Cervical Cancer
Conditions
Brief summary
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle compared to those who undergo care within routine clinical practice.
Detailed description
Prospective, randomized 2:1 study in favor of the intervention group, multicenter, superiority, to be performed in patients treated for cervical cancer divided into 2 study groups: 1) intervention group that will undergo a multimodal intervention in the sexual sphere and lifestyle; and 2) control group according to routine clinical practice.
Interventions
DRUGSex hormones and modulators of the genital system.
To assess the improvement in sexual function and self-perceived quality of life using PROMs (Patient-Reported Outcomes) in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle.
Sponsors
Fundacion Clinic per a la Recerca Biomédica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women of legal age. * Patients with primary cervical cancer stage FIGO I-III (initial or locally advanced) of squamous histology, adenocarcinoma or adenosquamous. * Patients treated for cancer with surgery and/or radiotherapy ± systemic treatment in the Gynaecological Oncology Units of hospitals in Spain. * Complete response after oncospecific treatment was obtained. * Signature of the informed consent (IC) by the patient or responsible family member.
Exclusion criteria
* Patients under 18 years of age. * Pregnancy or breastfeeding. * Partial response after completion of oncospecific treatment. * Patients with premalignant pathology. * Diagnosis of a tumor of non-cervical origin or atypical histologies. * Impossibility of completing the questionnaires included in the protocol autonomously. * Contraindications to the use of vaginal estrogens. * Patients undergoing fertility-sparing treatment (trachelectomy or conization). * Patients undergoing palliative treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the improvement in sexual function and self-perceived quality of life using Patient-Reported Outcomes in patients treated for cervical cancer who undergo a multimodal intervention in the sexual sphere and lifestyle. | Month 12(V5). | Global score on the Female Sexual Function Index (FSFI) form at the end of the first year after treatment. The values go from zero to five, or from 1 to 5. A higher score mean a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate sexual function (using the Female Sexual Function Index (FSFI) questionnaire) in women treated for cervical cancer after completion of treatment and its evolution over one year. | Baseline level(V2), 3 months after treatment(V3), at 6 month(V4) and 12 months after treatment(V5). | Score on the Female Sexual Function Index (FSFI) form at diagnosis, after treatment (defined as baseline level: 1 month after surgery and 3 months after treatment with radiotherapy ± systemic treatment), at 6 and 12 months after treatment. The score in each of the sexual response domains that make up the FSFI (subjective desire and stimulus, lubrication, orgasm, satisfaction, and pain or discomfort) will also be evaluated individually. The Female Sexual Function Index values go from zero to 5 or from 1 to 5. The higher scores the better outcome. |
| To evaluate self-perceived quality of life questionnaires in women treated for cervical cancer after completing treatment and its evolution over one year. | At diagnosis(V1), after treatment(V2), at month 6(V4), and month 12(V5) after the treatment | Score on the quality of life forms at diagnosis, at baseline level(after treatment), at 6 months and 12 months after baseline level(after treatment). The score on each of the 5 functional scales (physical functioning, daily activities, emotional functioning, cognitive functioning and social functioning), 3 symptom scales (fatigue, pain and nausea, vomiting), the global health status scale and the 6 independent items (dyspnea, insomnia, anorexia, constipation, diarrhoea and economic impact) that make up the European Organisation for Research and treatment of Cancer(EORTC QLQ-30) will also be assessed individually. The first 28 questions got values which go from 1 to 4 and the lower score the better outcome. The other two last ones have values go from 1 to 7 and the higher scores the better outcome. |
| To detect the needs of the treated patients based on the Patient-Reported Outcome Measures(PROMs) questionnaires, that allow proposing improvement strategies that can increase their sexual health and quality of life. | Month 12(V5) | Adherence to multimodal treatment in the intervention arm, defined as the percentage of patients in the intervention arm who have undergone each of the items included in the multimodal treatment. The items included in the multimodal treatment are the use of moisturizing creams vaginal and vulvar without hormones and topical vaginal estrogens with their dosage, the use of the personal massager staff, and access to the informative content about life habits. |
| To evaluate vaginal trophism more objectively using the Vaginal Health Index (VHI) in women with cervical cancer after completion of treatment and over the course of one year. | Through study completion, an average of one year | Number of adverse effects related with the use of treatments, assessing their number, severity and type (A - Augmented; B - Bizarre) |
| To evaluate adherence to the proposed multimodal treatment and the adverse effects reported. | At Baseline level(V2), at month 6(V4) and month 12(V5) | Vaginal Health Index (VHI) score for assessment of vaginal trophism at diagnosis, baseline level(after treatment), at 6 and 12 months after baseline level. |
| To evaluate vaginal trophism more objectively using the vaginal thickness measured by ultrasound in women with cervical cancer after completion of treatment and over the course of one year. | Throught study completion, an average of one year | Number of adverse events related to the use of treatments, assessing their number, severity and type(A-Augmented; B-Bizarre) |
Countries
Spain
Contacts
CONTACTLaura B Burunat, Graduate
Outcome results
None listed