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Effects of Expectations and Body Image in Breast Reconstruction

NCT ID: NCT04714463

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-01

Study Completion Date

2026-12-31

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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Immediate breast reconstruction

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

Implant-based breast reconstruction

Intervention Type PROCEDURE

All types of implant based breast reconstructions

Autologous breast reconstruction

Intervention Type PROCEDURE

All types of autologous breast reconstructions

Combined methods

Intervention Type PROCEDURE

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

Implant-based breast reconstruction

Intervention Type PROCEDURE

All types of implant based breast reconstructions

Autologous breast reconstruction

Intervention Type PROCEDURE

All types of autologous breast reconstructions

Combined methods

Intervention Type PROCEDURE

All types of breast reconstructions combining autologous and implant based techniques

Interventions

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Implant-based breast reconstruction

All types of implant based breast reconstructions

Intervention Type PROCEDURE

Autologous breast reconstruction

All types of autologous breast reconstructions

Intervention Type PROCEDURE

Combined methods

All types of breast reconstructions combining autologous and implant based techniques

Intervention Type PROCEDURE

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emma Hansson, PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

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Sahlgrenska university hospital

Gothenburg, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Emma Hansson, PhD

Role: CONTACT

[email protected]
+46313421000

Facility Contacts

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Linn Weick, MA

Role: primary

[email protected]
+46 31 342 10 00

References

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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.

Reference Type DERIVED
PMID: 41139858 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35533094 (View on PubMed)

Other Identifiers

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2020-06245

Identifier Type: -

Identifier Source: org_study_id

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