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CTRI Number  CTRI/2018/01/011535 [Registered on: 24/01/2018] Trial Registered Retrospectively
Last Modified On: 24/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative 
Study Design  Other 
Public Title of Study   A study on quality of life among oral cancer survivors to know their experiences and needs following surgery in Madhya Pradesh  
Scientific Title of Study   Study on quality of life among oral cancer survivors following surgery in Madhya Pradesh 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samridhi Nigam 
Designation  Student 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health Manipal University Manipal- 576104 Karnataka, India
Manipal University Manipal- 576104 Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9981861583  
Fax    
Email  dr.samridhi91@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr P Arathi Rao 
Designation  Assistant Professor 
Affiliation  Prasanna School of Public Health 
Address  Prasanna School of Public Health Manipal University Manipal- 576104 Karnataka, India
Prasanna School of Public Health Manipal University Manipal- 576104 Karnataka, India
Udupi
KARNATAKA
576104
India 
Phone  9008418848  
Fax    
Email  arathimph@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Samridhi Nigam 
Designation  Student 
Affiliation  Manipal University 
Address  47, Swarnkar Colony Nigam Dental Hospital Vidisha Madhya Pradesh
47, Swarnkar Colony Nigam Dental Hospital Vidisha Madhya Pradesh
Vidisha
MADHYA PRADESH
464001
India 
Phone  9981861583  
Fax    
Email  dr.samridhi91@gmail.com  
 
Source of Monetary or Material Support  
Dr Samridhi Nigam 47, Swarnkar Colony Nigam Dental Hospital Vidisha - 464001 Madhya Pradesh,India 
 
Primary Sponsor  
Name  Dr Samridhi Nigam 
Address  47, Swarnkar colony Nigam Dental Hospital Vidisha Madhya Pradesh 
Type of Sponsor  Other [Private sponser] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Samridhi Nigam  Department of Head and Neck Cancer  Jawaharlal Nehru Cancer Hospital and Research Centre Idgah Hills Bhopal, Madhya Pradesh
Bhopal
MADHYA PRADESH 
07552665720
0755-2738325
dr.samridhi91@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Hospital, Manipal Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Oral cancer patients who undergone surgery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Patients those who are willing to participate and who had undergone surgery at least 3 months before irrespective of current mode of treatment.
 
 
ExclusionCriteria 
Details  Patients who are going through only chemotherapy or radiotherapy but not surgery. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The study will help to understand experiences and needs of oral cancer patient post-surgery based on life style, physical health, aesthetics, social-life, psychological needs and financial burden on them.
 
January 2018 to June 2018 
 
Secondary Outcome  
Outcome  TimePoints 
This study will give scope on designing interventions regarding improving the quality of life of oral cancer patient post-surgery through supportive and promotive health care.  January 2018 to June 2018 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "28"
Final Enrollment numbers achieved (India)="28" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/01/2018 
Date of Study Completion (India) 15/03/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   None Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Oral cancer is one of the highly prevalent cancers worldwide and is a leading cause of mortality especially in Southeast Asia region. Oral cancer ranks in the top three of all cancers in India, which accounts for over thirty percent of all cancers reported in the country. The International Agency for Research on Cancer has predicted that India’s incidence of cancer will increase from 1 million in 2012 to more than 1.7 million in 2035. Oral cancer is among the most common form of cancer seen in Madhya Pradesh. Oral cancer burden differs from other regions, mainly due to culturally determined practices of tobacco use and habitual chewing of carcinogenic substances like areca nut, pan masala, gutka etc. While these indicators provide critical information about the health status of populations but they do not offer any information about the quality of life of survivors. Increasing life expectancy from surgery in oral cancer also highlights the need for other measures of health, especially the quality of the years lived. This study will help to understand the burden of disease, experiences, needs and quality of life of patients who have undergone surgery and how they cope-up with the treatment. So that steps can be taken to design interventions regarding improving the quality of life of oral cancer patient post-surgery through supportive and promotive health care.

 

 
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