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

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.

Study Overview

• Status: Unknown
• Conditions: Nasopharyngeal Neoplasms
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patient reported group; 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; The intervention was administrated through APP
Active Comparator: non-reported group; 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; patients receive normal care and visit

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2017
• Primary Completion (Anticipated): May 1, 2019
• Study Completion (Anticipated): May 1, 2019

Study Registration Dates

• First Submitted: March 16, 2017
• First Submitted That Met QC Criteria: March 22, 2017
• First Posted (Actual): March 28, 2017

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 22, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Nasopharyngeal Carcinoma; Nasopharyngeal Neoplasms
• Other Study ID Numbers: 2017-FXY-003-放疗科

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No