Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma

Study Overview
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Brief Summary
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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.

Official Title
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Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Patients With Nasopharyngeal Carcinoma Undergoing Intensity Modulated Radiation Therapy: A Randomised Controlled Trial

Conditions
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Nasopharyngeal Neoplasms

Intervention / Treatment
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* Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
* Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patient reported group<br>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. | Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire<br>* The intervention was administrated through APP<br>|
| Active Comparator: non-reported group<br>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) | Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire<br>* patients receive normal care and visit<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |