TriangleNCT00304031 · OUTCOME
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- baseline and cycle 1 (approximately 10 weeks)
What was measured
* The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
Analysis population: Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.
Groups in this outcome
Both Arms Combined
Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, either \[100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle\] or \[75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle\] for 6 cycles, up to 12 cycles.
| Group | Source count |
|---|---|
| Both Arms Combined | 136 |
Reported measurements
Source class 1
Symptom Severity and GHS deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 18 | Not reported | Not reported | Not reported | Not reported |
Symptom Severity deterioration only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 9 | Not reported | Not reported | Not reported | Not reported |
GHS deterioratoin only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 31 | Not reported | Not reported | Not reported | Not reported |
No deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 78 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Comment
- Two-sided test
- statistical Method
- Chi-squared
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.0002
- statistical Comment
- Two-sided test
- statistical Method
- Chi-squared
- classes
- categories
- measurements
- group Id
- OG000
- value
- 18
- title
- Symptom Severity and GHS deterioration
- measurements
- group Id
- OG000
- value
- 9
- title
- Symptom Severity deterioration only
- measurements
- group Id
- OG000
- value
- 31
- title
- GHS deterioratoin only
- measurements
- group Id
- OG000
- value
- 78
- title
- No deterioration
- denoms
- counts
- group Id
- OG000
- value
- 136
- units
- Participants
- description
- * The MDASI-BT is a 28-item patient-reported outcome measure assessing symptom severity (SS) and resulting interference with daily living in brain cancer patients. All items range from 0 (not present) to 10 (as bad as you can imagine). A SS score is the average of the SS items, given a specified minimum numbers were completed. A score worse than baseline by at least one is considered deterioration. * Global Health Status is calculated from two questions on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ\]-C30. The question responses range from 1 (very poor) to 7 (excellent) such that a higher response indicates better quality of life (QOL). The mean of these responses is linearly transformed to a range of 0 (worst) to 100 (best). A score worse than baseline by at least 10 is considered deterioration. * The 2x2 frequency table of SS deterioration vs. GHS deterioration is presented as four rows.
- groups
- description
- Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, either \[100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle\] or \[75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle\] for 6 cycles, up to 12 cycles.
- id
- OG000
- title
- Both Arms Combined
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Per the protocol, both arms are combined. Questionnaires were not completed by all QOL population participants. Therefore, only 136/191 have both MDASI-BT and EORTC QLQ-C30 at baseline and cycle 1.
- reporting Status
- POSTED
- time Frame
- baseline and cycle 1 (approximately 10 weeks)
- title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Symptom Severity Score and EORTC QLQ-C30 Global Health Status Score (GHS) at Cycle 1
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice