Distress, Anxiety and Psychosexual Health in BOT

NCT04253327 | Completed

• 1 other identifier: sBOT D/A/PSH
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasm Epithelial Borderline

Keywords

low malignant potential; sexual health; anxiety; distress; surgery

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  2020

Study Arms (2)

BOT

Patients diagnosed and treated by surgery for borderline ovarian tumor

Other: questionnaire

controls

Patients after surgical treatment of benign ovarian tumor

Other: questionnaire

Interventions

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..

BOT; controls

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having had surgery for benign or borderline ovarian tumors

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

Universitair Ziekenhuis UZBrussel

Jette, Brussels Capital, 1090, Belgium

Location

Related Publications (1)

• 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.

  PMID: 39301872 DERIVED

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: February 5, 2020
• Study Start: September 1, 2020
• Primary Completion: February 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)