We expect that from 6 weeks on after a breast reconstruction with autologous material, quality of life is higher than after reconstruction with implants.
ID
Bron
Aandoening
Breast cancer, (preventive) mastectomy, BRCA gene mutation, Breast reconstruction, autologous reconstruction, alloplastic reconstruction.
Borstreconstructie, (preventieve) ablatio, , BRCA gen mutatie, autologe reconstructie, alloplastische reconstructie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is the Quality of Life as measured with the Breast Q.
Achtergrond van het onderzoek
Objective:
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.
Doel van het onderzoek
We expect that from 6 weeks on after a breast reconstruction with autologous material, quality of life is higher than after reconstruction with implants.
Onderzoeksopzet
The participants will fill in QoL questionnaires pre-operative and then at 6 weeks, 6 months, 1 year and 3 years post reconstruction.
Onderzoeksproduct en/of interventie
For this study the main source for data are patient reported data, resulting from questionnairs.
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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;
3. Young women with breast cancer who need preventive mastectomy of the other breast and want their breast reconstructed;
4. Informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3392 |
| NTR-old | NTR3534 |
| CCMO | NL32863.042.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38410 |