This project will deliver a user-centred evidence-based patient decision aid, supporting couples with hereditary cancer in their decision making regarding fulfilment of their child wish. The decision aid will facilitate couples with an hereditary…
ID
Bron
Verkorte titel
Aandoening
Hereditary cancer, child wish, decision making, risk communication, prenatal diagnosis, preimplantation genetic diagnosis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Levels of decisional conflict will be assessed by means of the Decisional Conflict Scale (DCS; O¡¯Connor, 1995). The DCS contains 16 items divided into three subscales, measuring uncertainty about selection of alternatives, specific factors contributing to uncertainty, and perceived effectiveness of decision making.
Doel van het onderzoek
This project will deliver a user-centred evidence-based patient decision aid, supporting couples with hereditary cancer in their decision making regarding fulfilment of their child wish. The decision aid will facilitate couples with an hereditary elevated cancer risk and an active child wish in choosing the most personally suitable reproductive option. As a result, we aim to relieve the exceptional psychological burden regarding reproductive decision making in affected families.
Onderzoeksopzet
01-02-2017 untill 01-09-2018
Onderzoeksproduct en/of interventie
A multi-centre randomized controlled trial will be implemented to investigate the efficacy of the DA. Couples will be randomly allocated to a control group (standard information) and an experimental group (DA). Randomization will take place at the couple level by means of separate randomization schedules for each of the nine participating genetic centres. All randomization schedules will be created using a computer random number generator.
Publiek
Kelly Reumkens
Bezoekadres: P. Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31(0)43-3874165
kelly.reumkens@mumc.nl
Wetenschappelijk
Kelly Reumkens
Bezoekadres: P. Debyelaan 25
Maastricht 6229 HX
The Netherlands
+31(0)43-3874165
kelly.reumkens@mumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Confirmed genetic mutation for a hereditary cancer syndrome for which PND and PGD are available in the Netherlands. This includes, but is not limited to, the following types of hereditary cancer:
o Hereditary breast and ovarian cancer (HBOC)
o Hereditary colon cancer, e.g. Familial Adenomatous Polyposis (FAP), Hereditary Non-Polyposis Colorectal Cancer (HNPCC/Lynch Syndrome)
o Peutz-Jeghers Syndrome
o Multiple endocrine neoplasia (MEN1/2)
o Retinoblastoma
o Von Hippel Lindau disease
o Li-Fraumeni Syndrome
o Familial Atypical Multiple Mole/Melanoma Syndrome (FAMMM)
- woman in reproductive age (18-40 years)
- active child wish (¡Ü 2 years)
- access to the Internet
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- insufficient knowledge of the Dutch language
- pregnancy at time of inclusion
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5357 |
| NTR-old | NTR5467 |
| Ander register | Alpe d’HuZes : UM2013-6374 |