Breast Cancer SurgeryNCT06966791
Sexual Functıon in Young Women After Breast Cancer Surgery
An observational study of Breast Cancer Surgery and Young Adult Females, run by ATİYE KAŞ ÖZDEMİR at 1 site in Turkey (Türkiye).
Trial summary
The aim of this observational study was to analyse sexual function in young women after breast cancer surgery. The main question it aims to answer is Sexual function in young women after breast cancer surgery changes during the one-year follow-up period. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Breast Cancer Surgery, Young Adult Females
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2024to 25 Jul 2026
- 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 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Individuals who are followed up by Pamukkale University Breast Polyclinic
Who may be able to join
- Individuals scheduled for surgery for breast cancer
- Accepting to participate in the study
- Being sexually active in the last 1 year
- Continuation of menstruation
Who cannot join
- Previous breast cancer surgery
- Previous history of breast cancer
- History of any other cancer
- Refusal to participate in the study
- Refusal to continue working
- Problems in her relationship with her partner
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examınatıon of Sexual Functıon in Young Women After Breast Cancer Surgery
The aim of this observational study was to analyse sexual function in young women after breast cancer surgery. The main question it aims to answer is Sexual function in young women after breast cancer surgery changes during the one-year follow-up period. Participants will answer demographic information, Female Sexual Function Scale, Breast-Q and Body Perception Scale about their sexual function, quality of life and body perception. These will be recorded before surgery and repeated 6 weeks, 6 months and 1 year after surgery.
Read the detailed description
As a result of the power analysis of the preliminary study conducted with the participation of 9 cases; it was calculated that 80% power could be obtained at 95% confidence level when at least 47 people were included in the study. However, considering that the results of the preliminary study will not be conclusive, it is planned to complete the study with at least 52 people by taking 10% more participants. The data will be analysed with SPSS 25.0 package programme. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. Repeated measures ANOVA test, Kruskal-Wallis test or Friedman test will be used according to the parametric test assumptions.
- Conditions
- Breast Cancer Surgery, Young Adult Females
- Being tested
- No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery
- Keywords
- sexual functions, breast cancer surgery, young adult females, Breast Cancer Treatment, quality of life, breast cancer survival, body perception, Mastectomy, Mastectomy, Modified Radical, Mastectomy, Segmental, breast conserving surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgeryOther
No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery and other breast cancer treatments.
| Study group | Role | What they receive |
|---|---|---|
| Young women with breast cancer | Sexually active young women scheduled for breast cancer surgery Receives: Other: No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual function
In this study, it is planned to follow up the patients from the early postoperative period in order to emphasise and draw attention to the difficulties experienced by individuals with breast cancer in their sexual life. Female sexual function will evaluate with a detailed 19-item likert-type questionnaire [Female Sexual Function Index (FSFI)] described by Rosen et al.
Questions 1 and 2 are scored between 1-5, questions 3-13 are scored between 0-5, questions 14-16 are scored between 0 and 1-5 and questions 17-19 are scored between 0-5. Accordingly, the highest raw score to be obtained from the scale is 95 and the lowest raw score is 4. The cut-off score of the scale is determined as 26.55 and it is stated that women who score below this score have sexual dysfunction (Aydemir and Güneş 2024). High scores on the scale indicate that sexual function is good. The Turkish validity and reliability study of the scale was conducted by Aygin and Aslan in 2005.
Measured: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
Secondary outcomes (2)
Quality of life of participants
Breast-Q, a validated, patient-reported outcome measure, will be used to assess the satisfaction and quality of life of patients undergoing breast cancer surgery.The breast satisfaction section consists of 4 questions scored 1-4, the psychosocial well-being section consists of 10 questions scored 1-5, the sexual well-being section consists of 6 questions scored 1-5, the physical well-being section consists of 10/11 questions scored 1-3, and the radiation side effects section consists of 6 questions scored 1-3. Higher scores represent better results.
