A study of Outcome, Quality of Life and Satisfaction in women after breast reconstruction.
- Conditions
- Breast cancer, (preventive) mastectomy, BRCA gene mutation, Breast reconstruction, autologous reconstruction, alloplastic reconstruction.Borstreconstructie, (preventieve) ablatio, , BRCA gen mutatie, autologe reconstructie, alloplastische reconstructie
- Registration Number
- NL-OMON22225
- Lead Sponsor
- niverity Medical Centre Groningen
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 116
Inclusion Criteria
1. Women who have/had breast cancer and need(ed) a mastectomy and will undergo a breast reconstruction;
2. Women with BRCA gene mutation, who undergo a preventive mastectomy and want their breasts primarily reconstructed;
Exclusion Criteria
1. Women who do not understand the Dutch language well;
2. Women who are illiterate in reading and/or writing;
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome measure is the Quality of Life as measured with the Breast Q.
- Secondary Outcome Measures
Name Time Method 1. Health related Quality of Life as measured by the Rand 36;<br /><br>2. The fear for recurrence of cancer on the QoL of the breast cancer patients as measured by the CARS;<br /><br>3. Anxiety and Depression as measured by the HADS;<br /><br>4. Cosmetic outcome as measured by the Strasser Score and the POSAS.