A randomized study of an internet-based cognitive behavioral therapy program for sexuality and intimacy problems in women treated for breast cancer.

Phase 3

Recruiting

Conditions: problems with sexuality and intimacy
Sexual dysfunctions and intimacy problems
10006291
10040480

Registration Number: NL-OMON40346

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 240

Inclusion Criteria

The study sample will be composed of 160 women, between 18 and 65 years of age, with histologically confirmed breast cancer, who received treatment in one of the participating hospitals. All women will have completed treatment (with the exception of endocrine therapy), received their diagnosis between 6 months and 5 years prior to study entry, and will be disease-free at time of study entry. Potentially eligible women will be screened for the presence of sexuality and intimacy problems.

Exclusion Criteria

Women will be excluded from the study if they: lack basic proficiency in Dutch; do not have access to the internet; exhibit serious cognitive or psychiatric problems (i.e. major depression, alcohol dependency, or psychotic disorders); report severe relationship problems for which the internet-based program is not designed (and which need to be addressed prior to undergoing sex therapy); are participating in a concurrent therapy program to alleviate their sexuality/intimacy problems; or have been treated for another type of cancer besides breast cancer (with the exception of cervical carcinoma in situ and basal cell carcinoma).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary study outcomes are sexuality problems, as assessed with the Sexual<br /><br>Activity Questionnaire (SAQ), the Female Sexual Dysfunction Index (FSFI), and<br /><br>the Female Sexual Distress Scale (FSDS), and intimacy problems, as assessed<br /><br>with the PAIR Inventory. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study outcomes are body image (QLQ-BR23), menopausal symptoms<br /><br>(FACT-ES), marital functioning (MMQ), psychological distress (HADS), and health<br /><br>related quality of life (MOS SF-36). </p><br>