Clinical trial · Observational
Sexual Function, Coping and Dyadic Coping in Patients With Cervical Cancer
Sexual Function, Coping and Dyadic Coping in Cervical Cancer Patients: a Comparison Between Surgery and Radiotherapy Plus Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| psychological assessment evaluation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Radio-chemotherapy
- description
- Cervical cancer patients undergoing radio-chemotherapy.
- interventionNames
- Behavioral: psychological assessment evaluation
- label
- Surgery
- description
- Cervical cancer patients undergoing surgery.
- interventionNames
- Behavioral: psychological assessment evaluation
Primary outcomes (2)
- 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.
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available