Psychoeducation for Patients Who Have Undergone MastectomyNCT06981910
The Role of Psychoeducation in Breast Cancer Care
A study testing Psychoeducation program in people with Psychoeducation for Patients Who Have Undergone Mastectomy and Mastectomy, run by Dicle University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Psychoeducation for Patients Who Have Undergone Mastectomy, Mastectomy
- What is being tested?
- Psychoeducation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Oct 2023to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dicle University Hospital, Diyarbakır, Turkey
Diyarbakır, 21080
About this study
Official title: The Effect of Psychoeducation on Body Image and Sexual Quality of Life in Patients Undergoing Mastectomy
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.
Read the 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.
- Being tested
- Psychoeducation program
- Keywords
- Breast cancer, Mastectomy, Psychoeducation, Body image, Sexual quality of life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Oct 2023
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychoeducation for Patients Who Have Undergone MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was carried out as a two-group, parallel, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çiçek SARUHAN, Dicle University
- Investigators
- Meral Özkan, Prof., Study director, Department of Surgical Nursing, Faculty of Nursing, İnönü University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06981910
- Sponsor's protocol ID
- DicleU-ASBF-NURSE-ÇS-02
- Status last verified
- May 2025
- First submitted
- 10 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Psychoeducation on Body Image and Sexual Quality of Life in Patients Undergoing Mastectomy
- ClinicalTrials.gov ID
- NCT06981910
- Acronym / sponsor ID
- DicleU-ASBF-NURSE-ÇS-02
- Keywords
- Breast cancer, Mastectomy, Psychoeducation, Body image, Sexual quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was carried out as a two-group, parallel, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Psychoeducation | Experimental | Behavioral: Psychoeducation programA 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. |
| 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation programEach 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. | Behavioural | Psychoeducation |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meral Özkan, Prof. study director
Department of Surgical Nursing, Faculty of Nursing, İnönü University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation program in people with Psychoeducation for Patients Who Have Undergone Mastectomy and Mastectomy, run by Dicle University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Cancer Body Image Scale (BCBIS) (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.