By investigating reasons for (non-)compliance with vaginal dilation in a sample of gynecological cancer patients receiving RT, we hope to identify facilitating and limiting factors relevant for the development of a sexual rehabilitation program.…
ID
Source
Brief title
Condition
- Reproductive neoplasms female benign
- Sexual dysfunctions, disturbances and gender identity disorders
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Sexual functioning, Sexual distress, Experiences with vaginal dilation therapy,
Sexual rehabilitation after RT, Acceptability/Understandability of the
information booklet.
Secondary outcome
Treatment, Somatic and Psychological variables
Background summary
In the Netherlands, more than 4000 women are diagnosed with gynecological
cancers annually, and 40% will receive pelvic radiotherapy (RT) with or without
brachytherapy (BT) as primary or post-surgical treatment. Gynecological cancer
treatment, RT combined with BT in particular, have been shown to be associated
with high rates of sexual problems such as reduced sexual interest and
satisfaction, pain during intercourse and vaginal symptoms (dryness, shortening
and/or tightening). Regular use of vaginal dilators reduces the risk of vaginal
fibrosis and stenosis after RT, and has become established practice worldwide.
Despite the proposed benefits of dilation therapy, many women have difficulties
following the instructions and/or fail to use vaginal dilators regularly.
Study objective
By investigating reasons for (non-)compliance with vaginal dilation in a sample
of gynecological cancer patients receiving RT, we hope to identify facilitating
and limiting factors relevant for the development of a sexual rehabilitation
program. Another purpose of the current study is to evaluate the patient
information booklet for the sexual rehabilitation on comprehensibility,
satisfaction with information and content.
Study design
A qualitative multicenter study in women with (a history of) gynecological
cancer who received RT and BT. A maximum of 25 women with be interviewed about
reasons for (non-) compliance with vaginal dilation. Ten of these women will be
asked to also evaluate the information booklet about sexual issues and benifits
of dilator use.
Study burden and risks
Participants will be asked questions about personal themes, which may be of
some discomfort for some of the participants. The total duration of each
interview will be 60 minutes maximum. There will be no risks for the
participants.
Albinusdreef 2
Leiden 2300 RC
NL
Albinusdreef 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
Women will be invited to participate in the current study if they have been treated with primary radiation therapy between 6 and 24 months previously, were sexually active before their cancer diagnosis, and are consenting to being interviewed about vaginal dilation and sexuality. A selection of ten of these women ( who have indicated to be willing to participate in future studies)will be made to evaluate the information booklet.
Exclusion criteria
Signs of recurrent or metastatic cancer, insufficient knowledge of the Dutch language, or living abroad.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL41267.058.12 |