Effects of Expectations and Body Image in Breast Reconstruction

Study Overview
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Brief Summary
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A breast reconstruction after mastectomy, either due to breast cancer or a high lifetime risk for cancer, is performed to increase the patient's quality of life. However, there are studies that show that some women regret their decision to have breast reconstruction. There are also studies demonstrating similarities in the general patterns of psychosocial adjustment and quality of life among women with breast cancer who have undergone breast-conserving surgery, mastectomy alone, and mastectomy combined with breast reconstruction. Hence, it is unclear which women actually beneﬁt from a breast reconstruction. The concept of quality of life is connected to patient satisfaction and body image/investment. Therefore, the aim of this project is to examine the effects of patient expectations and body image on the patient reported outcomes of breast reconstruction, to improve preoperative information and postoperative care for women considering a breast reconstruction.

Official Title
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Psychological Effect of Expectations and Body Image on Outcomes of Breast Reconstruction

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Implant-based breast reconstruction
* Procedure: Autologous breast reconstruction
* Procedure: Combined methods


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction Age > 18 years Exclusion Criteria: Inability to give informed consent Inability to understand Swedish Relaps of cancer Palliative treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Immediate breast reconstruction<br>Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer | Procedure: Implant-based breast reconstruction<br>* All types of implant based breast reconstructions<br>Procedure: Autologous breast reconstruction<br>* All types of autologous breast reconstructions<br>Procedure: Combined methods<br>* All types of breast reconstructions combining autologous and implant based techniques<br>|
| Delayed breast reconstruction<br>Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer | Procedure: Implant-based breast reconstruction<br>* All types of implant based breast reconstructions<br>Procedure: Autologous breast reconstruction<br>* All types of autologous breast reconstructions<br>Procedure: Combined methods<br>* All types of breast reconstructions combining autologous and implant based techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction with breast reconstruction measured with Breast Q reconstruction | Breast Q reconstruction includes two domains and six different modules: health-related quality of life (HR-QOL; including physical, psychosocial, and sexual well-being) and patient satisfaction (including satisfaction with breasts, outcome, and care). Each scale produces an independent score from 0-100. A higher score means greater satisfaction or better QOL. | 2 years | 
| Patient expectations measured with Breast Q expectations | Breast Q expectations.The scale consists of five modules: expectations for support from medical staff , expectations for pain, expectations for coping, expectations for breast appearance when clothed and expectations for breast sensation. The score for each independent scale range from 0-100. A higher score means greater expectations. | 2 years | 
| Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS) | MBSRQ-AS - Multidimensional body-self relations questionnaire- appearance scales.It is a 34-item self-report questionnaire designed to measure appearance related components of body-image. In consists of five subscales: appearance evaluation, appearance orientation, body areas satisfaction, overweight preoccupation, and self-classified weight. It is a 5-point Likert-scale ranging from 1 to 5. | 2 years | 
| Body image investment measured with Appearance schemas inventory-revised (ASI-R) | ASI-R - Appearance schemas inventory-revised: is a 20-item self-report questionnaire designed to measure body-image investment. It consists of two subscales, self-evaluative salience (SES) and motivational salience (MS). It is a 5-point Likert-scale ranging from 1 (strongly disagree) to 5 (strongly agree). Twelve items relate to SES and eight items relate to MS. The total score is the mean of the 20 items, and the score of the subscales is the mean of the items relating to each subscale. A high score indicates greater body-image investment. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with preoperative information measured with Breast Q reconstruction | Measured with one of the sub scales of Breast Q reconstruction | 2 years | 
| Pain measured with a visual analogue scale | Measured with a post-operative pain dairy with VAS scales (o means no pain and 10 means the worst possible pain imaginable) | 2 weeks | 
| Sick leave according to authorities | Actual sick leave according to the Swedish authorities | 1 year | 
| Number of out-patient visits according to the medical charts | Actual number of out-patient visits, according to the medical chart | 1 year | 
| Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS) | HADS - Hospital Anxiety and Depression Scale: is a 14-item self-report questionnaire that is designed to measure anxiety and depression. It has two domains, where seven items relate to anxiety and seven relate to depression. It is a 4-point Likert-scale ranging from 0-3. Each domain has a maximum score of 21. For both domains, scores of less than 7 indicate non-cases, whereas scores of 8-10 indicate mild anxiety or depression, 11-14 moderate and 15-21 severe. | 2 years | 
| Demographic factors and medical factors according to medical charts | Demographic factors that might affect expectations and satisfaction, such as age, comorbidity, and previous cosmetic breast surgery, and medical factors such as timing of reconstructions, reason for mastectomy, type of cancer and cancer treatment received. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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plastic surgery, breast reconstruction, complication, expectations, body image