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Recruiting NCT04714463

Effects of Expectations and Body Image in Breast Reconstruction

— Observational Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Implant-based breast reconstruction, Autologous breast reconstruction, Combined methods.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Patient satisfaction with breast reconstruction measured with Breast Q reconstruction [Time frame: 2 years]
  • Patient expectations measured with Breast Q expectations [Time frame: 2 years]
  • Body image measured with Multidimensional body-self relations questionnaire- appearance scales (MBSRQ-AS) [Time frame: 2 years]
  • Body image investment measured with Appearance schemas inventory-revised (ASI-R) [Time frame: 2 years]
Secondary outcome measures (6)
  • Satisfaction with preoperative information measured with Breast Q reconstruction [Time frame: 2 years]
  • Pain measured with a visual analogue scale [Time frame: 2 weeks]
  • Sick leave according to authorities [Time frame: 1 year]
  • Number of out-patient visits according to the medical charts [Time frame: 1 year]
  • Depression and anxiety measured with Hospital Anxiety and Depression Scale (HADS) [Time frame: 2 years]
  • Demographic factors and medical factors according to medical charts [Time frame: 2 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Sahlgrenska university hospital — Gothenburg

Publications

  • Jepsen C, Paganini A, Hansson E. Validation and reliability testing of the Swedish version of the BREAST-Q reconstruction. Scand J Surg. 2026 Mar;115(1):88-96. doi: 10.1177/14574969251387498. Epub 2025 Oct 26. PMID 41139858
  • 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

Identifiers

NCT: NCT04714463 · 2020-06245

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