Study of the possible factors of influence on the decision to partipate in early clinical cancer trials.
Completed
- Conditions
- Patients with solid tumors without standard treatment options considering participation in a phase I or phase II trial
- Registration Number
- NL-OMON20050
- Lead Sponsor
- ErasmusMC, Rotterdam, The Netherlands
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Patients considering participation on a phase I or phase II trial for the first time.
Exclusion Criteria
1. Prior participation in phase I or II trial;
2. Age under 18 years.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Outcome: <br /><br>The influence of ‘motivation for treatment, hope, coping, locus of control and quality of life’ on the decision whether or not to participate in a phase I or phase II cancer trial.<br /><br>Outcome Name: <br /><br>Participation or non participation in a phase I or II cancer trial, motivation for treatment, hope, coping, locus of control and quality of life’.<br /><br>The influence of ‘motivation for treatment, hope, coping, locus of control and quality of life’ will be measured using a questionair on different timepoint. The questionnaire contains 5 subquestionnaires: <br /><br>1. Validated 12 items motivation questionnaire by Prochaska en DiClemente;<br /><br>2. Validated 30 items coping questionnaire by Brandtstadter and Renner;<br /><br>3. Validated 19 item questionnaire by of the Rotter locus of controle scale;<br /><br>4. Validates 12 items questionnaire of the Herth Hope Index;<br /><br>5. Quality of life is measured with the EORTC QLQ-C30, 3.0.
- Secondary Outcome Measures
Name Time Method 1. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ at the start and end of the informed consent period;<br /><br>2. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ between patients who consent or do not consent to treatment in a phase I or phase II cancer trial;<br /><br>3. Differences and relation between ‘motivation for treatment, hope, coping, locus of control and quality of life’ between patients who will or will not continue treatment after first response evaluation.