Clinical trial NCT06958068: Sexual Health Integration in Treatment of Gynecological Oncology
Official title: Integrating Mandatory Sexual Health Counseling in Gynaecological Oncology: A Paradigm Shift From Diagnosis to Survivorship.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Endometrial Cancer
Cervical Cancers
Vaginal Cancers
Sexual Health Quality of Life
Sexual Counselling
Keywords: gynecological cancer
sexual health
sexual counselling
paradigma
sexual activity
Lead sponsor: Medical University of Silesia
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 324
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women diagnosed with ovarian, cervical, endometrial, vulvar and vaginal cancer after completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)

Brief summary: The goal of this cross-section observational and questionary based study is to learn how geological cancer survivors perceive sexual health support given by health care professionals during diagnosis and treatment process.

The main question to be answered is:

Who, when and to what extend should discuss the sexual health issues

The participants will answer online survey questions about Sexual health issues and Sexual counselling during diagnosis, treatment and follow-up.

Detailed description: The main aim of the study is to verify who, from medical specialist, should discuss the sexual health issues in gynecological cancer survivors, when that discussion should take places and to what exited all sexual issues should be discusses.

The secondary end points are:

* to establish factors affecting returning to sexual activities defined as any type of physical contact with a partner engaging sexual organs as well as mutual and solo masturbation.
* to verified if gender of counselling specialist is important to patients.

The study is a cross-section observation one. It is based on a survey containing questions regarding basic socioeconomical factors, treatment history, reproductive history, and those concerning the opinion who, when, to what extend and how should ask about sexual issues during therapy modalities planning, treatment and follow-up.

Women after completing a treatment irrespectively of its type (surgery, radiation, chemotherapy, immune check point inhibitors) will be eligible for the study. Those who are no more sexually active and currently have no sexual partner will also be included.

After collecting the date three main analysis will be conducted to answer the study questions.

The results will be used as a basic for further work on recommendation on sexual health counselling in gynecological malignancies.

Eligibility criteria: Inclusion Criteria:

* diagnosed with gynecological malignancies except breast cancer
* completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)
* ECOG≤2

Exclusion Criteria:

* diagnosed with breast cancer
* currently being treated for gynecological or other malignancies
* ECOG \>2
* not being able to have any type of sexual activity due to physical limitations or comorbidities

Primary outcomes:
measure: Who should counsel patients with gynecological maligancies
timeFrame: At least 8 weeks post treatment completion
Secondary outcomes:
measure: Gender of gynecological oncologist counselling the patient
timeFrame: At least 8 weeks post treatment completion
measure: Returning to sexual activity defining as any sexual contact with a partner or solo masturbation
timeFrame: At least 8 weeks post treatment completion
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
state: Slaskie
Study officials:
References:
citation: Kowalczyk R, Nowosielski K, Cedrych I, Krzystanek M, Glogowska I, Streb J, Kucharz J, Lew-Starowicz Z. Factors Affecting Sexual Function and Body Image of Early-Stage Breast Cancer Survivors in Poland: A Short-Term Observation. Clin Breast Cancer. 2019 Feb;19(1):e30-e39. doi: 10.1016/j.clbc.2018.09.006. Epub 2018 Sep 21.
citation: Kacperczyk-Bartnik J, Nowosielski K, Razumova Z, Bizzarri N, Pletnev A, Lindquist D, Lanner M, Nikolova T, Theofanakis C, Strojna AN, Bartnik P, Gomez-Hidalgo NR, Vlachos DE, Selcuk I, Zalewski K. Clinician attitude towards sexual counseling in women with gynecologic malignancies: European Network of Young Gynaecological Oncologists (ENYGO) survey. Int J Gynecol Cancer. 2022 Oct 3;32(10):1309-1315. doi: 10.1136/ijgc-2021-003309.
citation: Nowosielski K, Palka A. Couples' sexual health after gynaecological cancer diagnosis - an unexplored area for further research. Contemp Oncol (Pozn). 2023;27(1):47-56. doi: 10.5114/wo.2023.127308. Epub 2023 Apr 27.