Clinical trial NCT06124040: Sexual Function, Coping and Dyadic Coping in Patients With Cervical Cancer
Official title: Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-11-09
Enrollment: 154
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with cervical cancer neo diagnosis, pertaining to the Gynecologic Oncology and Radiotherapy Oncology Units of Fondazione Policlinico Universitario A. Gemelli IRCCS, candidates for surgery or radio-chemotherapy treatment, based on FIGO Gynecologic Oncology Committee Guidelines.

Based on the evidence in literature and the historical of our Institution (throughout the year 2022: 81 radiotherapy plus chemotherapy, 64 surgery), assuming a slightly lower mean difference in psychological tests scores between the two groups due to the recent improvement in irradiation techniques since the previous publication, we calculated the final sample size is 154 patients, 88 undergoing radiotherapy plus chemotherapy and 66 undergoing surgery.

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.

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

Primary outcomes:
measure: Assess sexual function in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
measure: Assess individual coping strategies in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Secondary outcomes:
measure: Evaluate dyadic coping in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
measure: Evaluate emotional Distress in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
measure: Evaluate Anxiety and Depression in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
measure: Evaluate the presence of any dissociative symtoms in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
measure: Evaluate quality of life dimensions in cervical cancer patients
timeFrame: 6 months. Time 0: the day of the beginning of the treatment (surgery or radio-chemotherapy), and Time 1: 6 months from the first assessment.
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli IRCCS
state: RM
Study officials:
References: