Psychological Effects of Implant Loss

Breast Cancer Female Clinical Trial

Official title:

Psychological Effects of Implant Loss

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04503018
• Other study ID #: 2019-06214
• Status: Recruiting
• Start date: March 1, 2020
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2023
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biological women

• Age >18 years

• Have lost an implant after a mastectomy and immediate breast reconstruction

Exclusion Criteria:

• Inability to give informed consent

• inability to speak and understand Swedish

• relapse of breast cancer after the reconstruction

• metastatic disease

• psychiatric co-morbidity.

Related Conditions & MeSH terms

• Breast Cancer Female

Locations

Country	Name	City	State
Sweden	Västra Götaland	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Vastra Gotaland Region

Country where clinical trial is conducted

Sweden, 

References & 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. Ep — View Citation

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: 10.1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Experiences and psychological effects of implant loss after immediate breast reconstruction	Interviews	10 years
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

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