NCT06966791

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress86%
Dec 2024Jul 2026

Study Start

First participant enrolled

December 30, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 13, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2026

Expected
Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

May 4, 2025

Last Update Submit

February 19, 2026

Conditions

Keywords

sexual functionsbreast cancer surgeryyoung adult femalesBreast Cancer Treatmentquality of lifebreast cancer survivalbody perceptionMastectomyMastectomy, Modified RadicalMastectomy, Segmentalbreast conserving surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    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

    It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.

  • Participants' body perception

    It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.

Study Arms (1)

Young women with breast cancer

Sexually active young women scheduled for breast cancer surgery

Other: No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery

Interventions

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.

Young women with breast cancer

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Individuals who are followed up by Pamukkale University Breast Polyclinic

You may qualify if:

  • Individuals scheduled for surgery for breast cancer
  • Accepting to participate in the study
  • Being sexually active in the last 1 year
  • Continuation of menstruation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Atiye KAŞ ÖZDEMİR, Lecturer PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2025

First Posted

May 13, 2025

Study Start

December 30, 2024

Primary Completion

July 25, 2025

Study Completion (Estimated)

July 25, 2026

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations