Title of study: A nurse-led sexual rehabilitation programme for women with gynaecological cancers receiving radiotherapy: a randomized multicentre trial
Version Number Approval Date: 3, 9 August 2018
Principle Investigator: M.M. ter Kuile, PhD, clinical psychologist, associate professor, Department of Gynaecology, Leiden University Medical Center
Investigator Maastro: Dr L. Lutgens
Sponsor: KWF/Alpe d'HuZes
ClinicalTrials.gov:

ClinicalTrials.gov/NCT03611517

Objectives:

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)

The primary outcome measure is sexual functioning

• Vaginal symptoms and body image concerns
• Fear of coital and non-coital sexual activity
• Level of sexual distress
• Treatment related distress
• Generic health-related quality of life related to gynaecological cancer
• Psychological distress
• Relationship dissatisfaction
• Frequency of dilator use
• Vaginal symptoms
• Cost-effectiveness
• Treatment credibility and expectancy for improvement