Distress, Anxiety and Psychosexual Health in BOT

NCT ID: NCT04253327

Last Updated: 2023-05-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2023-09-01

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).

Conditions

Ovarian Neoplasm Epithelial Borderline

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

BOT

Patients diagnosed and treated by surgery for borderline ovarian tumor

questionnaire

Intervention Type: 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..

controls

Patients after surgical treatment of benign ovarian tumor

questionnaire

Intervention Type: 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..

Interventions

questionnaire

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..

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Stefan Cosyns

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Stefan Cosyns, MD

Role: CONTACT

scosyns@uzbrussel.be

24776020 ext. +32

Facility Contacts

Stefan Cosyns, Md

Role: primary

Scosyns@uzbrussel.be

24776020 ext. 0032

References

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.

Reference Type: DERIVED

PMID: 39301872 (View on PubMed)

Other Identifiers

sBOT D/A/PSH

Identifier Type: -

Identifier Source: org_study_id