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
Verified date | March 2017 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen University Cancer Center | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
China,
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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