ClinicalTrials.gg
CompletedNCT06958068SHIFT-GOUpdated Aug 21, 2025

Sexual Health Integration in Treatment of Gynecological Oncology

An observational study in Ovarian Cancer, Endometrial Cancer and Cervical Cancers, sponsored by Medical University of Silesia. Completed at 1 site in Poland. Open to female participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2025-08-21.

Sponsored by Medical University of Silesia · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
324
Ages
18 Years to 85 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 97 studies in Ovarian Neoplasms with a site in Poland — 20 open to participants now, 35 under way, 21 of them phase 3. Ovarian Neoplasms · Poland.

Enrollment
7th of 11
324 · median 500
Started
2022
with 7 others
Observational
11 of 97
3 open now
Registered
89th of 97
by date

Among the 97 studies in Ovarian Neoplasms with a site in Poland, this one is the 7th largest by enrollment of the 11 observational ones, is one of 8 that started in 2022, is one of 11 observational ones, and was the 89th registered.

By phase

97 studies; the count open now beside each. This study's row is marked.

Phase 346 · 8 open
Phase 222 · 3 open
Observationalthis study11 · 3 open
Phase 1/28 · 2 open
Phase 15 · 1 open
No phase2 · 2 open
Phase 2/32 · 1 open
Phase 41 · 0 open

By the year they started

First in 1999; this study’s year is marked. 8 started in 2022.

Size and results

Median enrollment 334 across the 86 interventional studies, 500 across the 11 observational. Of the 59 that completed or were terminated, 34 (58%) have results posted.

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Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 97 studies in Ovarian Neoplasms with a site in Poland, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
Female
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)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • diagnosed with breast cancer
  • currently being treated for gynecological or other
  • >2
  • not being able to have any type of sexual activity due to physical limitations or comorbidities
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
324 participants (actual)
Patient registry
No

Groups and cohorts

  • Women diagnosed with gynecological cancer after treatment completion

    Observational questionnaire-based study

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At least 8 weeks post treatment completion

Secondary outcomes

  1. 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.

    Time frame: At least 8 weeks post treatment completion

  2. 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

    Time frame: At least 8 weeks post treatment completion

07

Study locations

1 site
  • Department of Gynaecology, Obstetrics and Gynaecological Oncology, University Clinical Centre, Medical University of Silesia
    Katowice, Silesian Voivodeship 40-752, Poland
08

References and documents

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 30385228 ↗
  • 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. PubMed 35568382 ↗
  • 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. PubMed 37266338 ↗

Individual participant data

Plan to share: Yes — All anonymized data will be available

Supporting information: Study protocol, Clinical study report

Time frame: 31.12.2025

Access criteria: On request

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2022 to primary completion in Jan 2024, 24 months.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 27, 2025
First posted
May 6, 2025
StartActual
Jan 1, 2022
Primary completionActual
Jan 1, 2024
CompletionActual
Apr 25, 2025
Last update
Aug 21, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06958068
Responsible party
Krzysztof Nowosielski (profesor, Medical University of Silesia) — Principal investigator
First posted
May 6, 2025
Start date
Jan 1, 2022
Primary completion
Jan 1, 2024
Completion
Apr 25, 2025
Last update
Aug 21, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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