Effects of Expectations and Body Image in Breast Reconstruction

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Implant-based breast reconstruction; Procedure: Autologous breast reconstruction; Procedure: Combined methods

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Emma Hansson, PhD; Phone Number: +46313421000; Email: emma.em.hansson@vgregion.se

Study Locations

• Sweden
  • Gothenburg, Sweden, 413 45
    • Recruiting
    • Sahlgrenska University Hospital
    • Contact: Linn Weick, MA; Phone Number: +46 31 342 10 00; Email: linn.weick@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Biological women with breast cancer or high risk for breast cancer who want immediate or delayed post-mastectomy breast reconstruction.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Translation and validation of Breast-Q expectations	Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.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.	4 months
Translation and validation of Appearance schemas inventory-revised (ASI-R)	Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population. ASI-Ris 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.	4 months
Translation and validation of Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)	Translation into Swedish according to MAPI-guidelines. Validation of psychometric properties in a Swedish population.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.	4 months

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region
• Investigators: Principal Investigator: Emma Hansson, PhD, Göteborg University

Publications and helpful links

General Publications

• Weick L, Grimby-Ekman A, Lunde C, Hansson E. Validation and reliability testing of the BREAST-Q expectations questionnaire in Swedish. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):315-323. doi: 10.1080/2000656X.2022.2070180. Epub 2022 May 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 14, 2021
• First Posted (Actual): January 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: breast reconstruction; complication; plastic surgery; expectations; body image
• Other Study ID Numbers: 2020-06245

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No