In this study, we evaluate the efficacy of a sexual rehabilitation programme in improving the sexual functioning of women who are treated with radiotherapy for gynaecological cancer. The rehabilitation programme is compared to optimal regular care (…
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Brief title
Condition
- Sexual function and fertility disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is sexual functioning 12 months after radiotherapy.
Secondary outcome
The secondary outcomes include: sexual functioning 24 months after
radiotherapy, vaginal symptoms and body image concerns, fear of coital and
non-coital sexual activity, sexual distress, treatment-related distress,
generic health-related quality of life related to gynaecological cancer,
psychological distress, relationship dissatisfaction, frequency of dilator use,
and vaginal physical symptoms.
Background summary
In the Netherlands, more than 4000 women are diagnosed with gynaecological
cancers (GC) annually, of whom 30-40% receive primary or postoperative pelvic
radiotherapy (RT), often combined with brachytherapy (BT). GC treatment and RT
in particular, is associated with high rates of sexual problems, such as pain
during intercourse, and vaginal symptoms (dryness, shortening and/or
tightening). In cooperation with the relevant end-users in the Netherlands, we
developed a nurse-led sexual rehabilitation intervention directed at increasing
knowledge and coping strategies of patients (and their partners if available)
regarding sexual issues after RT and benefits of and compliance with dilator
use after RT+BT. The intervention has been pilot-tested at two university
medical centres (P13.102). Most patients reported that the intervention was
helpful in resuming their sexual relationship. The nurses reported that they
had sufficient expertise to support the participants during sexual
rehabilitation and vaginal dilator use. Based on these findings, we concluded
that this intervention was feasible and applicable in clinical practice.
Study objective
In this study, we evaluate the efficacy of a sexual rehabilitation programme in
improving the sexual functioning of women who are treated with radiotherapy for
gynaecological cancer. The rehabilitation programme is compared to optimal
regular care (i.e., oral and written information about sexual functioning after
radiotherapy for gynaecological cancer, and one-time education/information by
the radiotherapist-oncologist and/or oncology nurse).
Study design
Women with gynaecological cancer (N = 220), who are treated with radiotherapy
in one of the participating Gynaecological Cancer Centres, are randomized to
either the intervention- or control group. Stratification variables included in
the randomization are treatment (RT+BT vs. RT only women) en having a partner
(yes/no). Women in the control group receive 'optimal regular care', which
includes oral and written information about sexual problems after
gynaecological cancer and one-time education/information by the
radiotherapist-oncologist and/or oncology nurse). Women in both the
intervention- and control group complete study assessments at baseline, and 1
month, 3 , 6, 12 and 24 months after radiotherapy.
Intervention
Women in the intervention group receive information about sexual rehabilitation
after gynaecological cancer (a brochure and website) and guidance in sexual
rehabilitation from an oncology-nurse by means of four appointments (1, 3, 6
and 12 months after radiotherapy). Women who are treated with RT+BT, receive an
extra appointment with the nurse in order to provide these women with
additional support in the usage of the vaginal dilators to prevent stenosis.
This sexual rehabilitation programme aims to increase the understanding of and
compliance with the instructions to use vaginal dilators. Oncology nurses
conduct the intervention after a 50-hour training in sexology and cognitive
behavioural interventions. The oncology nurses are supervised by trained
psychologists/sexologists. The control group receives 'optimal regular care',
which consists of the same information that is given to the intervention group
and one-time education by the radiotherapist-oncologist and/or oncology nurse.
Study burden and risks
Participating in this study will not cause any (physical) harm for the
participants. Participants will be asked to fill in online questionnaires six
times (30-40 minutes per assessment).and the radiotherapist will measure the
vagina during the control visits (5x). Completion the questionnaires may cause
some discomfort because of the subject and the time investment they have to
make.
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
The study population will be composed of 220 women, who 1) are 18 years or
older, 2) will be treated with radiotherapy for gynaecological cancer and who
3) wish to retain sexual activity on the short- or long-term. The study sample
will consist of women who will be treated with RT or RT+BT for gynaecological
cancer:
• RT: Postoperative pelvic external beam radiotherapy for cancer of the cervix,
vagina or endometrium.
• RT+BT: either primary or postoperative pelvic external beam radiotherapy for
cancer of the cervix, vagina or endometrium with a brachytherapy boost by
intra-uterine and/or vaginal brachytherapy; this includes treatment with RT+BT
for local relapse after previous surgery for cervix, vaginal or endometrial
cancer.
Exclusion criteria
Women will be excluded from the study if they: 1) are living abroad during
follow-up; 2) have insufficient knowledge of the Dutch language; 3) have major
psychiatric disorders (i.e., major affective disorder, psychotic disorder,
substance abuse related disorder, or posttraumatic stress disorder resulting
from abuse in the area of the pelvic floor and genitals (e.g. sexual abuse)).
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL62767.058.17 |
| Other | NTR7175 en NCT03611517 |
| OMON | NL-OMON20908 |