A nurse-led sexual rehabilitation programme for women with gynaecological cancers receiving radiotherapy: a randomized multicentre trial.

Recruiting

• Conditions: sexual complaints; sexual problems; 10013356

• Registration Number: NL-OMON55440
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 220

Inclusion Criteria

The study population will be composed of 220 women, who 1) are 18 years or
older, 2) will be treated with radiotherapy for gynaecological cancer and who
3) wish to retain sexual activity on the short- or long-term. The study sample
will consist of women who will be treated with RT or RT+BT for gynaecological
cancer:
• RT: Postoperative pelvic external beam radiotherapy for cancer of the cervix,
vagina or endometrium.
• RT+BT: either primary or postoperative pelvic external beam radiotherapy for
cancer of the cervix, vagina or endometrium with a brachytherapy boost by
intra-uterine and/or vaginal brachytherapy; this includes treatment with RT+BT
for local relapse after previous surgery for cervix, vaginal or endometrial
cancer.

Exclusion Criteria

Women will be excluded from the study if they: 1) are living abroad during
follow-up; 2) have insufficient knowledge of the Dutch language; 3) have major
psychiatric disorders (i.e., major affective disorder, psychotic disorder,
substance abuse related disorder, or posttraumatic stress disorder resulting
from abuse in the area of the pelvic floor and genitals (e.g. sexual abuse)).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome is sexual functioning 12 months after radiotherapy.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes include: sexual functioning 24 months after<br /><br>radiotherapy, vaginal symptoms and body image concerns, fear of coital and<br /><br>non-coital sexual activity, sexual distress, treatment-related distress,<br /><br>generic health-related quality of life related to gynaecological cancer,<br /><br>psychological distress, relationship dissatisfaction, frequency of dilator use,<br /><br>and vaginal physical symptoms.</p><br>