Measured: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
Participants' body perception
The Body Perception Scale developed by Secord and Jourand will be used to evaluate the body perception of the participants.The scale consists of 40 items, each item related to an organ or a part or function of the body. The scale, which offers a Likert-type scoring between 1-5 for each item as 'I don't like it at all', 'I don't like it', 'I don't like it', 'I am undecided', 'I like it' and 'I like it very much', is scored between 40-200 in total. The cut-off score of the scale is 135, and those with a score below 135 are defined as the group with low body image (Hamurcu et al. 2015).
Measured: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start30 Dec 2024
- Primary completion25 Jul 2025
- Study completion25 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer SurgeryStudies 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
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- ATİYE KAŞ ÖZDEMİR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ATİYE KAŞ ÖZDEMİR, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06966791
- Sponsor's protocol ID
- E-60116787-020-631173
- Status last verified
- Sep 2026
- First submitted
- 4 May 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examınatıon of Sexual Functıon in Young Women After Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT06966791
- Acronym / sponsor ID
- E-60116787-020-631173
- Conditions
- Breast Cancer Surgery, Young Adult Females
- Keywords
- sexual functions, breast cancer surgery, young adult females, Breast Cancer Treatment, quality of life, breast cancer survival, body perception, Mastectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ATİYE KAŞ ÖZDEMİRUniversity, hospital or other
- Study start
- 30 Dec 2024 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2026 (actual)
- First posted
- 13 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 aim of this observational study was to analyse sexual function in young women after breast cancer surgery. The main question it aims to answer is Sexual function in young women after breast cancer surgery changes during the one-year follow-up period. Participants will answer demographic information, Female Sexual Function Scale, Breast-Q and Body Perception Scale about their sexual function, quality of life and body perception. These will be recorded before surgery and repeated 6 weeks, 6 months and 1 year after surgery.
Detailed description
As a result of the power analysis of the preliminary study conducted with the participation of 9 cases; it was calculated that 80% power could be obtained at 95% confidence level when at least 47 people were included in the study. However, considering that the results of the preliminary study will not be conclusive, it is planned to complete the study with at least 52 people by taking 10% more participants. The data will be analysed with SPSS 25.0 package programme. Continuous variables will be given as mean ± standard deviation and categorical variables as number and percentage. Repeated measures ANOVA test, Kruskal-Wallis test or Friedman test will be used according to the parametric test assumptions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Young women with breast cancer | – | Other: No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgerySexually active young women scheduled for breast cancer surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Individuals who are followed up by Pamukkale University Breast Polyclinic
Key inclusion criteria (4 listed)
- Individuals scheduled for surgery for breast cancer
- Accepting to participate in the study
- Being sexually active in the last 1 year
- Continuation of menstruation
Key exclusion criteria (6 listed)
- Previous breast cancer surgery
- Previous history of breast cancer
- History of any other cancer
- Refusal to participate in the study
- Refusal to continue working
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgeryNo intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery and other breast cancer treatments. | Other | Young women with breast cancer |
Primary outcome
Sexual function
Time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
In this study, it is planned to follow up the patients from the early postoperative period in order to emphasise and draw attention to the difficulties experienced by individuals with breast cancer in their sexual life. Female sexual function will evaluate with a detailed 19-item likert-type questionnaire [Female Sexual Function Index (FSFI)] described by Rosen et al. Questions 1 and 2 are scored between 1-5, questions 3-13 are scored between 0-5, questions 14-16 are scored between 0 and 1-5 and questions 17-19 are scored between 0-5. Accordingly, the highest raw score to be obtained from the scale is 95 and the lowest raw score is 4. The cut-off score of the scale is determined as 26.55 and it is stated that women who score below this score have sexual dysfunction (Aydemir and Güneş 2024). High scores on the scale indicate that sexual function is good. The Turkish validity and reliability study of the scale was conducted by Aygin and Aslan in 2005.
2 secondary outcomes
Quality of life of participants
Time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
Participants' body perception
Time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
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 22 Sep 2026.
- Individual participant dataSharing planned: No
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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 Breast Cancer Surgery and Young Adult Females, run by ATİYE KAŞ ÖZDEMİR at 1 site in Turkey (Türkiye).
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 4 inclusion and 6 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 22 Sep 2026. 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 Turkey (Türkiye). 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?
Sexual function (time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2026.