The Signal-Trial: Evaluation of a screening tool for psychosocial problems in cancer genetics.
Recruiting
- Conditions
- Cancer geneticsPsychosocial problemsOnco-geneticaPsychosociale problemen
- Registration Number
- NL-OMON21151
- Lead Sponsor
- etherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL), University Medical Center Utrecht (UMCU)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 260
Inclusion Criteria
1. Between 18 and 70 years of age;
2. Sufficient command of the Dutch language to complete questionnaires;
Exclusion Criteria
Those who do not fulfill the inclusion criteria.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Increased communication on psychosocial issues, measured using an audiotape of the counseling session and telephone follow-up;<br /><br>2. Counselors awareness of psychosocial problems of the counselee, measured using a checklist being completed by the counselor after the counseling session and the telephone follow-up;<br /><br>3. Management of the psychosocial problems of the counselee, measured using an audiotape of the counseling session and telephone follow-up.
- Secondary Outcome Measures
Name Time Method 1. Number of initiations of discussed problems, measured using an audiotape of the counseling session and telephone follow-up;<br /><br>2. Time spent on psychosocial problems, measured using an audiotape of the counseling session and telephone follow-up;<br /><br>3. Satisfaction of counselor and counselee, measured using self-developed questions. Measured within the questionnaire after the counseling session and the telephone follow-up;<br /><br>4. Levels of cancer worries of the counselee, assessed using the Cancer Worry Scale. Measured using the questionnaire at baseline, after the counseling session and after the telephone follow-up;<br /><br>5. Number of psychosocial problems, assessed using the Signal-checklist. Measured at the intervention timepoints, and is part of the questionnaire after the telephone follow-up;<br /><br>6. Feasability of implementing a questionnaire, assessed using self-developed questions within the questionnaire after the telephone follow-up.