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

Nasopharyngeal Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03093649
• Other study ID #: 2017-FXY-003-???
• Status: Not yet recruiting
• Phase: N/A
• First received: March 16, 2017
• Last updated: March 22, 2017
• Start date: July 2017
• Est. completion date: May 2019

Study information

• Verified date: March 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nasopharyngeal Neoplasms

Intervention

Other:
• adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
The intervention was administrated through APP
• 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

Locations

Country	Name	City	State
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score of physical functioning in quality of life	Score of physical functioning in quality of life	within 1 week of study completion
Secondary	3-year overall survival	overall survival at three year after diagnosis	3 year after diagnosis
Secondary	3-year progression-free survival	progression-free survival at three year after diagnosis	3 year after diagnosis
Secondary	3-year local-regional free survival	local-regional free survival at three year after diagnosis	3 year after diagnosis
Secondary	3-year metastatic-free survival	metastatic-free survival at three year after diagnosis	3 year after diagnosis
Secondary	completion rate	completion rate	within 1 week of study completion
Secondary	degrees of patients satisfaction regarding the treatment process	degrees of patients satisfaction regarding the treatment process	within 1 week of study completion
Secondary	response rate	response rate	1 month after study completion