Cervical Cancer Clinical Trial
Official title:
SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
The aim of this randomized controlled trial is to demonstrate that a nurse-led sexual
rehabilitation intervention significantly improves sexual recovery and functioning among
gynaecological cancer (GC) patients treated with radiotherapy (RT), compared with usual care
(i.e., oral information by a nurse or doctor and written information).
Women with GC (n=220) who receive RT in one of the participating Dutch GC centres (n=9) will
be randomized to either the sexual rehabilitation intervention (n= 110) or usual care (n=
110), stratified for combined RTBT vs. RT alone, and for having a partner (yes/no). Women are
eligible for participation if they: have been diagnosed with either cervical, endometrial, or
vaginal cancer; are treated with radiotherapy; are 18 years or older; and wish to retain
their sexual activity on the short or long term.
The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT.
Women who received RTBT will receive an additional appointment with the nurse (2 months after
RTBT) to promote regular use of vaginal dilators in order to prevent stenosis. Participants
are requested to complete questionnaires at baseline and at 1, 3, 6, and 12 months post-RT.
The primary endpoint is sexual functioning at 12 months. Secondary endpoints include vaginal
symptoms and body concerns, fear of coital and non-coital sexual activity, sexual distress,
treatment-related distress, generic health-related quality of life, psychological distress,
and relationship dissatisfaction.
Hypothesis: The investigators expect women who receive the nurse-led sexual rehabilitation
programme to report a greater improvement in sexual functioning from immediate
post-radiotherapy to 1 year post-radiotherapy than women in the control group.
The primary objective of this randomized controlled trial is to evaluate if the nurse-led
sexual rehabilitation intervention improves sexual recovery and functioning in patients with
gynaecological cancers (GC) who are treated with either external pelvic radiotherapy only
(i.e., RT) or external pelvic radiotherapy combined with brachytherapy (i.e., RTBT) compared
with usual care (Q1).
The secondary objective is to evaluate if the nurse-led sexual rehabilitation program
decreases vaginal symptoms and body image concerns, fear of (non-)coital sexual activity,
treatment-related distress, psychological and sexual distress, and vaginal physical symptoms
(assessed during physical examination by the radiation oncologist), and improves/increases
generic-related health related quality of life related to gynaecological cancer, relationship
satisfaction, and frequency of dilator use, (Q2); to evaluate the cost-effectiveness of the
intervention (Q3); and to evaluate whether an improvement in sexual functioning is moderated
by treatment characteristics and pre-treatment patient characteristics, such as age or sexual
functioning, and mediated by reduction of vaginal symptoms (and by regular use of dilators in
women treated with RTBT) (Q4).
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