The Role of Psychoeducation in Breast Cancer Care

Not Applicable

Completed

• Conditions: Psychoeducation for Patients Who Have Undergone Mastectomy; Mastectomy

• Registration Number: NCT06981910
• Lead Sponsor: Dicle University

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.

Study Timeline

• Study Start: 2023-10-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-05
• Study First Submitted: 2025-05-10
• Study First Submitted QC: 2025-05-17
• Last Update Submitted: 2025-05-17
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Breast Cancer Body Image Scale (BCBIS)	12 weeks	The scale comprises 43 items (32 positively worded and 11 negatively worded) divided into two sections. Section 1 uses a five-point Likert scale: "Strongly disagree" (1), "Disagree" (2), "Neutral" (3), "Agree" (4), and "Strongly agree" (5). Section 2 also employs a five-point Likert scale: "Never" (1), "Rarely" (2), "Sometimes" (3), "Usually" (4), and "Always" (5). Negatively worded items are reverse-scored. The total score ranges between 43 and 215, and there is no established cutoff point; higher scores indicate a higher level of body image disturbance. The scale consists of six subdimensions. The Cronbach's α for the overall scale was reported to be 0.67.
Female Sexual Life Quality Scale (SQoL-F)	12 weeks	This 18-item scale has a six-point Likert format and was designed to be self-administered by women aged 18 and older. Participants are instructed to respond based on their sexual experiences during the past four weeks. Items are scored as follows: "Completely agree" (1), "Mostly agree" (2), "Somewhat agree" (3), "Somewhat disagree" (4), "Mostly disagree" (5), and "Completely disagree" (6). Before computing the total score (ranging from 18 to 108), responses to items 1, 5, 9, 13, and 18 are reverse-scored. The final score is converted to a scale out of 100, and a higher score indicates better sexual quality of life. The Cronbach's α for the overall scale is 0.83.

Trial Locations

Locations (1)

Dicle University Hospital, Diyarbakır, Turkey; 🇹🇷 Diyarbakır, Turkey