Sexual Health Integration in Treatment of Gynecological Oncology (SHIFT-GO)

August 15, 2025 updated by: Krzysztof Nowosielski, Medical University of Silesia

Integrating Mandatory Sexual Health Counseling in Gynaecological Oncology: A Paradigm Shift From Diagnosis to Survivorship.

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

324

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Slaskie
      • Katowice, Slaskie, Poland, 40-752
        • Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Women diagnosed with gynecological cancer after treatment completion
Observational questionnaire-based study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Who should counsel patients with gynecological malignancies
Time Frame: At least 8 weeks post treatment completion
A set of questions were asked to verify the hypothesis that specialist in gynecological oncology should inform about sexual issues during the treatment ant after its completion. Timing, frequency of counselling and patients' preferences for sexual information sources were established.
At least 8 weeks post treatment completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Returning to sexual activity defining as any sexual contact with a partner or solo masturbation
Time Frame: At least 8 weeks post treatment completion
A set of question were asked to verify factors that might influence returning to sexual activity after treatment completion
At least 8 weeks post treatment completion
Gender of gynecological oncologist counselling the patient
Time Frame: At least 8 weeks post treatment completion
A set of questions were ask to verify the hypothesis that in case of cancer choosing the specialist in gynecological oncology in not gender-based but knowledge and skills-based.
At least 8 weeks post treatment completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

April 25, 2025

Study Registration Dates

First Submitted

April 27, 2025

First Submitted That Met QC Criteria

April 27, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

August 21, 2025

Last Update Submitted That Met QC Criteria

August 15, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KB/96/FI/2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All anonymized data will be available

IPD Sharing Time Frame

31.12.2025

IPD Sharing Access Criteria

On request

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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