TriangleNCT01898494 · OUTCOME
Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
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
- 95% Confidence Interval
- Time frame
- Assessed at 6 months after treatment
What was measured
The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
Analysis population: Eligible and treated patients with FACT-HN total scores 6 months after treatment available
Groups in this outcome
Arm S (Surgery) Then Arm A (Low Risk, Observation)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
| Group | Source count |
|---|---|
| Arm S (Surgery) Then Arm A (Low Risk, Observation) | 21 |
| Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 75 |
| Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT) | 80 |
| Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy) | 77 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm S (Surgery) Then Arm A (Low Risk, Observation) | 128.5 | Not reported | 122.1 | 134.9 | Not reported |
| Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT) | 121.02 | Not reported | 116.5 | 125.5 | Not reported |
| Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT) | 117.8 | Not reported | 113.8 | 121.7 | Not reported |
| Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy) | 114.6 | Not reported | 109.3 | 119.9 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 122.1
- upper Limit
- 134.9
- value
- 128.5
- group Id
- OG001
- lower Limit
- 116.5
- upper Limit
- 125.5
- value
- 121.02
- group Id
- OG002
- lower Limit
- 113.8
- upper Limit
- 121.7
- value
- 117.8
- group Id
- OG003
- lower Limit
- 109.3
- upper Limit
- 119.9
- value
- 114.6
- denoms
- counts
- group Id
- OG000
- value
- 21
- group Id
- OG001
- value
- 75
- group Id
- OG002
- value
- 80
- group Id
- OG003
- value
- 77
- units
- Participants
- description
- The FACT-H\&N (version 4) consists of a cancer-specific questionnaire, FACT-G, in addition to 12 H\&N cancer-specific items (the HN subscale). FACT-G is a 27-item measure that assesses general cancer quality of life. FACT-HN total score ranges between 0 and 148. The higher the score, the better the QOL.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, low risk patients are under observation.
- id
- OG000
- title
- Arm S (Surgery) Then Arm A (Low Risk, Observation)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive low-dose IMRT (50 Gy) QD five days a week for 5 weeks.
- id
- OG001
- title
- Arm S (Surgery) Then Arm B (Intermediate Risk, Low-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, intermediate risk patients receive standard-dose IMRT (60 Gy) QD five days a week for 6 weeks.
- id
- OG002
- title
- Arm S (Surgery) Then Arm C (Intermediate Risk, Standard-dose IMRT)
- description
- Patients undergo transoral surgical resection of the oropharyngeal tumor. After transoral surgical resection of the oropharyngeal tumor, high risk patients then receive IMRT (66Gy) QD five days a week for 6-7 weeks. Patients also receive cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, 36, and 43 during radiation therapy.
- id
- OG003
- title
- Arm S (Surgery) Then Arm D (High Risk, IMRT, Chemotherapy)
- param Type
- MEAN
- population Description
- Eligible and treated patients with FACT-HN total scores 6 months after treatment available
- reporting Status
- POSTED
- time Frame
- Assessed at 6 months after treatment
- title
- Quality of Life (QOL) at 6 Months After Treatment Assessed by Functional Assessment of Cancer Therapy - Head and Neck Cancer (FACT-HN) Total Score
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice