Effects of Expectations and Body Image in Breast Reconstruction

NCT04714463 | Recruiting

• 1 other identifier: 2020-06245
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

plastic surgery; breast reconstruction; complication; expectations; body image

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Satisfaction with preoperative information measured with Breast Q reconstruction

  2 years

• Pain measured with a visual analogue scale

  2 weeks

• Sick leave according to authorities

  1 year

• Number of out-patient visits according to the medical charts

  1 year

• Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS)

  2 years

Other Outcomes (3)

• Translation and validation of Breast-Q expectations

  4 months

• Translation and validation of Appearance schemas inventory-revised (ASI-R)

  4 months

• Translation and validation of Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS)

  4 months

Study Arms (2)

Immediate breast reconstruction

Women undergoing immediate breast reconstruction due to breast cancer or a high risk for breast cancer

Procedure: Implant-based breast reconstruction; Procedure: Autologous breast reconstruction; Procedure: Combined methods

Delayed breast reconstruction

Women undergoing delayed breast reconstruction due to breast cancer or a high risk for breast cancer

Procedure: Implant-based breast reconstruction; Procedure: Autologous breast reconstruction; Procedure: Combined methods

Interventions

Implant-based breast reconstruction PROCEDURE

All types of implant based breast reconstructions

Delayed breast reconstruction; Immediate breast reconstruction

Autologous breast reconstruction PROCEDURE

All types of autologous breast reconstructions

Delayed breast reconstruction; Immediate breast reconstruction

Combined methods PROCEDURE

All types of breast reconstructions combining autologous and implant based techniques

Delayed breast reconstruction; Immediate breast reconstruction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Biological women with breast cancer or high risk for breast cancer who want post-mastectomy breast reconstruction
• Age \> 18 years

You may not qualify if:

• Inability to give informed consent
• Inability to understand Swedish
• Relaps of cancer
• Palliative treatment

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Sahlgrenska university hospital

Gothenburg, 413 45, Sweden

RECRUITING

Related Publications (2)

• Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2025 Oct 26:14574969251387498. doi: 10.1177/14574969251387498. Online ahead of print.

  PMID: 41139858 DERIVED

• 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.

  PMID: 35533094 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Emma Hansson, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Hansson, PhD

CONTACT

+46313421000; emma.em.hansson@vgregion.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 19, 2021
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)