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van CCT (UK)

van CCT (UK)

Decision-support for couples with hereditary cancer and child wish: weighing pros and cons of reproductive options regarding transmission of gene mutations.

- candidate number22994
- NTR NumberNTR5467
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-okt-2015
- Secondary IDsUM2013-6374 Alpe d’HuZes
- Public TitleDecision-support for couples with hereditary cancer and child wish: weighing pros and cons of reproductive options regarding transmission of gene mutations.
- Scientific TitleDevelopment of Decision Support for Couples with Hereditary Cancer and Child Wish
- hypothesisThis 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.
- Healt Condition(s) or Problem(s) studiedGenetic counseling, Cancer and genetics
- Inclusion criteria- 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
- Exclusion criteria- insufficient knowledge of the Dutch language

- pregnancy at time of inclusion
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blinding[default]
- controlNot applicable
- group[default]
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2017
- planned closingdate1-sep-2018
- Target number of participants256
- InterventionsA 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.
- Primary outcomeLevels 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.
- Secondary outcomeSecondary outcomes include knowledge of different reproductive options, accuracy of perceived risks, satisfaction with the decision and the decision making process (e.g., Satisfaction with Decision Scale; Holmes-Rovner et al., 1996), and decision self-efficacy (Decision Self-efficacy Scale; Bunn & O¡¯Connor, 1996). The Multidimensional Measure of Informed Choice (MMIC; Marteau et al., 2001) will be used to assess informed choice. It should be noted that using the MMIC, an informed choice is based on relevant knowledge, is consistent with a person¡¯s values and is behaviourally implemented. As behavioural implementation or adherence to the decision (i.e. uptake of the test or treatment) is unlikely to have occurred for many couples during the study period, only subscales will be used for full analysis. Furthermore, acceptability of the brochures and DA will be assessed by recording whether women used the resource, the time taken to use the resource and how helpful they thought the resource was. For the DA, objective recordings of DA use will be available.
- Timepoints01-02-2017 untill 01-09-2018
- Trial web site
- statusplanned
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Alpe d’HuZes Foundation
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD21-okt-2015 - 23-dec-2015

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