Psychological Effects of Implant Loss

Recruiting

• Conditions: Breast Cancer Female

• Registration Number: NCT04503018
• Lead Sponsor: Vastra Gotaland Region

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-01
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-21
• Last Update Posted: 2023-12-22
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Experiences and psychological effects of implant loss after immediate breast reconstruction	10 years	Interviews
Effect on quality of life of implant loss: scale	10 years	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
Effect on body image of implant loss	10 years	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.
Effect on depression and anxiety of implant loss	10 years	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.
Coping strategies	10 years	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.

Trial Locations

Locations (1)

Västra Götaland; 🇸🇪 Gothenburg, Sweden