The Role of Psychoeducation in Breast Cancer Care

NCT06981910 | Completed DMC

• 1 other identifier: DicleU-ASBF-NURSE-ÇS-02
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychoeducation for Patients Who Have Undergone Mastectomy; Mastectomy

Keywords

Breast cancer; Mastectomy; Psychoeducation; Body image; Sexual quality of life

Outcome Measures

Primary Outcomes (2)

• Breast Cancer Body Image Scale (BCBIS)

  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.

  12 weeks

• Female Sexual Life Quality Scale (SQoL-F)

  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.

  12 weeks

Study Arms (2)

Psychoeducation

EXPERIMENTAL

A semi-structured "Psychoeducation Program" was implemented over six weeks, with 90-minute sessions conducted weekly. Each subgroup received psychoeducation on different days within the same week. The week the psychoeducation concluded was designated as Week 0, and the scales were re-administered in Week 4.

Behavioral: Psychoeducation program

Control

NO INTERVENTION

No intervention was provided to the control group; the same scales were administered to them during the 4th week after the conclusion of the psychoeducation program in the psychoeducation group

Interventions

Psychoeducation program BEHAVIORAL

Each psychoeducation session included informational components, a preliminary group discussion of the topic, structured education on the discussed topic, awareness-raising activities within the group, opportunities for sharing, and emotional support. When participants' attention waned during sessions, breathing exercises were introduced. Depending on the group's preference, sessions concluded with a 2-3-minute poetry listening session and/or breathing exercises. At the end of each session, educational booklets prepared specifically for that session were distributed to the participants.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dicle University: lead

Study Sites (1)

Dicle University Hospital, Diyarbakır, Turkey

Diyarbakır, 21080, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Meral Özkan, Prof.

  Department of Surgical Nursing, Faculty of Nursing, İnönü University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: This study was carried out as a two-group, parallel, randomized controlled trial

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 21, 2025
• Study Start: October 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)