To investigate whether a short CBT intervention for sexual rehabilitation is feasible for patients (and their partners) and professionals. The available literature underscores the importance of sexual problems after pelvic RT and the need to develop…
ID
Source
Brief title
Condition
- Reproductive neoplasms female malignant and unspecified
- Sexual dysfunctions, disturbances and gender identity disorders
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frequency of dilator use, sexual functioning, sexual distress.
Atrophy, dryness, fibrosis, stenosis and vaginal shortening.
Feasability of vaginal dilation intervention.
Secondary outcome
Fears of sexuality and cancer, vaginal symptoms and self-image, anxiety,
relationship dissatisfaction
Background summary
Gynaecological cancer treatment, radiotherapy (RT) combined with brachytherapy
(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 maintain using vaginal dilators regularly. We
developed a short sexual rehabilitation intervention, based on cognitive
behavioral therapy (CBT), directed at increasing understanding of both patient
(and partner) regarding sexual issues after cancer therapy and benefits of
compliance with dilator use.
Study objective
To investigate whether a short CBT intervention for sexual rehabilitation is
feasible for patients (and their partners) and professionals.
The available literature underscores the importance of sexual problems after
pelvic RT and the need to develop strategies aimed to improve sexual
functioning, and thus quality of life, of cancer survivors. As vaginal dilation
is an essential component of sexual rehabilitation after pelvic RT, we will
focus on acceptance of and compliance with dilator use.
Study design
A prospective uncontrolled multicenter pilot-test of CBT intervention in a
sample of at least 1215 patients (and partnersat least 1with a partner, and 2-5
subjects without partner 0 partners) who received pelvic RT for gynaecological
cancer. The CBT intervention consists of four sessions of 1 hour, spread over a
period of 6 months and one follow-up last session of 30 minutes at 12 months.
This pilot study is done using (i) standardized questionnaires on sexual
functioning, sexual distress, vaginal symptoms and dilator use, and (ii)
standardized physical examination assessing the grade of mucosal changes
(atrophy, dryness), fibrosis, signs of vaginal shortening and/or stenosis.
Assessment with questionnaires and physical examination will take place before
RT (questionnaires on paper) and (online questionnaires) at 1-, 3-, 6, 12, 18
and 24 months follow-up. Filling in the questionnaires at 1, 6, 12 and 24
months after treatment will take 30 to 40 minutes, and before treatment and at
2, 3, 4 and 5 months after treatment 10 minutes maximum. (iii) Semi-structured
interviews among the couples and oncology nurses about the overall CBT
intervention feasibility will be done at 6 months. Possible partners' presence
during the CBT intervention and interview is optional and the patient decides
about this. The physical examination will be executed by the patients* own
radiation oncologists. The self-report questionnaires and interviews will be
delivered by two research assistants (not involved in the CBT treatment). Data
will be collected at two university hospitals.
Study burden and risks
Participants get five CBT sessions with material of 30-60 minutes (with
possible partner), will have to fill in questionnaires four times (30-40
minutes) and four times four questions (10 minutes maximum), will be
interviewed once (30-60 minutes) and will be examined physically during
follow-up appointments with their radiotherapist. Partners will be asked to
join the CBT sessions and interview, but this is optional. This time investment
can be experienced as a burden and participants will be asked about an intimate
subject (sexuality and dilation therapy). Participants do not however be in any
risk en will be helped with their sexual rehabilitation after radiotherapy.
Postbus 9600 2
Leiden 2300 RC
NL
Postbus 9600 2
Leiden 2300 RC
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study women have to be treated with external beam radiotherapy and brachytherapy for gynaecological cancer at Leiden University Medical Center (LUMC) or Erasmus Medical Center, Rotterdam (EMC), completing their treatment between September 2013 and March 2014. Patients have to be older than 20 years old. Patients with partner must have participated in a sexual relationship for at least 3 months and be sexually active before treatment. We expect that sexual functioning and distress will be affected by the patient*s age. In the scope of this study it will not be attainable to include two homogenous samples of two age groups (20-50 and > 50).
Exclusion criteria
A potential participant who meets any of the following criteria will be excluded from participation in this study: insufficient knowledge of the Dutch language or living abroad. In order to offer patients with psychiatric disorders comparable treatment, they will be referred to a senior psychologist or sexologist working at the patient*s own university hospital (at least one available in each centre). Patients* own radiation oncologists will screen potential subjects on the exclusion criteria during the time of diagnosis.
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL44759.058.13 |