoing non-conservative surgery or radiotherapy plus chemotherapy
• Patients able to understand and sign informed consent

Exclusion Criteria

• Patients' age > 65 years
• Patients with inability to express informed consent
• Patients denying informed consent
• Patients with psychopathological disturbances preexisting to the cancer diagnosis
• Patients affected by severe language deficits

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Letizia Lafuenti

Role: primary

letizia.lafuenti1@policlinicogemelli.it

00390630156280

Other Identifiers

6044

Identifier Type: -

Identifier Source: org_study_id