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A study of Outcome, Quality of Life and Satisfaction in women after breast reconstruction.


- candidate number13153
- NTR NumberNTR3534
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2012
- Secondary IDsNL32863.042.10 ABR
- Public TitleA study of Outcome, Quality of Life and Satisfaction in women after breast reconstruction.
- Scientific TitleA study of Outcome, Quality of Life and Satisfaction in women after breast reconstruction.
- ACRONYM
- hypothesisWe expect that from 6 weeks on after a breast reconstruction with autologous material, quality of life is higher than after reconstruction with implants.
- Healt Condition(s) or Problem(s) studiedBreast cancer, Breast reconstruction, BRCA1/2, Preventive mastectomy, Alloplastic reconstruction, Autologous reconstruction
- Inclusion criteria1. 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;
3. Young women with breast cancer who need preventive mastectomy of the other breast and want their breast reconstructed;
4. Informed consent.
- Exclusion criteria1. Women who do not understand the Dutch language well;
2. Women who are illiterate in reading and/or writing;
3. Women below 18 years of age;
4. Women who are legally incompetent;
5. Women who have a bad prognosis. (terminally ill, patients with metastases);
6. Drug abuse.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-aug-2012
- planned closingdate1-aug-2020
- Target number of participants116
- InterventionsFor this study the main source for data are patient reported data, resulting from questionnairs.
- Primary outcomeThe primary outcome measure is the Quality of Life as measured with the Breast Q.
- Secondary outcome1. Health related Quality of Life as measured by the Rand 36;
2. The fear for recurrence of cancer on the QoL of the breast cancer patients as measured by the CARS;
3. Anxiety and Depression as measured by the HADS;
4. Cosmetic outcome as measured by the Strasser Score and the POSAS.
- TimepointsThe participants will fill in QoL questionnaires pre-operative and then at 6 weeks, 6 months, 1 year and 3 years post reconstruction.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIES M. Dreise
- CONTACT for SCIENTIFIC QUERIES I.S. Krabbe
- Sponsor/Initiator University Medical Center Groningen (UMCG)
- Funding
(Source(s) of Monetary or Material Support)
University Medical Center Groningen (UMCG)
- PublicationsN/A
- Brief summaryObjective:
To systematically research the experiences concerning psychosocial impact and quality of life and their medical outcome of women who undergo different types of reconstruction. The results of this study may help to improve our insight into the effects of our work. With this knowledge we expect to be able to further improve the care for those patients. More specifically, this research aims to provide women who consider breast reconstruction with better counselling and help women make the best decision for an optimal treatment.
- Main changes (audit trail)
- RECORD18-jul-2012 - 5-aug-2012


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