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

NCT06124040 | Unknown

• 1 other identifier: 6044
• Study Type: observational
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (2)

• Assess sexual function in cervical cancer patients

  Primary outcome is to assess sexual function of cervical cancer patients undergoing surgery vs patients undergoing radiotherapy plus chemotherapy. This dimension will be assessed by "Female Sexual Function Index" (FSFI), a survey measuring the sexual functioning of women in six different domains: desire, arousal, lubrication, orgasm, satisfaction and pain. The index only measures sexual function in these domains over the previous 30 days. The FSFI can be used as a screening tool and as a potential diagnostic aid. A total cut-off score ≤ 26.55 has been proposed for the diagnosis of female sexual dysfunction, so any woman scoring below 26.55 should be considered at risk for sexual dysfunction.

  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.

• Assess individual coping strategies in cervical cancer patients

  Assessment of individual coping strategies will be done in both groups by The Mini-Mental Adjustment to Cancer (Mini-MAC), a 29-item instrument that evaluates cognitive and behavioral responses to cancer. The factors of the Mini-MAC are: Fighting Spirit, Hopelessness, Anxious Preoccupation, Fatalism, and Cognitive Avoidance. Each item is rated on a 4-point scale that ranges from "definitely does not apply to me" to "definitely applies to me". Each statement is rated on a scale from 1 (definitely not) to 4 (definitely yes), and the available scores for each of the four coping strategies range from 7 to 28 points. The higher the score, the greater the coping/behavior style in the patient's fight against cancer.

  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 (5)

• Evaluate dyadic coping in cervical cancer patients

  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.

• Evaluate emotional Distress in cervical cancer patients

  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.

• Evaluate Anxiety and Depression in cervical cancer patients

  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.

• Evaluate the presence of any dissociative symtoms in cervical cancer patients

  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.

• Evaluate quality of life dimensions in cervical cancer patients

  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.

Study Arms (2)

Radio-chemotherapy

Cervical cancer patients undergoing radio-chemotherapy.

Behavioral: psychological assessment evaluation

Surgery

Cervical cancer patients undergoing surgery.

Behavioral: psychological assessment evaluation

Interventions

psychological assessment evaluation 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).

Radio-chemotherapy; Surgery

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli IRCCS

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: November 9, 2023
• Study Start: November 23, 2023
• Primary Completion: May 31, 2024
• Study Completion: October 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2023-10

Locations

IT (1)