Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in Global quality of life using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire core 30 from baseline (week 1) through to 12 weeks (to day 1 of cycle 4 of trabectedin). |
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100. |
Through to study completion, an average of 12 weeks |
|
Primary |
What is the trajectory in the subscales and symptom scales in the scale, from baseline (day 1 cycle 1) to day 1 cycle 4, day 1 cycle 7 and day 1 cycle 10 etc of Trabectedin? |
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100. |
Through to study completion, an average of 12 weeks |
|
Primary |
What is the association between patient's prior treatment (second line versus third line) and the trajectory of the subscales and symptom scales in the EORTC QLQc30 ? |
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100. |
Through to study completion, an average of 12 weeks |
|
Primary |
What is the association between patient age (in deciles) and the trajectory of the subscales and symptom scales in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale? |
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100. |
Through to study completion, an average of 12 weeks |
|
Primary |
What is the relationship between the trajectory of responses in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 scale and the growth modulation index? |
As this is a pilot exploratory study the investigators will have multiple co-primary outcomes.The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) is a 30 question assessment of quality of life in the following categories: global health status, physical functioning, role functioning, emotional functioning, cognitive functioning, social functioning, fatigue, nausea and vomiting, pain, dyspnoea, insomnia, appetite loss, constipation, diarrhoea, and financial difficulties. Twenty-eight questions are assessed on a scale of 1 (Not at all) to 4 (Very much); 2 questions are assessed on a scale of 1 (very poor) to 7 (excellent). The range of scores on each scale is from 0 to 100. In the function scales, a score of 100 is best (indicating more function). In the symptom scores, a score of 100 is worst, indicating more symptoms. Scores are totalled from each item to form the scales, then normalised to 0-100. |
Through to study completion, an average of 12 weeks |
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