TriangleNCT01920932 · OUTCOME
Patient Quality of Life (QoL)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- score on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
What was measured
Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
Analysis population: Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.
Groups in this outcome
Timepoint 1 (T1)
At Diagnosis (baseline)
Timepoint 4 (T4)
Course 2 Day 1
Timepoint 6 (T6)
Course 3 Day 1
Timepoint 8 (T8)
Course 6 Day 1
Timepoint 10 (T10)
4-6 weeks after chemotherapy or 4-6 weeks after radiation
Timepoint 11 (T11)
1 year off therapy
Timepoint 12 (T12)
2 years off therapy (approximately 2 years and 8 months
Timepoint 13 (T13)
5 years off therapy (approximately 5 years and 8 months)
| Group | Source count |
|---|---|
| Timepoint 1 (T1) | 63 |
| Timepoint 4 (T4) | 64 |
| Timepoint 6 (T6) | 62 |
| Timepoint 8 (T8) | 58 |
| Timepoint 10 (T10) | 52 |
| Timepoint 11 (T11) | 51 |
| Timepoint 12 (T12) | 39 |
| Timepoint 13 (T13) | 35 |
Reported measurements
Physical Functioning
| Group | Source count |
|---|---|
| Timepoint 1 (T1) | 63 |
| Timepoint 4 (T4) | 64 |
| Timepoint 6 (T6) | 62 |
| Timepoint 8 (T8) | 58 |
| Timepoint 10 (T10) | 52 |
| Timepoint 11 (T11) | 51 |
| Timepoint 12 (T12) | 39 |
| Timepoint 13 (T13) | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Timepoint 1 (T1) | 69.5 | 21.8 | Not reported | Not reported | Not reported |
| Timepoint 4 (T4) | 75.8 | 21.8 | Not reported | Not reported | Not reported |
| Timepoint 6 (T6) | 73.9 | 24.1 | Not reported | Not reported | Not reported |
| Timepoint 8 (T8) | 74 | 22.1 | Not reported | Not reported | Not reported |
| Timepoint 10 (T10) | 82.5 | 23.2 | Not reported | Not reported | Not reported |
| Timepoint 11 (T11) | 87.7 | 20.3 | Not reported | Not reported | Not reported |
| Timepoint 12 (T12) | 87.1 | 20.7 | Not reported | Not reported | Not reported |
| Timepoint 13 (T13) | 88.8 | 19.4 | Not reported | Not reported | Not reported |
Emotional Functioning
| Group | Source count |
|---|---|
| Timepoint 1 (T1) | 63 |
| Timepoint 4 (T4) | 64 |
| Timepoint 6 (T6) | 62 |
| Timepoint 8 (T8) | 58 |
| Timepoint 10 (T10) | 52 |
| Timepoint 11 (T11) | 51 |
| Timepoint 12 (T12) | 39 |
| Timepoint 13 (T13) | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Timepoint 1 (T1) | 71.7 | 24.4 | Not reported | Not reported | Not reported |
| Timepoint 4 (T4) | 80.3 | 20.2 | Not reported | Not reported | Not reported |
| Timepoint 6 (T6) | 83.1 | 16.6 | Not reported | Not reported | Not reported |
| Timepoint 8 (T8) | 82.1 | 18.4 | Not reported | Not reported | Not reported |
| Timepoint 10 (T10) | 84.8 | 19.8 | Not reported | Not reported | Not reported |
| Timepoint 11 (T11) | 88.4 | 18.8 | Not reported | Not reported | Not reported |
| Timepoint 12 (T12) | 88.2 | 16.4 | Not reported | Not reported | Not reported |
| Timepoint 13 (T13) | 80.9 | 22.8 | Not reported | Not reported | Not reported |
Social Functioning
| Group | Source count |
|---|---|
| Timepoint 1 (T1) | 63 |
| Timepoint 4 (T4) | 64 |
| Timepoint 6 (T6) | 62 |
| Timepoint 8 (T8) | 58 |
| Timepoint 10 (T10) | 52 |
| Timepoint 11 (T11) | 50 |
| Timepoint 12 (T12) | 39 |
| Timepoint 13 (T13) | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Timepoint 1 (T1) | 86.2 | 17 | Not reported | Not reported | Not reported |
| Timepoint 4 (T4) | 87.2 | 18.3 | Not reported | Not reported | Not reported |
| Timepoint 6 (T6) | 88.5 | 15.9 | Not reported | Not reported | Not reported |
| Timepoint 8 (T8) | 90.2 | 12.4 | Not reported | Not reported | Not reported |
| Timepoint 10 (T10) | 92.3 | 11.6 | Not reported | Not reported | Not reported |
| Timepoint 11 (T11) | 93.8 | 11.9 | Not reported | Not reported | Not reported |
| Timepoint 12 (T12) | 94 | 12.8 | Not reported | Not reported | Not reported |
| Timepoint 13 (T13) | 95.3 | 12.2 | Not reported | Not reported | Not reported |
School Functioning
| Group | Source count |
|---|---|
| Timepoint 1 (T1) | 61 |
| Timepoint 4 (T4) | 58 |
| Timepoint 6 (T6) | 61 |
| Timepoint 8 (T8) | 56 |
| Timepoint 10 (T10) | 50 |
| Timepoint 11 (T11) | 50 |
| Timepoint 12 (T12) | 39 |
| Timepoint 13 (T13) | 35 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Timepoint 1 (T1) | 65.5 | 22.7 | Not reported | Not reported | Not reported |
| Timepoint 4 (T4) | 75.7 | 24.3 | Not reported | Not reported | Not reported |
| Timepoint 6 (T6) | 75.7 | 24.7 | Not reported | Not reported | Not reported |
| Timepoint 8 (T8) | 79.2 | 21.5 | Not reported | Not reported | Not reported |
| Timepoint 10 (T10) | 86.9 | 18.6 | Not reported | Not reported | Not reported |
