Ovarian Neoplasm Epithelial BorderlineNCT04253327
Distress, Anxiety and Psychosexual Health in BOT
An observational study of Ovarian Neoplasm Epithelial Borderline, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Ovarian Neoplasm Epithelial Borderline
- What is being tested?
- questionnaire
- How many people
- 60 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2020to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients having had surgery for benign or borderline ovarian tumors
Who may be able to join
- Diagnosis and surgery for benign or borderline ovarian tumors.
- >18 y.
Who cannot join
- Known former psychological morbidity evaluated by the investigators.
- History of another cancer type.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Diagnosis and Surgical Treatment of Borderline Ovarian Tumors on Distress, Anxiety and Psychosexual Health
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.
Read the 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).
- Conditions
- Ovarian Neoplasm Epithelial Borderline
- Being tested
- questionnaire
- Keywords
- low malignant potential, sexual health, anxiety, distress, surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaireOther
Patients will be contacted by their physician during regular follow-up in the out-patient clinic or contacted by phone.
The questionnaires will be filled in at the UZBrussel, Laarbeeklaan 101, 1090 Brussels or at the patients home.
Filled-in questionnaires can be hand off immediately at the physician or send by post or email..
| Study group | Role | What they receive |
|---|---|---|
| BOT | Patients diagnosed and treated by surgery for borderline ovarian tumor Receives: Other: questionnaire | |
| controls | Patients after surgical treatment of benign ovarian tumor Receives: Other: questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depression - HADS
Anxiety and depression will be measured using a validated questionnaire: Hospital Anxiety and Depression Scale - The scores for anxiety and depression can vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms; a score between 8 and 10 indicates the presence of the symptoms but to a moderate degree, therefore doubtful cases; a score greater than or equal to 11 indicates a significant number of symptoms corresponding to confirmed cases.
Measured: 2020
Depression - BIS
Depression will be measured using two validated questionnaires. The first one will be the Body Image Scale (BIS). The BIS is a a 10-item scale informing about self-image. A low score is reflecting a low body image.
Measured: 2020
Anxiety - Perceived Stress Scale
The validated questionnaire measuring perceived stress among our study population will be the Perceived Stress Scale or PSS.
Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Measured: 2020
Psycho-sexual health - FSFI
Psychosexual health will be measured using different validated questionnaires: The First will be the Female sexual function index (FSFI). This is a 19-item questionnaire provides scores on six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. A score ≤ 26.55 is classified as a Female Sexual Disorder.
Measured: 2020
Psycho-sexual health - FSDS - Revised
Psycho-sexual health will be measured using different validated questionnaires: As second we will use is the Female sexual distress scale (FSDS-R), a 13-item questionnaire designed to measure sexually related personal distress in women. A low score reflects a normal sexual health whereas a high score an in-satisfaction about the sexual health reflects.
Measured: 2020
Psycho-sexual health - EORTC OV28
Psychosexual health will be measured using different validated questionnaires: The third questionnaire is one of the EORTC quality of life questionnaire for patient with ovarian cancer (EORTC QLQ-OV28). The EORTC QLQ questionnaire is designed to measure quality of life in cancer patients. A high score for the [functional scales and/or single items] represents a high level of functioning, whereas a high score for the [symptom scales and/or single items] represents a high level of symptomatology or problems.
Measured: 2020
Psycho-sexual health - EORTC SHQ C22
Psycho-sexual health will be measured using different validated questionnaires: The last questionnaire will be the EORTC Sexual health questionnaire for cancer patients (EORTC SHQ-C22). This questionnaires is designed to measure sexual health in cancer patients. A high score for the [functional scales and/or single items] represents a high level of functioning, whereas a high score for the [symptom scales and/or single items] represents a high level of symptomatology or problems.
Measured: 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start1 Sep 2020
- Primary completion1 Feb 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian Neoplasm Epithelial BorderlineStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Cosyns, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253327
- Sponsor's protocol ID
- sBOT D/A/PSH
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2020
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cosyns S, Dony N, Polyzos N, Buyl R, Tournaye H, Schotte C. Impact of diagnosis and surgical treatment of early stage borderline ovarian tumours on distress, anxiety, and psychosexual health. J Psychosom Obstet Gynaecol. 2024 Dec;45(1):2404010. doi: 10.1080/0167482X.2024.2404010. Epub 2024 Sep 20.
