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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03093649

Enrollment

320

Registered

2017-03-28

Start date

2017-07-31

Completion date

2019-05-31

Last updated

2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Neoplasms

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.

Interventions

OTHERadverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire

The intervention was administrated through APP

OTHERdo not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire

patients receive normal care and visit

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Score of physical functioning in quality of life	within 1 week of study completion	Score of physical functioning in quality of life

Secondary

Measure	Time frame	Description
3-year progression-free survival	3 year after diagnosis	progression-free 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
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
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
completion rate	within 1 week of study completion	completion rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026