NCT03067610 · OUTCOME
Quality of Life (QOL) Patient Reported Outcomes (PRO)
Involved Field Elective Volume De-Intensification Radiation Therapy for Head and Neck Cancer · Source last updated 2022-03-17
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 Error
- Time frame
- 12 months
What was measured
Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI).
EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms.
MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
Groups in this outcome
Total Cohort Baseline
Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
Total Cohort 3 Month
Total cohort
Total Cohort 6 Month
Total cohort
Total Cohort 12 Month
Total cohort
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Total Cohort Baseline | 72 |
|---|
| Total Cohort 3 Month | 57 |
|---|
| Total Cohort 6 Month | 44 |
|---|
| Total Cohort 12 Month | 43 |
|---|
Reported measurements
EORTC QLQ30 global
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 71.4 | 2.3 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 76.9 | 2.6 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 79.2 | 2.8 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 85.9 | 2.3 | Not reported | Not reported | Not reported |
|---|
EORTC QLQ30 physical fcn
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 90.3 | 1.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 87.4 | 2.3 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 90.3 | 2.4 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 93.0 | 1.8 | Not reported | Not reported | Not reported |
|---|
EORTC QLQ30 role fcn
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 81.9 | 3.0 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 82.5 | 3.4 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 85.6 | 3.6 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 95.3 | 2.2 | Not reported | Not reported | Not reported |
|---|
EORTC QLQ30 emotional fcn
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 78.0 | 2.8 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 87.7 | 2.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 82.9 | 3.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 88.2 | 3.2 | Not reported | Not reported | Not reported |
|---|
EORTC QLQ30 cognitive fcn
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 90.0 | 1.9 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 89.5 | 2.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 86.4 | 3.1 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 90.7 | 2.9 | Not reported | Not reported | Not reported |
|---|
EORTC QLQ30 social fcn
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 85.2 | 2.4 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 85.1 | 3.5 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 85.6 | 3.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 90.3 | 3.4 | Not reported | Not reported | Not reported |
|---|
EORTC HN35 dry mouth
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 14.4 | 2.8 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 59.0 | 4.1 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 47.7 | 4.5 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 38.0 | 4.2 | Not reported | Not reported | Not reported |
|---|
EORTC HN35 sticky saliva
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 15.7 | 3.2 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 38.0 | 4.4 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 27.3 | 4.4 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 27.1 | 4.6 | Not reported | Not reported | Not reported |
|---|
EORTC HN35 senses
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 6.7 | 1.8 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 25.7 | 2.9 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 20.1 | 3.3 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 15.9 | 2.7 | Not reported | Not reported | Not reported |
|---|
EORTC HN35 pain
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 24.4 | 2.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 16.5 | 2.7 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 14.2 | 3.3 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 7.9 | 2.3 | Not reported | Not reported | Not reported |
|---|
EORTC HN35 speech
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 18.4 | 2.9 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 13.4 | 2.6 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 19.2 | 4.5 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 9.8 | 2.6 | Not reported | Not reported | Not reported |
|---|
Composite MDADI
Values in score on a scale · Interval/dispersion: Standard Error| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Total Cohort Baseline | 81.3 | 1.9 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 3 Month | 79.6 | 2.0 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 6 Month | 76.9 | 2.6 | Not reported | Not reported | Not reported |
|---|
| Total Cohort 12 Month | 84.9 | 2.3 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 2.3