PubMed 39301872
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Diagnosis and Surgical Treatment of Borderline Ovarian Tumors on Distress, Anxiety and Psychosexual Health
- ClinicalTrials.gov ID
- NCT04253327
- Acronym / sponsor ID
- sBOT D/A/PSH
- Conditions
- Ovarian Neoplasm Epithelial Borderline
- Keywords
- low malignant potential, sexual health, anxiety, distress, surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BOT | – | Other: questionnairePatients diagnosed and treated by surgery for borderline ovarian tumor |
| controls | – | Other: questionnairePatients after surgical treatment of benign ovarian tumor |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having had surgery for benign or borderline ovarian tumors
Key inclusion criteria (2 listed)
- Diagnosis and surgery for benign or borderline ovarian tumors.
- >18 y.
Key exclusion criteria (2 listed)
- Known former psychological morbidity evaluated by the investigators.
- History of another cancer type.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnairePatients will be contacted by their physician during regular follow-up in the out-patient clinic or contacted by phone. The questionnaires will be filled in at the UZBrussel, Laarbeeklaan 101, 1090 Brussels or at the patients home. Filled-in questionnaires can be hand off immediately at the physician or send by post or email.. | Other | BOT, controls |
Primary outcome
Anxiety and Depression - HADS
Time frame: 2020
Anxiety and depression will be measured using a validated questionnaire: Hospital Anxiety and Depression Scale - The scores for anxiety and depression can vary from 0 to 21, depending on the presence and severity of the symptoms. A score between 0 and 7 does not indicate the presence of the symptoms; a score between 8 and 10 indicates the presence of the symptoms but to a moderate degree, therefore doubtful cases; a score greater than or equal to 11 indicates a significant number of symptoms corresponding to confirmed cases.
Depression - BIS
Time frame: 2020
Depression will be measured using two validated questionnaires. The first one will be the Body Image Scale (BIS). The BIS is a a 10-item scale informing about self-image. A low score is reflecting a low body image.
Anxiety - Perceived Stress Scale
Time frame: 2020
The validated questionnaire measuring perceived stress among our study population will be the Perceived Stress Scale or PSS. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress. Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Psycho-sexual health - FSFI
Time frame: 2020
Psychosexual health will be measured using different validated questionnaires: The First will be the Female sexual function index (FSFI). This is a 19-item questionnaire provides scores on six domains of sexual function (desire, arousal, lubrication, orgasm, satisfaction, and pain) as well as a total score. A score ≤ 26.55 is classified as a Female Sexual Disorder.
Psycho-sexual health - FSDS - Revised
Time frame: 2020
Psycho-sexual health will be measured using different validated questionnaires: As second we will use is the Female sexual distress scale (FSDS-R), a 13-item questionnaire designed to measure sexually related personal distress in women. A low score reflects a normal sexual health whereas a high score an in-satisfaction about the sexual health reflects.
Psycho-sexual health - EORTC OV28
Time frame: 2020
Psychosexual health will be measured using different validated questionnaires: The third questionnaire is one of the EORTC quality of life questionnaire for patient with ovarian cancer (EORTC QLQ-OV28). The EORTC QLQ questionnaire is designed to measure quality of life in cancer patients. A high score for the [functional scales and/or single items] represents a high level of functioning, whereas a high score for the [symptom scales and/or single items] represents a high level of symptomatology or problems.
Psycho-sexual health - EORTC SHQ C22
Time frame: 2020
Psycho-sexual health will be measured using different validated questionnaires: The last questionnaire will be the EORTC Sexual health questionnaire for cancer patients (EORTC SHQ-C22). This questionnaires is designed to measure sexual health in cancer patients. A high score for the [functional scales and/or single items] represents a high level of functioning, whereas a high score for the [symptom scales and/or single items] represents a high level of symptomatology or problems.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Derived from this study: PubMed 39301872Cosyns S, Dony N, Polyzos N, Buyl R, Tournaye H, Schotte C. Impact of diagnosis and surgical treatment of early stage borderline ovarian tumours on distress, anxiety, and psychosexual health. J Psychosom Obstet Gynaecol. 2024 Dec;45(1):2404010. doi: 10.1080/0167482X.2024.2404010. Epub 2024 Sep 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasm Epithelial Borderline, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety and Depression - HADS (time frame: 2020). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253327, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.