TriangleNCT01242800 · OUTCOME
Health-related Quality of Life (HRQL)
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
- Assessed at 18 months after randomization
What was measured
The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.
Analysis population: All randomized patients at step 2 who reported quality of life data at 18 months after randomization
Groups in this outcome
Arm I (Continued Systemic Therapy)
Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
Arm II (Early Local Therapy)
Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
| Group | Source count |
|---|---|
| Arm I (Continued Systemic Therapy) | 65 |
| Arm II (Early Local Therapy) | 66 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm I (Continued Systemic Therapy) | 74.2 | 11.5 | Not reported | Not reported | Not reported |
| Arm II (Early Local Therapy) | 68.0 | 13.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 11.5
- value
- 74.2
- group Id
- OG001
- spread
- 13.7
- value
- 68.0
- denoms
- counts
- group Id
- OG000
- value
- 65
- group Id
- OG001
- value
- 66
- units
- Participants
- description
- The Functional Assessment of Cancer Therapy-Breast Trial Outcome Index (FACT-B TOI) was used as the primary HRQL endpoint, measured by the prorated aggregate score of the 24 items from the FACT-B (7 functional well-being, 7 physical well-being, 10 breast cancer specific items). The theoretical range of the prorated aggregate score was 0-96, higher scores indicate better quality of life.
- dispersion Type
- Standard Deviation
- groups
- description
- Patients receive standard palliative therapy, if needed, to address symptoms such as tumor ulceration, pain, bulky adenopathy causing arm symptoms, and other similar situations. Therapy may consist of radiotherapy alone, surgery alone, or a combination of both. palliative surgery: Undergo standard palliative surgery palliative radiation therapy: Undergo standard palliative radiotherapy
- id
- OG000
- title
- Arm I (Continued Systemic Therapy)
- description
- Patients undergo surgery comprising breast-conserving therapy (BCT) or total mastectomy according to patient and treating physician preference. Surgery is to occur no later than 10 weeks after completion of 32 weeks of systemic therapy. Free surgical margins must be achieved with re-excision or mastectomy for patients undergoing BCT. After completion of BCT, patients undergo radiotherapy once a day, 5 days per week. Patients who had mastectomy undergo radiotherapy at the discretion of treating physician. therapeutic conventional surgery: Undergo early surgery radiation therapy: Undergo radiotherapy
- id
- OG001
- title
- Arm II (Early Local Therapy)
- param Type
- MEAN
- population Description
- All randomized patients at step 2 who reported quality of life data at 18 months after randomization
- reporting Status
- POSTED
- time Frame
- Assessed at 18 months after randomization
- title
- Health-related Quality of Life (HRQL)
- type
- SECONDARY
- unit Of Measure
- score on a scale
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice