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The Signal - Trial: evaluation of a screening tool for psychosocial problems in cancer genetics

The Signal - Trial: evaluation of a screening tool for psychosocial problems in cancer genetics - The Signal - Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON35886
Enrollment
200
Registered
2011-08-29
Start date
2011-10-15
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

psychische problemen bij erfelijkheidsonderzoek voor kanker Psychosocial problems

Interventions

The intervention will take place twice: during genetic counseling (usually the 3rd contact with the clinic), and at follow-up (four weeks after the disclosure of the test result). The intervention c

Sponsors

Nederlands Kanker Instituut
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1) between 18 and 70 years of age 2) in sufficient command of the Dutch language to complete the questionnaires 3) attendees of a second visit at the family cancer clinic because of increased risk of developing cancer due to hereditary predisposition

Exclusion criteria

Exclusion criteria: Those who do not fulfill the inclusion criteria

Design outcomes

Primary

MeasureTime frame
The primary outcomes of the trial are: 1) increased communication on psychosocial issues, 2) counselors awareness of psychosocial problems of the counselee, and 3) management of these psychosocial problems of the counselee during and after the process of genetic counselling.

Secondary

MeasureTime frame
The secondary outcomes of the trial are: 1) the number of initiations of discussed problems by counselor or counselee, 2) time spent on psychosocial problems, 3) counselee and counselor*s level of satisfaction, 4) levels of counselee cancer worries, 5) number of psychosocial problems, and 6) counselee and counselor evaluation of the intervention/ feasibility of the implementation of the intervention.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)