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Completed

NCT Number: NCT06981910

The Role of Psychoeducation in Breast Cancer Care

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.

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Key information

Conditions

Psychoeducation for Patients Who Have Undergone Mastectomy Breast Diseases Breast Neoplasms Mastectomy Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Dicle University Hospital, Diyarbakır, Turkey

Diyarbakır, 21080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Breast Cancer Body Image Scale (BCBIS)

    Time frame: 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.

  2. Female Sexual Life Quality Scale (SQoL-F)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dicle University

Other

Registry information

Official study title

The Effect of Psychoeducation on Body Image and Sexual Quality of Life in Patients Undergoing Mastectomy

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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