Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Cervical Cancer
- Endometrial Cancer
- Gynecologic Cancer
- Vaginal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: After signed informed consent, women complete the baseline questionnaire. After completion of the baseline questionnaire and before the end of RT, patients will be randomized to either the intervention group or the control group. The control group receives care as usual. The intervention group receives the nurse-led sexual rehabilitation intervention. All patients have follow-up appointments with their radiation-oncologist (or gynecologic oncologist) at 1, 3, 6 and 12 months post RT. For the intervention group, the sexual rehabilitation intervention sessions with the nurse will be planned immediately following the appointment with the radiation-oncologist. Women in the intervention group who are treated with RTBT receive an extra session 2 months after the end of radiotherapy. All patients are asked to complete questionnaires at baseline, and 1, 3, 6, and 12 months after completion of RT.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Only males
Description
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only (i.e., RT) or external pelv...
The primary objective of this randomized controlled trial is to evaluate if the nurse-led sexual rehabilitation intervention improves sexual recovery and functioning in patients with gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only (i.e., RT) or external pelvic radiotherapy combined with brachytherapy (i.e., RTBT) compared with usual care (Q1). The secondary objective is to evaluate if the nurse-led sexual rehabilitation program decreases vaginal symptoms and body image concerns, fear of (non-)coital sexual activity, treatment-related distress, psychological and sexual distress, and vaginal physical symptoms (assessed during physical examination by the radiation oncologist), and improves/increases generic-related health related quality of life related to gynaecological cancer, relationship satisfaction, and frequency of dilator use, (Q2); to evaluate the cost-effectiveness of the intervention (Q3); and to evaluate whether an improvement in sexual functioning is moderated by treatment characteristics and pre-treatment patient characteristics, such as age or sexual functioning, and mediated by reduction of vaginal symptoms (and by regular use of dilators in women treated with RTBT) (Q4).
Tracking Information
- NCT #
- NCT03611517
- Collaborators
- Dutch Cancer Society
- Investigators
- Study Chair: Moniek M ter Kuile, PhD Leiden University Medical Center Principal Investigator: Carien L Creutzberg, MD, PhD Leiden University Medical Center Principal Investigator: Jan Willem M Mens, MD Erasmus Medical Center