TriangleNCT00304031 · OUTCOME
Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10
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 10 (approximately 46 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. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R deterioration is presented as four rows.
Analysis population: Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 36/191 have both MDASI-BT and HVLT-R at baseline and cycle 10.
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 | 36 |
Reported measurements
Source class 1
Cognitive and Delayed Recognition deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 3 | Not reported | Not reported | Not reported | Not reported |
Cognitive deterioration only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 6 | Not reported | Not reported | Not reported | Not reported |
Delayed Recognition deterioration only
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 4 | Not reported | Not reported | Not reported | Not reported |
No deterioration
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Both Arms Combined | 23 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33
- statistical Comment
- Two-sided test
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.33
- statistical Comment
- Two-sided test
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- title
- Cognitive and Delayed Recognition deterioration
- measurements
- group Id
- OG000
- value
- 6
- title
- Cognitive deterioration only
- measurements
- group Id
- OG000
- value
- 4
- title
- Delayed Recognition deterioration only
- measurements
- group Id
- OG000
- value
- 23
- title
- No deterioration
- denoms
- counts
- group Id
- OG000
- value
- 36
- 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. * The HVLT-R Delayed Recognition raw score is the number of of correctly identified words minus the number of incorrectly identified words from a list of words including 12 nouns memorized 20 minutes prior. The raw score ranges from -12 to 12. with a higher score indicates better functioning. Scores are standardized (mean 0, standard deviation 1), adjusting for age,education, and gender as necessary. A score worse than baseline by at least two is considered deterioration. * The 2x2 frequency table of SS deterioration vs. HVLT-R 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
- Both arms are combined per the protocol. Questionnaires/assessments were not completed by all QOL population participants. Therefore, only 36/191 have both MDASI-BT and HVLT-R at baseline and cycle 10.
- reporting Status
- POSTED
- time Frame
- baseline and cycle 10 (approximately 46 weeks)
- title
- Number of Participants With Deterioration From Baseline in MD Anderson Symptom Inventory Brain Tumor (MDASI-BT) Cognitive Score and Hopkins Verbal Learning Test - Revised (HVLT-R) Delayed Recognition (DR) Score at Cycle 10
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice