TriangleNCT04158141 · OUTCOME
Change From Randomization to 9 Months in Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- Randomization and 9 months
What was measured
Global Health Status is calculated from two questions on the 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).
Analysis population: No patients had both baseline and 9-month data, therefore change from baseline could not be calculated for any patient.
Groups in this outcome
Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
\[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.
Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
\[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
| Group | Source count |
|---|---|
| Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment) | 0 |
| Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- units
- Participants
- description
- Global Health Status is calculated from two questions on the 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).
- groups
- description
- \[Intent-to-treat\] STEP 1 (all patients): Patients who received allowed neoadjuvant systemic therapy before study entry undergo pleurectomy/decortication (P/D) within 4 to 8 weeks of systemic therapy. Otherwise, patients undergo P/D within 4 weeks of study entry followed within 4 to 8 weeks by four 21-day cycles of pemetrexed and cisplatin or carboplatin on day 1. STEP 2 (randomized): Patients receive no treatment.
- id
- OG000
- title
- Arm I (Step 1: Chemotherapy, P/D: Step 2: no Treatment)
- description
- \[Intent-to-treat\] STEP 1 (all patients): Same as Arm 1. STEP 2 (randomized): Within 4-8 weeks from the end of Step 1 treatment, patients undergo 25-28 fractions of intensity modulated radiation therapy (IMRT) or pencil beam scanning (PBS) proton therapy 5 days/week over 6 weeks.
- id
- OG001
- title
- Arm II (Step 1: Chemotherapy, P/D, Step 2: IMRT/PBS)
- population Description
- No patients had both baseline and 9-month data, therefore change from baseline could not be calculated for any patient.
- reporting Status
- POSTED
- time Frame
- Randomization and 9 months
- title
- Change From Randomization to 9 Months in Global Heath Status (GHS) Score of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice