Back to resultsMeasuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
Primary Purpose
Nasopharyngeal Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Sponsored by
About this trial
This is an interventional supportive care trial for Nasopharyngeal Neoplasms
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
Sites / Locations
- Sun Yat-sen University Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
patient reported group
non-reported group
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Score of physical functioning in quality of life
Score of physical functioning in quality of life
Secondary Outcome Measures
3-year overall survival
overall survival at three year after diagnosis
3-year progression-free survival
progression-free survival at three year after diagnosis
3-year local-regional free survival
local-regional free survival at three year after diagnosis
3-year metastatic-free survival
metastatic-free survival at three year after diagnosis
completion rate
completion rate
degrees of patients satisfaction regarding the treatment process
degrees of patients satisfaction regarding the treatment process
response rate
response rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03093649
Brief Title
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2017 (Anticipated)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Neoplasms
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
patient reported group
Arm Type
Experimental
Arm Description
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.
Arm Title
non-reported group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Other
Intervention Name(s)
adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Intervention Description
The intervention was administrated through APP
Intervention Type
Other
Intervention Name(s)
do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
Intervention Description
patients receive normal care and visit
Primary Outcome Measure Information:
Title
Score of physical functioning in quality of life
Description
Score of physical functioning in quality of life
Time Frame
within 1 week of study completion
Secondary Outcome Measure Information:
Title
3-year overall survival
Description
overall survival at three year after diagnosis
Time Frame
3 year after diagnosis
Title
3-year progression-free survival
Description
progression-free survival at three year after diagnosis
Time Frame
3 year after diagnosis
Title
3-year local-regional free survival
Description
local-regional free survival at three year after diagnosis
Time Frame
3 year after diagnosis
Title
3-year metastatic-free survival
Description
metastatic-free survival at three year after diagnosis
Time Frame
3 year after diagnosis
Title
completion rate
Description
completion rate
Time Frame
within 1 week of study completion
Title
degrees of patients satisfaction regarding the treatment process
Description
degrees of patients satisfaction regarding the treatment process
Time Frame
within 1 week of study completion
Title
response rate
Description
response rate
Time Frame
1 month after study completion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Sun Yat-sen University Cancer Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
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