Skip to content

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

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40346
Enrollment
240
Registered
2013-07-09
Start date
2013-10-30
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

problems with sexuality and intimacy Sexual dysfunctions and intimacy problems

Interventions

The intervention consists of an internet-based cognitive behavioral therapy program with a maximum duration of 20 weeks. Women will be motivated by the sexologist to involve their partner in the tre
discuss intimacy with partner, sensate focus) and reporting back to the therapist and receiving feedback on homework assignments. The purpose of the internet-based therapy is to provide women with

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
The primary study outcomes are sexuality problems, as assessed with the Sexual Activity Questionnaire (SAQ), the Female Sexual Dysfunction Index (FSFI), and the Female Sexual Distress Scale (FSDS), and intimacy problems, as assessed with the PAIR Inventory.

Secondary

MeasureTime frame
The secondary study outcomes are body image (QLQ-BR23), menopausal symptoms (FACT-ES), marital functioning (MMQ), psychological distress (HADS), and health related quality of life (MOS SF-36).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)