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

Sun Yat-sen University1 site in 1 country320 target enrollmentJuly 2017

ConditionsNasopharyngeal Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nasopharyngeal Neoplasms
Sponsor: Sun Yat-sen University
Enrollment: 320
Locations: 1
Primary Endpoint: Score of physical functioning in quality of life
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2017

End Date

May 2019

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sun Yat-sen University

Responsible Party

Principal Investigator

Ying Sun

principal investigator

Sun Yat-sen University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Score of physical functioning in quality of life

Time Frame: within 1 week of study completion

Score of physical functioning in quality of life

Secondary Outcomes

completion rate(within 1 week of study completion)
3-year progression-free survival(3 year after diagnosis)
3-year metastatic-free survival(3 year after diagnosis)
3-year overall survival(3 year after diagnosis)
3-year local-regional free survival(3 year after diagnosis)
degrees of patients satisfaction regarding the treatment process(within 1 week of study completion)
response rate(1 month after study completion)