| Timepoint 11 (T11) | 85.4 | 16.2 | Not reported | Not reported | Not reported |
| Timepoint 12 (T12) | 87.2 | 13.1 | Not reported | Not reported | Not reported |
| Timepoint 13 (T13) | 81.5 | 23.1 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 21.8
- value
- 69.5
- group Id
- OG001
- spread
- 21.8
- value
- 75.8
- group Id
- OG002
- spread
- 24.1
- value
- 73.9
- group Id
- OG003
- spread
- 22.1
- value
- 74
- group Id
- OG004
- spread
- 23.2
- value
- 82.5
- group Id
- OG005
- spread
- 20.3
- value
- 87.7
- group Id
- OG006
- spread
- 20.7
- value
- 87.1
- group Id
- OG007
- spread
- 19.4
- value
- 88.8
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 58
- group Id
- OG004
- value
- 52
- group Id
- OG005
- value
- 51
- group Id
- OG006
- value
- 39
- group Id
- OG007
- value
- 35
- units
- Participants
- title
- Physical Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 24.4
- value
- 71.7
- group Id
- OG001
- spread
- 20.2
- value
- 80.3
- group Id
- OG002
- spread
- 16.6
- value
- 83.1
- group Id
- OG003
- spread
- 18.4
- value
- 82.1
- group Id
- OG004
- spread
- 19.8
- value
- 84.8
- group Id
- OG005
- spread
- 18.8
- value
- 88.4
- group Id
- OG006
- spread
- 16.4
- value
- 88.2
- group Id
- OG007
- spread
- 22.8
- value
- 80.9
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 58
- group Id
- OG004
- value
- 52
- group Id
- OG005
- value
- 51
- group Id
- OG006
- value
- 39
- group Id
- OG007
- value
- 35
- units
- Participants
- title
- Emotional Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 17
- value
- 86.2
- group Id
- OG001
- spread
- 18.3
- value
- 87.2
- group Id
- OG002
- spread
- 15.9
- value
- 88.5
- group Id
- OG003
- spread
- 12.4
- value
- 90.2
- group Id
- OG004
- spread
- 11.6
- value
- 92.3
- group Id
- OG005
- spread
- 11.9
- value
- 93.8
- group Id
- OG006
- spread
- 12.8
- value
- 94
- group Id
- OG007
- spread
- 12.2
- value
- 95.3
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 58
- group Id
- OG004
- value
- 52
- group Id
- OG005
- value
- 50
- group Id
- OG006
- value
- 39
- group Id
- OG007
- value
- 35
- units
- Participants
- title
- Social Functioning
- categories
- measurements
- group Id
- OG000
- spread
- 22.7
- value
- 65.5
- group Id
- OG001
- spread
- 24.3
- value
- 75.7
- group Id
- OG002
- spread
- 24.7
- value
- 75.7
- group Id
- OG003
- spread
- 21.5
- value
- 79.2
- group Id
- OG004
- spread
- 18.6
- value
- 86.9
- group Id
- OG005
- spread
- 16.2
- value
- 85.4
- group Id
- OG006
- spread
- 13.1
- value
- 87.2
- group Id
- OG007
- spread
- 23.1
- value
- 81.5
- denoms
- counts
- group Id
- OG000
- value
- 61
- group Id
- OG001
- value
- 58
- group Id
- OG002
- value
- 61
- group Id
- OG003
- value
- 56
- group Id
- OG004
- value
- 50
- group Id
- OG005
- value
- 50
- group Id
- OG006
- value
- 39
- group Id
- OG007
- value
- 35
- units
- Participants
- title
- School Functioning
- denoms
- counts
- group Id
- OG000
- value
- 63
- group Id
- OG001
- value
- 64
- group Id
- OG002
- value
- 62
- group Id
- OG003
- value
- 58
- group Id
- OG004
- value
- 52
- group Id
- OG005
- value
- 51
- group Id
- OG006
- value
- 39
- group Id
- OG007
- value
- 35
- units
- Participants
- description
- Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If \>50% of the items are missing the score should not be computed. If \>50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.
- dispersion Type
- Standard Deviation
- groups
- description
- At Diagnosis (baseline)
- id
- OG000
- title
- Timepoint 1 (T1)
- description
- Course 2 Day 1
- id
- OG001
- title
- Timepoint 4 (T4)
- description
- Course 3 Day 1
- id
- OG002
- title
- Timepoint 6 (T6)
- description
- Course 6 Day 1
- id
- OG003
- title
- Timepoint 8 (T8)
- description
- 4-6 weeks after chemotherapy or 4-6 weeks after radiation
- id
- OG004
- title
- Timepoint 10 (T10)
- description
- 1 year off therapy
- id
- OG005
- title
- Timepoint 11 (T11)
- description
- 2 years off therapy (approximately 2 years and 8 months
- id
- OG006
- title
- Timepoint 12 (T12)
- description
- 5 years off therapy (approximately 5 years and 8 months)
- id
- OG007
- title
- Timepoint 13 (T13)
- param Type
- MEAN
- population Description
- Each institution made the decision whether to complete the QoL objective. Participation in the Quality of Life part of the trial is voluntary for participating institutions and voluntary by patient.
- reporting Status
- POSTED
- time Frame
- At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
- title
- Patient Quality of Life (QoL)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice