cancer of the cervix cervical cancer
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All eligible patients: have been treated for stage IA2-IIA cervical cancer with nerve-sparing radical hysterectomy with pelvine lymfeadenectomy and post-operative radiation therapy; therapy must be completed at least 12 months before; no singn of recurrance or metastatic disease when the patiënt is included; are capable of understanding, reading and writing the Dutch language; have performance status of WHO 1-2, Karnofsky >60 and are
Exclusion criteria
Exclusion criteria: Women in whom intravaginal brachy-therapy and/or concomitant chemotherapy has been administered are not included.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sexual response measurement To measure genital arousal, vaginal pulse amplitude (VPA) will be assessed by a vaginal photoplethysmograph. The photoplethysmograph is a menstrual tampon-sized device, containing an orange-red light source and a photocell. The light source illuminates the capillary bed of the vaginal wall and the phototransistor responds to the light backscattered by the vaginal wall and the blood circulating within it. When the signal is connected to an alternating current (AC) amplifier, vaginal pulse amplitude is measured, which reflects the phasic changes in vaginal engorgement accompanying each heartbeat, with larger amplitudes reflecting higher levels of vaginal vasocongestion. VPA is a sensitive, specific, and reliable measure of vaginal vasocongestion and is used in earlier studies that observed diminished vaginal blood flow in women with neurological damage11 and in women after radical hysterectomy4, 9. VPA will be continuously recorded during the neutral film excerpts and the erotic film excerpts. Subjective sexual arousal and genital sensations will be assessed through 3 self-report ratings that will be collected after each neutral film and after each erotic stimulus. Participants will be asked to indicate on a seven-point Likert scale their feelings of sexual arousal, their strongest feelings of sexual arousal, and their genital sensations. Extremes of the Likert scale will be 1 *not at all*, to 7 *very strong*. | — |
Secondary
| Measure | Time frame |
|---|---|
| Questionnaires Sexual-, bladder- and bowel complaints are assessed with questionnaires; respectively the Leiden Gynaecological questionnaire (see Appendix II) and the Gynaecological complaints questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC) EORTC QLQ-CX24. More over, the general and health related quality of life is assessed by the Quality of Life questionnaire of the EORTC (EORTC QLQ-C30). These questionnaires are especially designed and validated for the assessment of the quality of life and complaints of women after treatment for gynecological malignancies. | — |
Countries
Netherlands
Outcome results
None listed