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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03093649
Other study ID # 2017-FXY-003-???
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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