HELP II - Heidelberg decicion aids for lung Cancer patients and their implementatio
Not Applicable
- Conditions
- TREATMENT DECISIONS IN METASTATIC LUNG CANCER
- Registration Number
- DRKS00028023
- Lead Sponsor
- Bristol Myers Squibb-Stiftung Immunonkologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 138
Inclusion Criteria
at least 18 years old; capable of giving consent; good knowledge of German; Diagnosis of incurable stage IV lung cancer and stadium IIIb and IIIc; willingness to participate in the study.
Exclusion Criteria
Knowledge of German is not sufficient; is in a state of health that does not allow conversation due to a vital threat; has limitations in cognitive function, minor, incapacitated.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcome is the sum score of the Clarity of Personal Attitude dimension of the Decisional Conflict Scale (DCS). In addition to the descriptive evaluation of the target variable, its analysis is carried out by means of group comparisons (nonparametric comparison: van elteren test) between the two study groups in which the stratification of randomization is taken into account. Missing values in the primary outcome are replaced by multiple imputation.
- Secondary Outcome Measures
Name Time Method Decision Self-Efficacy Scale <br>Patient Involvement in Care Scale (PICS) <br>Preparation for Decision-Making Scale (PDMS-D) <br>EQ5D-5L <br>HADS-D<br>Focus groups with healthcare professionals<br><br>For the sum scores and scales of the secondary target variables, group comparisons (with consideration of stratification) are also carried out in order to be able to determine significant differences. Depending on the group, the Cochran-Mantel-Haenszel test, the van Elteren test, or a covariance analysis are used.