Clinical trial · Interventional
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Neoplasms | Nasopharyngeal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire | Other | — | UNRESOLVED |
| do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- patient reported group
- description
- 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.
- interventionNames
- Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
- type
- ACTIVE_COMPARATOR
- label
- non-reported group
- description
- 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)
- interventionNames
- Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available