Psychological Effects of Implant Loss

NCT04503018 | Completed

• 1 other identifier: 2019-06214
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Previous quality of life studies have suggested that long term satisfaction with breast reconstruction may be affected by postoperative complications. Complication frequencies, especially the risk for implant loss, is considerably higher in immediate than in delayed breast reconstruction. Knowledge about how implant loss affects the patient's experience of her breast reconstruction can guide us in the choice between immediate and delayed breast reconstruction in high risk patients and help us better prepare the patients for possible complications. This study will investigate patients' experiences with losing an implant in connection with immediate breast reconstruction.

Conditions

Breast Cancer Female

Keywords

Breast reconstruction; Plastic surgery; Psychology

Outcome Measures

Primary Outcomes (6)

• Experiences and psychological effects of implant loss after immediate breast reconstruction

  Interviews

  10 years

• Effect on quality of life of implant loss: scale

  Breast-Q reconstruction post-operative. It includes different domains: 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

  10 years

• Effect on body image of implant loss

  Body-Esteem Scale for Adolescents and Adults (BESAA). It consists of three subscales: BE-appearance, BE-weight and BE-attribution.The scale has 23 items and the respondents indicated their degree of agreement on a 5-point Likert scale ranging from 0 (never) to 4 (always).High score indicates higher dimensions of the Body Esteem.

  10 years

• Effect on depression and anxiety of implant loss

  Hospital Anxiety and Depression scale (HAD).The HADS is a fourteen item scale that generates: Seven of the items relate to anxiety and seven relate to depression.For both scales, scores of less than 7 indicate non-cases. 8-10 mild, 11-14 moderate, 15-21 severe.

  10 years

• Coping strategies

  Brief-cope, a 28 item self-report questionnaire designed to measure effective and ineffective ways to cope with a stressful life event.Scores are presented for the two overarching coping styles: avoidant and approach.The scale can determine someone's primary coping styles.

  10 years

• Coping strategies

  The Life orientation test - revised (Lot-R) is a 10-item scale that measures how optimistic or pessimistic people feel about the future. High values imply optimism.

  10 years

Study Arms (3)

Interviewed -implant loss

Patients who have had immediate breast reconstruction and lost the implant due to for example infection.

Questionnaires - implant loss

Patients who have had immediate breast reconstruction and lost the implant due to for example infection.

Questionnaires - controls

Patients who have had immediate breast reconstruction without complications

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Purposive criterion sampling technique is used. The population will identified through an operation planning software

You may qualify if:

• Biological women
• Age \>18 years
• Have lost an implant after a mastectomy and immediate breast reconstruction

You may not qualify if:

• Inability to give informed consent
• inability to speak and understand Swedish
• relapse of breast cancer after the reconstruction
• metastatic disease
• psychiatric co-morbidity.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Västra Götaland

Gothenburg, 413 45, Sweden

Location

Related Publications (2)

• Weick L, Ericson A, Sandman L, Bostrom P, Hansson E. Patient experience of implant loss after immediate breast reconstruction: An interpretative phenomenological analysis. Health Care Women Int. 2023 Jan;44(1):61-79. doi: 10.1080/07399332.2021.1944152. Epub 2021 Aug 24.

  PMID: 34427538 RESULT

• Weick L, Lunde C, Hansson E. The effect of implant loss after immediate breast reconstruction on patient satisfaction with outcome and quality of life after five years - a case-control study. J Plast Surg Hand Surg. 2023 Feb-Dec;57(1-6):263-270. doi: 10.1080/2000656X.2022.2061501. Epub 2022 Apr 15.

  PMID: 35427208 RESULT

Related Links

• Full text article

Study Officials

• Emma Hansson, PhD

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 6, 2020
• Study Start: March 1, 2020
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

SE (1)