Sexual Functıon in Young Women After Breast Cancer Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorATİYE KAŞ ÖZDEMİR
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals scheduled for surgery for breast cancer
Accepting to participate in the study
Being sexually active in the last 1 year
Continuation of menstruation
Disqualifiers
Previous breast cancer surgery
Previous history of breast cancer
History of any other cancer
Refusal to participate in the study
Trial population
Individuals who are followed up by Pamukkale University Breast Polyclinic
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
No intervention will be performed as part of this study. However, regardless of the study, all participants will have breast cancer surgery
Other interventionNo 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.
Treatment groups
52 Participants
are divided into 1 treatment groupGroup A: Young women with breast cancer1 intervention
Trial outcomes
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.
Time frame
It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.Secondary outcomes
1
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.
Time frame
It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.2
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).
Time frame
It is planned to repeat the measurements 4 times: before, 6 weeks, 6 months and 12 months after breast cancer surgery.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
ATİYE KAŞ ÖZDEMİR
Lead sponsor
Pamukkale University
Sponsor institution
Source ClinicalTrials.gov