Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Although patient-reported adverse events have been promoted as an essential element in clinical trials and daily managements, their efficacy remained unknown. The purpose of this trial was to determine the effect of the patient-reported adverse events during the treatment on the improvements on quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patient reported group | Experimental | Patients reported adverse events using patient reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) through Application (APP) during the treatment. The summary report was transferred to their clinician immediately. Oncologists would be alarmed if patients reports exceeding the pre-defined threshold. |
|
| non-reported group | Active Comparator | Patients in this group received normal care during the treatment without completing patient reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire | Other | The intervention was administrated through APP |
| Measure | Description | Time Frame |
|---|---|---|
| Score of physical functioning in quality of life | Score of physical functioning in quality of life | within 1 week of study completion |
| Measure | Description | Time Frame |
|---|---|---|
| 3-year overall survival | overall survival at three year after diagnosis | 3 year after diagnosis |
| 3-year progression-free survival | progression-free survival at three year after diagnosis |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Guangzhou | Guangdong | 510060 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire | Other | patients receive normal care and visit |
|
| 3 year after diagnosis |
| 3-year local-regional free survival | local-regional free survival at three year after diagnosis | 3 year after diagnosis |
| 3-year metastatic-free survival | metastatic-free survival at three year after diagnosis | 3 year after diagnosis |
| completion rate | completion rate | within 1 week of study completion |
| degrees of patients satisfaction regarding the treatment process | degrees of patients satisfaction regarding the treatment process | within 1 week of study completion |
| response rate | response rate | 1 month after study completion |
| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
Not provided
Not provided