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

Development of Decision Support for Couples with Hereditary Cancer and Child Wish

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON22355

Enrollment

256

Registered

2015-10-21

Start date

2017-02-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hereditary cancer, child wish, decision making, risk communication, prenatal diagnosis, preimplantation genetic diagnosis

Interventions

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 g

Eligibility

Inclusion criteria

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

Exclusion criteria: - insufficient knowledge of the Dutch language - pregnancy at time of inclusion

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Secondary 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.	—

Measure

Time frame

Secondary 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.

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Contacts

Public ContactKelly Reumkens

Department of Clinical Genetics - Maastricht UMC+

kelly.reumkens@mumc.nl+31(0)43-3874165

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)