Ovarian CancerSHIFT-GONCT06958068
Sexual Health Integration in Treatment of Gynecological Oncology
An observational study of Ovarian Cancer and Endometrial Cancer, run by Medical University of Silesia at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years, women only
- Conditions the study is for
- Ovarian Cancer, Endometrial Cancer, Cervical Cancers
- How many people
- 324 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2022to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women diagnosed with ovarian, cervical, endometrial, vulvar and vaginal cancer after completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)
Who may be able to join
- diagnosed with gynecological malignancies except breast cancer
- completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)
- ECOG≤2
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
Katowice, Silesian Voivodeship, 40-752
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms, Vaginal Neoplasms, Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Women diagnosed with gynecological cancer after treatment completion | Observational questionnaire-based study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Who should counsel patients with gynecological malignancies
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.
Measured: At least 8 weeks post treatment completion
Secondary outcomes (2)
Gender of gynecological oncologist counselling the patient
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.
Measured: At least 8 weeks post treatment completion
Returning to sexual activity defining as any sexual contact with a partner or solo masturbation
A set of question were asked to verify factors that might influence returning to sexual activity after treatment completion
Measured: At least 8 weeks post treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2025
- Study start1 Jan 2022
- Primary completion1 Jan 2024
- Study completion25 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krzysztof Nowosielski, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06958068
- Sponsor's protocol ID
- KB/96/FI/2018
- Acronym
- SHIFT-GO
- Status last verified
- Aug 2025
- First submitted
- 27 Apr 2025
- Last updated
- 21 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized data will be available
Publications
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.
PubMed 30385228Kacperczyk-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.
PubMed 35568382Nowosielski 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.
PubMed 37266338Nowosielski K, Kacperczyk-Bartnik J, Bizon M. Patient preferences for sexual health counseling across the Gynecologic Cancer Care Continuum: the sexual health integration in treatment of gynecological oncology (SHIFT-GO Study). Int J Gynecol Cancer. 2026 Aug;36(8):104817. doi: 10.1016/j.ijgc.2026.104817. Epub 2026 Jun 20.
PubMed 42480165
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Mandatory Sexual Health Counseling in Gynaecological Oncology: A Paradigm Shift From Diagnosis to Survivorship.
- ClinicalTrials.gov ID
- NCT06958068
- Acronym / sponsor ID
- SHIFT-GO / KB/96/FI/2018
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 6 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women diagnosed with gynecological cancer after treatment completion | – | –Observational questionnaire-based study |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women diagnosed with ovarian, cervical, endometrial, vulvar and vaginal cancer after completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)
Key inclusion criteria (3 listed)
- diagnosed with gynecological malignancies except breast cancer
- completion of treatment irrespectively of its type (surgery, CTH, RTH, immunotherapy)
- ECOG≤2
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Gender of gynecological oncologist counselling the patient
Time frame: At least 8 weeks post treatment completion
Returning to sexual activity defining as any sexual contact with a partner or solo masturbation
Time frame: At least 8 weeks post treatment completion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2025.
- Background: PubMed 30385228Kowalczyk 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.
- Background: PubMed 35568382Kacperczyk-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.
- Background: PubMed 37266338Nowosielski 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.
- Derived from this study: PubMed 42480165Nowosielski K, Kacperczyk-Bartnik J, Bizon M. Patient preferences for sexual health counseling across the Gynecologic Cancer Care Continuum: the sexual health integration in treatment of gynecological oncology (SHIFT-GO Study). Int J Gynecol Cancer. 2026 Aug;36(8):104817. doi: 10.1016/j.ijgc.2026.104817. Epub 2026 Jun 20.
- Individual participant dataSharing planned: Yes. All anonymized data will be available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer and Endometrial Cancer, run by Medical University of Silesia at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Who should counsel patients with gynecological malignancies (time frame: At least 8 weeks post treatment completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06958068, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.