SPARC study; sexual rehabilitation after radiotherapy for gynaecological cancers

Recruiting

• Conditions: gynaecological; cancer; carcinoma; gynaecologische; kanker; carcinoom; cervical; cervix; baarmoederhals; vagina

• Registration Number: NL-OMON20908
• Lead Sponsor: eiden University Medical Center (LUMC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

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

Inclusion Criteria

Women (1) who will be treated with radiotherapy (2); external beam radiotherapy (RT) or external beam radiotherapy with a brachytherapy boost (RTBT) for cancer of the cervix, vagina, or endometrium (3). Women have to be 18 years or older (4) and wish to retain sexual active on the short or long term (5).

Exclusion Criteria

Living abroad during follow-up (1), major affective disorder (2), psychotic disorder (3), substance abuse related disorder (4), posttraumatic stress disorder resulting from abuse in the area of the pelvic floor and genitals (5), and insufficient knowledge of the Dutch language (6).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is sexual functioning and will be assessed with the 19-item Female Sexual Function Index (FSFI). <br /><br>We expect that the intervention condition will have a significantly higher score on the FSFI at 12 months post RT(BT), with a medium effect size (Cohen’s d=0.5), This corresponds with a difference of 3.2 points on the FSFI total score, with a standard deviation of 6.4.