1. Level of decisional conflict (Time Frame - Baseline): Level of decisional conflict will be measured with the Decision Conflict Scale that assesses patients' perceptions of uncertainty, modifiable factors con-tributing to uncertainty, and ultimate satisfaction with the choice. It is one of the most robust and validated instruments to test the impact of decision aids also in end-of-life decision making. It has 16 items and 5 response categories, ranging from "0" -strongly agree till "4"-strongly disagree
2. Level of decisional conflict (Time Frame - 26 weeks): Level of decisional conflict will be measured with the Decision Conflict Scale that assesses patients' perceptions of uncertainty, modifiable factors con-tributing to uncertainty, and ultimate satisfaction with the choice. It is one of the most robust and validated instruments to test the impact of decision aids also in end-of-life decision making. It has 16 items and 5 response categories, ranging from "0" -strongly agree till "4"-strongly disagree
Secondary outcome:
1. Patients' involvement in decision-making (Time Frame - Baseline): Patients' involvement in decision-making will be assessed with the German questionnaire on shared decision making. It has 9 items with 6-points Likert scale, ranging from "0-not at all" till "6 -fully correct". The higher score means more shared decision making.
2. Patients' involvement in decision-making (Time Frame - 26 weeks): Patients' involvement in decision-making will be assessed with the German questionnaire on shared decision making. It has 9 items with 6-points Likert scale, ranging from "0-not at all" till "6 -fully correct". The higher score means more shared decision making.
3. The trade-off between patients' preferences for quality and length of life (Time Frame - Baseline): The trade-off between patients' preferences for quality and length of life will be assessed with the German validated version of "Quality and Quantity Questionnaire" The questionnaire consists of nine items in two preference dimensions: Q(uality) of life (QL) and L(ength) of life (LL).
Patients indicate how strongly they agree or disagree with the statements on a 5-point Likert scale. High scores on the quantity or quality scale indicate the importance of length or quality of life, respectively.
4. The trade-off between patients' preferences for quality and length of life (Time Frame - 26 weeks): The trade-off between patients' preferences for quality and length of life will be assessed with the German validated version of "Quality and Quantity Questionnaire" The questionnaire consists of nine items in two preference dimensions: Q(uality) of life (QL) and L(ength) of life (LL).
Patients indicate how strongly they agree or disagree with the statements on a 5-point Likert scale. High scores on the quantity or quality scale indicate the importance of length or quality of life, respectively.
5. Preferred role of the patient in decision-making (Time Frame - Baseline): Preferred role of the patient in decision-making will be assessed with a German version of the Control Preference Scale (CPS). It consists of five statement (A, B, C, D, E) that each portrays a different role in treatment decision-making. For analysis a categorical variable, which is the person's most preferred role in treatment decision-making, will be created. Preference orders will be reclassified into Active (A, B), Collaborative ( C) and Passive (D, E). Ordinal categorical analysis can be applied.
6. Preferred role of the patient in decision-making (Time Frame - 26 weeks): Preferred role of the patient in decision-making will be assessed with a German version of the Control Preference Scale (CPS). It consists of five statement (A, B, C, D, E) that each portrays a different role in treatment decision-making. For analysis a categorical variable, which is the person's most preferred role in treatment decision-making, will be created. Preference orders will be reclassified into Active (A, B), Collaborative ( C) and Passive (D, E).Ordinal categorical analysis can be applied.
7. Satisfaction with the oncologist-patient interaction (Time Frame - Baseline): Satisfaction with the oncologist-patient interaction will be assessed using the validated questionnaire on the Quality of Physician-Patient Interaction (QQPPI). It has 14 Items with a 5-point scale (range: 1 [I do not agree] to 5 [I fully agree]).
8. Satisfaction with the oncologist-patient interaction (Time Frame - 26 weeks): Satisfaction with the oncologist-patient interaction will be assessed using the validated questionnaire on the Quality of Physician-Patient Interaction (QQPPI). It has 14 Items with a 5-point scale (range: 1 [I do not agree] to 5 [I fully agree]).
9. Effect on hope (Time Frame - Baseline): Effect on hope will be assessed with a German Version of the Herth Hope Index (HHI-D). It has 12 items with a 4-point Likert scale. Higher scores indicate more hope.
10. Effect on hope (Time Frame - 26 weeks): Effect on hope will be assessed with a German Version of the Herth Hope Index (HHI-D). It has 12 items with a 4-point Likert scale. Higher scores indicate more hope.
11. Effect on patients' quality of life (Time Frame - Baseline): Quality of life will be assessed with the EORTC QLQ-C30, a questionnaire developed to measure the quality of life of cancer patients. The QLQ-C30 has global health status, five functional scales, and three symptom scales. High scores of functional scales means healthy functioning. A high score for global health status means a higher quality of life. A high score of symptom scales demonstrates a high level of problems. Scores for all scales and single items range from 0 to 100.
12. Effect on patients' quality of life (Time Frame - 26 weeks): Quality of life will be assessed with the EORTC QLQ-C30, a questionnaire developed to measure the quality of life of cancer patients. The QLQ-C30 has global health status, five functional scales, and three symptom scales. High scores of functional scales means healthy functioning. A high score for global health status means a higher quality of life. A high score of symptom scales demonstrates a high level of problems. Scores for all scales and single items range from 0 to 100.
No Intervention: Group without DA adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
Other: Group with DA adult patients with incurable, stage IV disease (Prostate-, Breast-, Pancreatic-, Stomach- and Colorectal cancer) in an advanced treatment stage.
Decision Aid: Oncologists and patients will use the decision aid in the same situation (change of treatment needs to be discussed with the patient - either because of disease progression or treatment toxicity or other reasons (e.g. change of care setting).
Quelle: ClinicalTrials.gov
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"Decision Aid to Support Advanced Cancer Patients"
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