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Completed

NCT Number: NCT04253327

Distress, Anxiety and Psychosexual Health in BOT

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.

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Key information

Conditions

Ovarian Neoplasm Epithelial Borderline Anxiety Disorders Mental Disorders

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, 1090, Belgium

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Other

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..

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

Impact of Diagnosis and Surgical Treatment of Borderline Ovarian Tumors on Distress, Anxiety and Psychosexual Health

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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