Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Overall perceived self-efficacy |
Overall perceived self-efficacy is measured by a specifically developed questionnaire (questionnaire SWE). Analysis will be descriptive, separate for each group and performed according to the analysis manual. A difference between the groups is defined as 10% difference in median between the groups. The scale ranges from 10 to 40 points. The higher the score, the higher is perceived self-efficacy of the patient. |
The questionnaire SWE is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Overall quality of life |
Overall quality of life is measured by the questionnaire FACT-G. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 108 points. The higher the score, the better is quality of life. |
The questionnaire FACT-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Disease-related quality of life |
Disease-related quality of life is measured by the questionnaire FACT-B. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 148 points. The higher the score, the better is quality of life. |
The questionnaire FACT-B is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Active coping with the disease |
Active coping with the disease is measured by the questionnaire FKV-15. Differences between the groups will be determined comparing total score. The scale ranges from 15 to 75 points. The higher the score, the better the patient is coping. |
The questionnaire FKV-15 is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Physical activity |
Physical activity is measured by the questionnaire IPAQ. Differences between the groups will be determined comparing the level of physical activity. Analysis will be done according to the scoring manual. There is no minimum or maximum for the scale, the outcome is a continuous measure presented in Metabolic Equivalent of Task (MET)-minutes. The higher the outcome, the higher is the level of physical activity. |
The questionnaire IPAQ is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Duration of hormone therapy |
Duration of hormone therapy is determined by the questionnaire Compliance which consists of two items. Total duration of hormone therapy is measured in months and is compared between the groups. The questionnaire Compliance only applies to patients who receive hormone therapy. |
The questionnaire Compliance is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Anxiety levels |
Anxiety levels are measured by the questionnaire GAD-7. Analysis will be done according to the scoring manual. Differences between the groups will be determined comparing total score. The scale ranges from 0 to 21 points. The higher the score, the higher the level of anxiety. |
The questionnaire GAD-7 is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Use of complementary medicine |
Use of complementary medicine is measured by the questionnaire I-CAM-G. The number of complementary medical measures is determined descriptively and compared between the groups. |
The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
|
Secondary |
Rate of Relapse |
Occurrence of relapse is documented during the course of the study. The occurence of relapse is assessed by the investigator as per clinical routine and documented in the eCRF by three items. |
Occurrence of relapse is assessed at the timepoint of relapse or at 7.5 months, whichever comes first. |
|
Secondary |
Change of perceived self-efficacy |
Change of perceived self-efficacy is measured by a specifically developed questionnaire (questionnaire SWE) and compared between the groups. An increase in perceived self-efficacy is defined as the first increase in total score of five or more points. The scale ranges from 10 to 40 points. The higher the score, the higher is perceived self-efficacy of the patient. |
The questionnaire SWE is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months. |
|
Secondary |
Change of quality of life |
Change of quality of life is measured by the questionnaire FACT-G and compared between the groups. An increase in quality of life is defined as the first increase in total score of five or more points. The scale ranges from 0 to 108 points. The higher the score, the better is quality of life. |
The questionnaire FACT-G is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months. |
|
Secondary |
Change of disease-related quality of life |
Change of disease-related quality of life is measured by the questionnaire FACT-B and compared between the groups. An increase in disease related quality of life is defined as the first increase in total score of five or more points. The scale ranges from 0 to 148 points. The higher the score, the better is quality of life. |
The questionnaire FACT-B is collected at baseline, after 1.5 months, 4.5 months and at the timepoint of relapse or latest after 7.5 months. |
|
Secondary |
Depression |
Depression is measured by the questionnaire PHQ-9. Differences between the groups will be determined comparing total score. Analysis will be done according to the scoring manual. The scale ranges from 0 to 27 points. The higher the score, the higher the level of depression. |
The questionnaire PHQ-9 is collected at the timepoint of relapse or latest after 7.5 months, whichever comes first. |
|
Secondary |
Use of micronutrients |
Use of micronutrients is measured by the questionnaire I-CAM-G. The number of different types of micronutrients is determined descriptively and compared between the groups. |
The questionnaire I-CAM-G is collected at the timepoint of relapse or after 7.5 months, whichever comes first. |
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