Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001095853
Ethics application status
Approved
Date submitted
11/10/2012
Date registered
12/10/2012
Date last updated
12/10/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research of quality of life in patients with laryngocarcinoma after different treatment methods
Scientific title
Accessing quality of life in patients with laryngocarcinoma after different treatment methods by means of the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30), Head and Neck Quality of Life Questionnaire (EORTC QLQ-H&N35), and Voice Handicap Index (VHI)
Secondary ID [1] 281374 0
Nil
Universal Trial Number (UTN)
U1111-1135-0391
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
laryngeal carcinomas 287600 0
Condition category
Condition code
Cancer 287933 287933 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
1.The patients with laryngeal cancer and ended treatment at least 6 months will be recruited (use the methods of self evaluation and telephone follow-up )in our research,and they need to fill in The Chinese versions of the European Organization for the Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and Head and Neck Quality of Life Questionnaire (EORTCQLQ-H&N35)and Voice Handicap Index(VHI). We also collecting general information and medical record so that we can analyse the effective factor and predict patient quality of life .We will stop recruiting until collect enough cases (expected to be 200 cases).
2.Comparing the QOL of patients through different treatment (e.g.partial laryngectomy, irradiation as primary therapy, laryngectomy, laryngectomy and radiotherapy ) then , discuss the pros and cons of every treatment methods aimed to help doctors find out the most suitable one considering the characteristics of different patients.
Intervention code [1] 285853 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288141 0
QOL of patients after total laryngectomy and with radiotherapy will be measured using the global EORTC QLQ-C30 and the head- and neck-specific EORTC QLQ-H&N35.

The general EORTC QLQ-C30: consists of 30 questions and incorporates five functional domains (physical, role, cognitive, emotional, and social), three symptom scales (fatigue, pain, and nausea/vomiting), a global health status, and a number of single items assessing additional symptoms.
The head and neck specific module EORTC QLQ-H&N35 :consisting of 35 further questions divided into seven multiple-item symptom scales assessing pain, swallowing, senses (taste and smell), speech, social eating, social contact and sexual-ity and six symptom items (teeth problems, trismus, dry mouth,sticky saliva, cough, and feeling ill).
Timepoint [1] 288141 0
one year after ended treatment.
Primary outcome [2] 288142 0
Score of the EORTC QLQ-C30 and QLQ-H&N35 filled by patients after all kinds of partial laryngectomy . Then we analysis what kind of operation to get higher QOL.
Timepoint [2] 288142 0
at 6 months after ended treatment
Secondary outcome [1] 299493 0
Voice ability of postoperative laryngeal cancer patients accessed by Voice Handicap Index(VHI).
Timepoint [1] 299493 0
6 months after ended treatment
Secondary outcome [2] 299494 0
Effect of radiotherapy on patients, accessed by symptom scales of EORTC QLQ-H&N35.
Timepoint [2] 299494 0
Radiotherapy after more than six months
Secondary outcome [3] 299495 0
Changes of QOL in patients wich different length of postoperative period (<1year, 1-2year , 3-5year, >5year)
Timepoint [3] 299495 0
6 months after ended treatment
Secondary outcome [4] 299496 0
Show the correlation of QOL scores and the different stages of cancer, with the correlation analysis method
Timepoint [4] 299496 0
6 months after ended treatment

Eligibility
Key inclusion criteria
1, Informed consent of patients.
2, After surgical resection or radiation treatment of laryngeal cancer patients.
3,Patients had the ability to read,understand,and answer questionnaires.
4, Ended the treatment for more than half a year, in good condition at present.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1, past and current mental illness patients and consolidation of the heart, lungs and other major disorders.
2, Recent relapses.
3, can not understand the contents of the questionnaire or do not wish to take part in

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
27/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 4592 0
China
State/province [1] 4592 0
China - Guangdong

Funding & Sponsors
Funding source category [1] 286126 0
University
Name [1] 286126 0
Young Faculty Cultivation Project of Sun Yat-sen University (10ykpy10)
Country [1] 286126 0
China
Funding source category [2] 286127 0
Government body
Name [2] 286127 0
the National Natural Science Foundation of China (81072224),
Country [2] 286127 0
China
Funding source category [3] 286128 0
Government body
Name [3] 286128 0
Science and Technology Planning Project of Guangdong Province(2009B030801109)
Country [3] 286128 0
China
Primary sponsor type
Individual
Name
Lei wenbin
Address
Zhong shan 2nd Road 58,
Guangzhou 510080
Country
China
Secondary sponsor category [1] 284940 0
Individual
Name [1] 284940 0
Wen weiping
Address [1] 284940 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 284940 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288176 0
Institutional Review Board of the First Affiliated Hospital of Sun Yat-sen University
Ethics committee address [1] 288176 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Ethics committee country [1] 288176 0
China
Date submitted for ethics approval [1] 288176 0
27/08/2012
Approval date [1] 288176 0
Ethics approval number [1] 288176 0

Summary
Brief summary
There are many therapies for Laryngeal cancer, such as laryngectomy, irradiation as primary therapy, laryngectomy, laryngectomy and radiotherapy, the choice of treatment between them is being influenced increasingly by the expected voice quality and quality of life (QoL).This study we use three validated questionnaires: Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and Head and Neck Quality of Life Questionnaire (EORTCQLQ-H&N35)and Voice Handicap Index(VHI).for evaluated patient’s QOL after surgery or radiotherapy treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34814 0
Address 34814 0
Country 34814 0
Phone 34814 0
Fax 34814 0
Email 34814 0
Contact person for public queries
Name 18061 0
Lei wenbin
Address 18061 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 18061 0
China
Phone 18061 0
0086-20-87333733
Fax 18061 0
0086-20-87333733
Email 18061 0
[email protected]
Contact person for scientific queries
Name 8989 0
Lei wenbin
Address 8989 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 8989 0
China
Phone 8989 0
0086-20-87333733
Fax 8989 0
0086-20-87333733
Email 8989 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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