Clinical trial NCT06981910: The Role of Psychoeducation in Breast Cancer Care
Official title: The Effect of Psychoeducation on Body Image and Sexual Quality of Life in Patients Undergoing Mastectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychoeducation for Patients Who Have Undergone Mastectomy
Mastectomy
Keywords: Breast cancer
Mastectomy
Psychoeducation
Body image
Sexual quality of life
Lead sponsor: Dicle University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study was carried out as a two-group, parallel, randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to examine the effect of psychoeducation on body image and sexual quality of life in female patients who underwent mastectomy due to breast cancer.

Detailed description: Method: This randomized controlled trial with two parallel groups was conducted between October 2023 and January 2025 in the general surgery clinic of a university hospital. The sample consisted of 63 patients (31 in the psychoeducation group and 32 in the control group). Data collection was conducted using the Patient Information Form, the Breast Cancer Body Image Scale (BCBIS), and the Sexual Quality of Life-Female (SQoL-F) questionnaire. Following the pretest administered to all participants, patients in the psychoeducation group received a 6-week psychoeducation program (90 minutes per week). After the completion of the 6-week intervention, a 4-week waiting period was implemented, after which the posttest was administered to all participants. Data analysis included descriptive statistics, chi-square test, t-test, Kolmogorov-Smirnov test, Cronbach's alpha coefficient, ANOVA, and Bonferroni post hoc tests.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 and 60 years
* Married and/or with a partner,
* Residing in the city where this study was carried out,
* İnformed about their diagnosis,
* With no physical deformities or functional impairments caused by comorbid conditions or treatments (e.g., lymphedema, hemiparesis, amputation, tracheostomy),
* Capable of communication, no cognitive impairments or diagnosed psychiatric disorders,
* Having completed chemotherapy and/or radiotherapy,
* With no prior counseling or education related to body image or sexual quality of life.

Exclusion Criteria:

* Women who were not between the ages of 18 and 60,
* Not married and/or without a partner,
* Not residing in the city where the study was conducted,
* Not informed about their diagnosis,
* With physical deformities or functional impairments caused by comorbid conditions or treatments (e.g., lymphedema, hemiparesis, amputation, tracheostomy),
* Unable to communicate, with cognitive impairments or diagnosed psychiatric disorders,
* Still undergoing chemotherapy and/or radiotherapy,
* Had previously received any counseling or education related to body image or sexual quality of life.

Primary outcomes:
measure: Breast Cancer Body Image Scale (BCBIS)
timeFrame: 12 weeks
measure: Female Sexual Life Quality Scale (SQoL-F)
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Diyarbakır
country: Turkey
facility: Dicle University Hospital, Diyarbakır, Turkey
Study officials:
affiliation: Department of Surgical Nursing, Faculty of Nursing, İnönü University
name: Meral Özkan, Prof.
role: STUDY_DIRECTOR
References: