1. Compare generic and pelvic-floor-specific QOL in patients who have been treated or gynaecologic cancer to that of patients without cancer attending a gynaecologist for pelvic floor symptoms.2. Examine how many and which patients receive or haveā¦
ID
Source
Brief title
Condition
- Other condition
- Reproductive neoplasms male malignant and unspecified
- Obstetric and gynaecological therapeutic procedures
Synonym
Health condition
bekkenbodemklachten
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pelvic floor specific QOL
Received medical help for pelvic floor symptoms
Secondary outcome
Prognostic factors / independent factors for seeking medical help: we will
collect demographic and clinical variables to find this out.
Background summary
The prevalence of de-novo pelvic floor symptoms following surgery and/or
radiotherapy because of cervical, endometrial or vulvar cancer is high. These
symptoms involve micturition symptoms, defecation symptoms, and problems with
sexual functioning. It has been hypothesized that these symptoms result from
damage to innervation, vascularisation and anatomical relation of the visceral
organs in the pelvic cavity. Next to the questionnaires we wil collect
demographic and clinical data to try to find something out about prognostic or
independent factors for seeking medical help.
To date, no studies exist that examine the extent to which gynaecologic cancer
patients experience a comparable level of generic and pelvic-floor-specific
quality of life (QOL) in comparison to patients without cancer who visit the
clinic because of pelvic floor symptoms. Furthermore it is unclear how many and
which cancer patients seek medical help for pelvic floor symptoms. Finally we
do not know which personal, doctor-related or health-system related factors
keep gynaecologic cancer patients with pelvic floor symptoms from seeking help.
Study objective
1. Compare generic and pelvic-floor-specific QOL in patients who have been
treated or gynaecologic cancer to that of patients without cancer attending a
gynaecologist for pelvic floor symptoms.
2. Examine how many and which patients receive or have received medical help
for pelvic floor symptoms.
3. Identify the factors associated with receiving medical help.
4. Explore the factors associated with not having sought medical help because
of pelvic floor symptoms following treatment of gynaecologic cancer.
Study design
We will perform a cross-sectional study in patients treated the last 10 years
in the Academic Medical Centre Amsterdam (AMC) for gynaecologic cancer. We will
send them after having received informed consent, questionnaires and compare
these results to a clinical sample. The clinical sample consists of patients
attending the gynaecologist because of micturition-, defecation- and sexual
symptoms.
All patients who never sought medical help for pelvic symptoms and who have a
pelvic floor symptom score comparable to scores of the clinical sample will be
invited to the hospital. We will conduct a semi-structured interview with these
patients to explore the reasons why they did not seek medical help because of
pelvic floor symptoms. Then we will also examine the pelvis for pelvic floor
problems according to the recommendations of the International Continence
Society.
Study burden and risks
questionnaires: no health risk. it will take around 1 hour to fill them in.
interview: no health risk. it will take 30 to 60 minutes. the journey will be
financially compensated.
Pelvic floor examination: low burden, no health risk. it will take 5-10
minutes.
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Meibergdreef 9
1105 AZ Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Patients treated in the last ten years in the Academic Medical Centre Amsterdam for cervical cancer, endometrial cancer or vulva cancer.
Exclusion criteria
Patients with other gynaecologic malignancies than defined in the inclusion criteria
Life expectancy of less than 3 months
Insufficient knowledge of the Dutch language
Presence of more than one primary malignancy
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL17850.018.07 |