Nasopharyngeal NeoplasmsNCT03093649
Measuring Patient-Reported Adverse Events in Oncology Practice Improves Quality of Life in Nasopharyngeal Carcinoma
A study testing adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire and do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Neoplasms
- What is being tested?
- adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire and do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- Jul 2017to May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Nasopharyngeal Neoplasms
- Being tested
- 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
- Medical subject headings
- Nasopharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaireOther
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) questionaireOther
patients receive normal care and visit
| Study group | Role | What they receive |
|---|---|---|
| patient reported group | Experimental | 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. Receives: Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire |
| non-reported group | Active comparator | 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) Receives: Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score of physical functioning in quality of life
Score of physical functioning in quality of life
Measured: within 1 week of study completion
Secondary outcomes (7)
3-year overall survival
overall survival at three year after diagnosis
Measured: 3 year after diagnosis
3-year progression-free survival
progression-free survival at three year after diagnosis
Measured: 3 year after diagnosis
3-year local-regional free survival
local-regional free survival at three year after diagnosis
Measured: 3 year after diagnosis
3-year metastatic-free survival
metastatic-free survival at three year after diagnosis
Measured: 3 year after diagnosis
completion rate
completion rate
Measured: within 1 week of study completion
degrees of patients satisfaction regarding the treatment process
degrees of patients satisfaction regarding the treatment process
Measured: within 1 week of study completion
response rate
response rate
Measured: 1 month after study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study startJul 2017 (estimated)
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Sun, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093649
- Sponsor's protocol ID
- 2017-FXY-003-放疗科
- Status last verified
- Mar 2017
- First submitted
- 16 Mar 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03093649
- Acronym / sponsor ID
- 2017-FXY-003-放疗科
- Conditions
- Nasopharyngeal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jul 2017 (estimated)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 28 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient reported group | Experimental | Other: adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionairePatients 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. |
| non-reported group | Active comparator | Other: do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionairePatients in this group received normal care during the treatment without completing patient reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaireThe intervention was administrated through APP | Other | patient reported group |
| do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionairepatients receive normal care and visit | Other | non-reported group |
Primary outcome
Score of physical functioning in quality of life
Time frame: within 1 week of study completion
Score of physical functioning in quality of life
7 secondary outcomes
3-year overall survival
Time frame: 3 year after diagnosis
3-year progression-free survival
Time frame: 3 year after diagnosis
3-year local-regional free survival
Time frame: 3 year after diagnosis
3-year metastatic-free survival
Time frame: 3 year after diagnosis
completion rate
Time frame: within 1 week of study completion
degrees of patients satisfaction regarding the treatment process
Time frame: within 1 week of study completion
response rate
Time frame: 1 month after study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire and do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire in people with Nasopharyngeal Neoplasms, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score of physical functioning in quality of life (time frame: within 1 week of study completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.