Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
Not Applicable
- Conditions
- Nasopharyngeal Neoplasms
- Interventions
- Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaireOther: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
- Registration Number
- NCT03093649
- Lead Sponsor
- Sun Yat-sen University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 320
Inclusion Criteria
- Patients with newly histologically confirmed non-keratinizing carcinoma (according to WHO histological type)
- No evidence of distant metastasis (M0)
- Performance status: PS 0~2
- Receive standard treatment
- Able to read and understand the questionnaires
- Not exhibiting overt psychopathology
- Willing to give feedback to physicians and written informed consent was obtained
Exclusion Criteria
- WHO type keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
- Treatment with palliative intent.
- Prior malignancy (except adequately treated carcinoma in-situ of the cervix or basal/squamous cell carcinoma of the skin)
- Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume)
- Patient is pregnant or lactating
- Severe intercurrent disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description non-reported group do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire 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) patient reported group adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire 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.
- Primary Outcome Measures
Name Time Method Score of physical functioning in quality of life within 1 week of study completion Score of physical functioning in quality of life
- Secondary Outcome Measures
Name Time Method completion rate within 1 week of study completion completion rate
3-year progression-free survival 3 year after diagnosis progression-free survival at three year after diagnosis
3-year metastatic-free survival 3 year after diagnosis metastatic-free survival at three year after diagnosis
3-year overall survival 3 year after diagnosis overall survival at three year after diagnosis
3-year local-regional free survival 3 year after diagnosis local-regional free survival at three year after diagnosis
degrees of patients satisfaction regarding the treatment process within 1 week of study completion degrees of patients satisfaction regarding the treatment process
response rate 1 month after study completion response rate
Trial Locations
- Locations (1)
Sun Yat-sen University Cancer Center
🇨🇳Guangzhou, Guangdong, China