- value
- 71.4
- group Id
- OG001
- spread
- 2.6
- value
- 76.9
- group Id
- OG002
- spread
- 2.8
- value
- 79.2
- group Id
- OG003
- spread
- 2.3
- value
- 85.9
- title
- EORTC QLQ30 global
- categories
- measurements
- group Id
- OG000
- spread
- 1.7
- value
- 90.3
- group Id
- OG001
- spread
- 2.3
- value
- 87.4
- group Id
- OG002
- spread
- 2.4
- value
- 90.3
- group Id
- OG003
- spread
- 1.8
- value
- 93.0
- title
- EORTC QLQ30 physical fcn
- categories
- measurements
- group Id
- OG000
- spread
- 3.0
- value
- 81.9
- group Id
- OG001
- spread
- 3.4
- value
- 82.5
- group Id
- OG002
- spread
- 3.6
- value
- 85.6
- group Id
- OG003
- spread
- 2.2
- value
- 95.3
- title
- EORTC QLQ30 role fcn
- categories
- measurements
- group Id
- OG000
- spread
- 2.8
- value
- 78.0
- group Id
- OG001
- spread
- 2.7
- value
- 87.7
- group Id
- OG002
- spread
- 3.7
- value
- 82.9
- group Id
- OG003
- spread
- 3.2
- value
- 88.2
- title
- EORTC QLQ30 emotional fcn
- categories
- measurements
- group Id
- OG000
- spread
- 1.9
- value
- 90.0
- group Id
- OG001
- spread
- 2.7
- value
- 89.5
- group Id
- OG002
- spread
- 3.1
- value
- 86.4
- group Id
- OG003
- spread
- 2.9
- value
- 90.7
- title
- EORTC QLQ30 cognitive fcn
- categories
- measurements
- group Id
- OG000
- spread
- 2.4
- value
- 85.2
- group Id
- OG001
- spread
- 3.5
- value
- 85.1
- group Id
- OG002
- spread
- 3.7
- value
- 85.6
- group Id
- OG003
- spread
- 3.4
- value
- 90.3
- title
- EORTC QLQ30 social fcn
- categories
- measurements
- group Id
- OG000
- spread
- 2.8
- value
- 14.4
- group Id
- OG001
- spread
- 4.1
- value
- 59.0
- group Id
- OG002
- spread
- 4.5
- value
- 47.7
- group Id
- OG003
- spread
- 4.2
- value
- 38.0
- title
- EORTC HN35 dry mouth
- categories
- measurements
- group Id
- OG000
- spread
- 3.2
- value
- 15.7
- group Id
- OG001
- spread
- 4.4
- value
- 38.0
- group Id
- OG002
- spread
- 4.4
- value
- 27.3
- group Id
- OG003
- spread
- 4.6
- value
- 27.1
- title
- EORTC HN35 sticky saliva
- categories
- measurements
- group Id
- OG000
- spread
- 1.8
- value
- 6.7
- group Id
- OG001
- spread
- 2.9
- value
- 25.7
- group Id
- OG002
- spread
- 3.3
- value
- 20.1
- group Id
- OG003
- spread
- 2.7
- value
- 15.9
- title
- EORTC HN35 senses
- categories
- measurements
- group Id
- OG000
- spread
- 2.7
- value
- 24.4
- group Id
- OG001
- spread
- 2.7
- value
- 16.5
- group Id
- OG002
- spread
- 3.3
- value
- 14.2
- group Id
- OG003
- spread
- 2.3
- value
- 7.9
- title
- EORTC HN35 pain
- categories
- measurements
- group Id
- OG000
- spread
- 2.9
- value
- 18.4
- group Id
- OG001
- spread
- 2.6
- value
- 13.4
- group Id
- OG002
- spread
- 4.5
- value
- 19.2
- group Id
- OG003
- spread
- 2.6
- value
- 9.8
- title
- EORTC HN35 speech
- categories
- measurements
- group Id
- OG000
- spread
- 1.9
- value
- 81.3
- group Id
- OG001
- spread
- 2.0
- value
- 79.6
- group Id
- OG002
- spread
- 2.6
- value
- 76.9
- group Id
- OG003
- spread
- 2.3
- value
- 84.9
- title
- Composite MDADI
- denoms
- counts
- group Id
- OG000
- value
- 72
- group Id
- OG001
- value
- 57
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 43
- units
- Participants
- description
- Quality of life (QOL) patient-reported outcomes (PRO) for overall number of participants following treatment with elective volume and dose de-escalation, using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), EORTC HN35, which is specific to head and neck cancer, and composite MD Anderson Dysphagia Inventory (MDADI).
EORTC QLQ-C30 and QLQ-H\&N35 are scored on a 4-point categorical scale ranging from 1 "not at all" to 4 "very much". This scale is then linearly transformed to a 0-100 scale, where a higher score represents a higher response level. A high score for a functional scale represents higher level functioning, a high score for quality of life represents a high quality of life, and a high score for a symptom scale represents worse symptoms.
MD Anderson Dysphagia Inventory (MDADI) questionnaire: Possible score ranges from 0-100, with higher score indicating higher functioning.
- dispersion Type
- Standard Error
- groups
- description
- Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
Intensity Modulated Radiation Therapy: The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
chemotherapy: chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
- id
- OG000
- title
- Total Cohort Baseline
- description
- Total cohort
- id
- OG001
- title
- Total Cohort 3 Month
- description
- Total cohort
- id
- OG002
- title
- Total Cohort 6 Month
- description
- Total cohort
- id
- OG003
- title
- Total Cohort 12 Month
- param Type
- MEAN
- reporting Status
- POSTED
- time Frame
- 12 months
- title
- Quality of Life (QOL) Patient Reported Outcomes (PRO)
- type
- SECONDARY
- unit Of Measure
- score on a scale
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Preserved source evidence · Not medical advice
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