| 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
|
|
|
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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Oral cancer patients who undergone surgery, |
|
|
Intervention / Comparator Agent
|
|
|
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. |