- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04253327
Distress, Anxiety and Psychosexual Health in BOT
Impact of Diagnosis and Surgical Treatment of Borderline Ovarian Tumors on Distress, Anxiety and Psychosexual Health
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Stefan Cosyns, MD
- Phone Number: +32 24776020
- Email: scosyns@uzbrussel.be
Study Locations
-
-
Brussels
-
Jette, Brussels, Belgium, 1090
- Recruiting
- Universitair Ziekenhuis UZBrussel
-
Contact:
- Stefan Cosyns, Md
- Phone Number: 0032 24776020
- Email: Scosyns@uzbrussel.be
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BOT
Patients diagnosed and treated by surgery for borderline ovarian tumor
|
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
|
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.. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2020
|
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.
|
2020
|
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. |
2020
|
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.
|
2020
|
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.
|
2020
|
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.
|
2020
|
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.
|
2020
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- sBOT D/A/PSH
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ovarian Neoplasm Epithelial Borderline
-
National Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Fallopian Tube Carcinoma | Primary Peritoneal Carcinoma | Stage IV Ovarian Cancer | Stage III Ovarian Cancer | Recurrent Borderline Ovarian Surface Epithelial-Stromal Tumor | Stage III Borderline Ovarian Surface Epithelial-Stromal Tumor | Stage IV Borderline Ovarian...Canada
-
Barbara Ann Karmanos Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Ovarian Carcinoma | Ovarian Neoplasm | Ovarian Clear Cell Tumor | Adnexal Mass | Ovarian Endometrioid Tumor | Ovarian Serous Tumor | Borderline Ovarian Epithelial TumorUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedPrimary Peritoneal Carcinoma | Low Grade Ovarian Serous Adenocarcinoma | Borderline Ovarian Serous Tumor | Micropapillary Serous Carcinoma | Primary Peritoneal Low Grade Serous Adenocarcinoma | Recurrent Borderline Ovarian Surface Epithelial-Stromal TumorUnited States
-
Lei LiUnknownEpithelial Ovarian Cancer | Progression-free Survival | Epithelial Ovarian Tumor of Borderline Malignancy | Driving MutationsChina
-
Health Science Center of Xi'an Jiaotong UniversityRecruitingOvarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, OvarianChina
-
Royal Surrey County Hospital NHS Foundation TrustUnknownOvarian Cancer | Fallopian Tube Cancer | Peritoneal Cancer | Ovarian Neoplasm | Ovarian Neoplasm EpithelialUnited Kingdom
-
National Cancer Institute, NaplesRecruitingLow-grade Serous Ovarian Carcinoma | Recurrent Invasive Borderline Serous Ovarian CancerItaly
-
Azaya Therapeutics, Inc.UnknownCancer | Ovarian Cancer | Ovarian Epithelial Cancer Recurrent | Malignant Female Reproductive System Neoplasm | Ovarian TumorCanada, United States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)CompletedAdvanced Malignant Solid Neoplasm | Refractory Malignant Solid Neoplasm | Ovarian Carcinoma | Refractory Ovarian CarcinomaUnited States
-
ZIWIGMonitoring Force Group; iGenSeqRecruitingOvarian Cancer | Ovarian Cyst Benign | Borderline Ovarian CancerFrance
Clinical Trials on questionnaire
-
H. Lee Moffitt Cancer Center and Research InstituteSan Diego State University; University of Minnesota; University of ArizonaCompletedAnxiety | Psychological StressUnited States
-
Centre Hospitalier Universitaire de NiceCompletedGeneral Population | TDAH | Children Aged 5 to 18 YearsFrance
-
Imperial College LondonRoyal Marsden NHS Foundation Trust; University College London Hospitals; The... and other collaboratorsCompleted
-
Minneapolis Veterans Affairs Medical CenterUnited States Department of DefenseCompletedLower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury)United States
-
NSABP Foundation IncNational Cancer Institute (NCI)Completed
-
Stanford UniversityRecruitingAstigmatism | Nearsightedness | FarsightednessUnited States
-
University of LiegeCompletedCritical Illness | Covid19 | Psychological Stress | FamilyBelgium
-
Imperial College Healthcare NHS TrustNot yet recruitingCervical Myelopathy
-
Rabin Medical CenterCompleted
-
National Taiwan University HospitalNational Taiwan UniversityUnknownComputerized Physician Order EntryTaiwan