No registrations found.
ID
Source
Health condition
Breast cancer, (preventive) mastectomy, BRCA gene mutation, Breast reconstruction, autologous reconstruction, alloplastic reconstruction.
Borstreconstructie, (preventieve) ablatio, , BRCA gen mutatie, autologe reconstructie, alloplastische reconstructie
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the Quality of Life as measured with the Breast Q.
Secondary outcome
1. 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.
Background summary
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.
Study objective
We expect that from 6 weeks on after a breast reconstruction with autologous material, quality of life is higher than after reconstruction with implants.
Study design
The participants will fill in QoL questionnaires pre-operative and then at 6 weeks, 6 months, 1 year and 3 years post reconstruction.
Intervention
For this study the main source for data are patient reported data, resulting from questionnairs.
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;
3. Young women with breast cancer who need preventive mastectomy of the other breast and want their breast reconstructed;
4. Informed consent.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3392 |
| NTR-old | NTR3534 |
| CCMO | NL32863.042.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON38410 |