Brief Title
Sexual Rehabilitation Programme After Radiotherapy for Gynaecological Cancer
Official Title
SPARC Study: A Nurse-led Sexual Rehabilitation Programme for Women With Gynaecological Cancers Receiving Radiotherapy: a Randomized Multicentre Trial
Brief Summary
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.
Detailed Description
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).
Study Type
Interventional
Primary Outcome
Change from 1 month in Sexual functioning at 12 months post RT/RTBT
Secondary Outcome
Changes from 1 month in Vaginal symptoms and body image concerns at 12 months post RT/RTBT
Condition
Endometrial Cancer
Intervention
Sexual rehabilitation programme
Study Arms / Comparison Groups
Sexual rehabilitation programme
Description: The intervention exists of a nurse-led sexual rehabilitation programme, which is provided in addition to the care as usual. The intervention consists of four one-hour sessions at 1 month, 3, 6, and 12 months after RT. Women treated with RTBT will receive an additional appointment with the nurse (2 months after RTBT). Furthermore, the latter group receives a vaginal dilator set.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
220
Start Date
August 7, 2018
Completion Date
July 2022
Primary Completion Date
July 2022
Eligibility Criteria
Inclusion Criteria:
- being diagnosed with on of the following gynaecological cancers: cervical cancer,
endometrial cancer or vaginal cancer
- 18 years or older
- receiving radiotherapy for gynaecological cancer (RT/RTBT)
- wish to retain sexual activity in the short- or long-term.
Exclusion Criteria:
- being unavailable for follow-up
- having insufficient knowlegde of the Dutch language
- having a psychiatric disorder (e.g. major affective disorder, psychotic disorder,
substance abuse disorder (i.e., alcohol, drugs), or posttraumatic stress disorder
resulting from abuse in the pelvic floor and/or genitals (e.g., sexual abuse)).
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Moniek M ter Kuile, PhD, 0031715263121, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT03611517
Organization ID
P17.317
Secondary IDs
10674
Responsible Party
Principal Investigator
Study Sponsor
Leiden University Medical Center
Collaborators
Dutch Cancer Society
Study Sponsor
Moniek M ter Kuile, PhD, Study Chair, Leiden University Medical Center
Verification Date
February 2020