NCT Number: NCT06966791
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.
Interested in participating?
Request Info18 year–50 year
Female
Observational
Denizli, Turkey (Türkiye)
Location status: Recruiting
Atiye KAŞ ÖZDEMİR, Lecturer, PhD
CONTACT
Atiye KAŞ ÖZDEMİR, Lecturer, PhD.
PRINCIPAL_INVESTIGATOR
Derya KILIÇ, Assoc. Prof. Dr.
SUB_INVESTIGATOR
Orçin TELLİ ATALAY, Prof. Dr.
SUB_INVESTIGATOR
Sevda YILMAZ, Assoc. Prof. Dr.
SUB_INVESTIGATOR
Utku Özgen, Assoc. Prof. Dr.
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
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.
Time frame: It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.
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).
Contact information is provided by the study sponsor or research team.
ATİYE KAŞ ÖZDEMİR
Other
Examınatıon of Sexual Functıon in Young Women After Breast Cancer Surgery
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