Clinical trial NCT04253327: Distress, Anxiety and Psychosexual Health in BOT
Official title: Impact of Diagnosis and Surgical Treatment of Borderline Ovarian Tumors on Distress, Anxiety and Psychosexual Health
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ovarian Neoplasm Epithelial Borderline
Keywords: low malignant potential
sexual health
anxiety
distress
surgery
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having had surgery for benign or borderline ovarian tumors

Brief summary: The aim of this study is to assess the prevalence of distress, anxiety and psychosexual anguish in patients diagnosed with borderline ovarian tumor (BOT) compared to controls confronted with surgical treatment for benign ovarian tumors.

Detailed description: Appropriate surgical care is primordial for the patient after diagnosis of a BOT. Taking into account the good prognosis and long live expectancy caregivers should also be concerned about non-oncological complains during the follow-up to guarantee the overall well-being of the patient.

Women diagnosed with gynaecological cancer are likely to face additional consequences beyond those common to all cancer patients.

Not surprisingly, previous research shows that women affected by gynaecological cancer are likely to suffer significant physical and psychological morbidity. Studies including women of all ages with gynaecological cancers indicate higher levels of psychological distress, including clinical levels of anxiety, depression and posttraumatic distress disorder as well as greater decrements in body image and more sexual problems than in other types of cancer. High levels of distress were reported up to four years following the diagnosis.

Longitudinal studies addressing the prevalence of psychological distress, anxiety or psychosexual health during follow up in BOT patients are lacking. Due to the connotation between sexuality and internal genitals, diagnosis of the BOT and following surgery are possibly negatively influencing each other. Large prospective or randomized control studies are unachievable due to the low prevalence of BOT and limited recurrences or death.

Identification of the presence of psychological morbidity, including anxiety and depression is clinically useful because, unlike most demographic and clinical factors, psychological illness and psychosexual complaints are modifiable.

The study material consists out of two main parts of questionnaires.

A first questionnaire addressing the distress and anxiety consists of validated questionnaires:

* Hospital Anxiety and Depression Scale (HADS),
* Body Image Scale (BIS),
* Perceived Stress Scale (PSS).

And a second questionnaire concerning psychosexual health, built up out of validated questionnaires;

* Female Sexual Function Index (FSFI),
* Female Sexual Distress Scale - Revised (FSDS-R),
* European Organisation for Research and Treatment of Cancer (EORTC) quality of life (QOL) questionnaire designed to measure the QOL of patients with ovarian cancer (EORTC QLQ-OV28) (only questions 50-58)
* EORTC Sexual Health Questionnaire (EORTC SHQ-C22) for assessing sexual health in cancer patients (only the part concerning women).

Eligibility criteria: Inclusion Criteria:

* Diagnosis and surgery for benign or borderline ovarian tumors.
* \>18 y.

Exclusion Criteria:

* Known former psychological morbidity evaluated by the investigators.
* History of another cancer type.

Primary outcomes:
measure: Anxiety and Depression - HADS
timeFrame: 2020
measure: Depression - BIS
timeFrame: 2020
measure: Anxiety - Perceived Stress Scale
timeFrame: 2020
measure: Psycho-sexual health - FSFI
timeFrame: 2020
measure: Psycho-sexual health - FSDS - Revised
timeFrame: 2020
measure: Psycho-sexual health - EORTC OV28
timeFrame: 2020
measure: Psycho-sexual health - EORTC SHQ C22
timeFrame: 2020
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis UZBrussel
state: Brussels
Study officials:
References: