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CTRI Number  CTRI/2023/11/060153 [Registered on: 22/11/2023] Trial Registered Prospectively
Last Modified On: 21/12/2023
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Assessment of stigma and QoL in Cancer patients 
Scientific Title of Study   Assessment of stigma and QoL analysis in patients with Cancers of Breast, Head and Neck, Lungs: A hospital based prospective study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
SSH/StigmaQoL-2023/DrJKS  Other 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jitendra Kumar Singh 
Designation  Director and Senior Oncologist 
Affiliation  S S Hospital and Research Centre, Patna (INDIA) 
Address  Room No. 101, Department of Clinical Oncology SSHRC, Kankarbagh, Patna

Patna
BIHAR
800020
India 
Phone  9431021001  
Fax    
Email  drjksingh.onco@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mrs Parool Gupta 
Designation  Scientist-B and CRC (Clinical Trials Dept) 
Affiliation  S. S. Hospital and Research Institute, Patna 
Address  Room No. 201, Department of Clinical Trials/Research SSHRC, Kankarbagh, Patna

Patna
BIHAR
800020
India 
Phone  9431460063  
Fax    
Email  parool.icmr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Mr Sachidananda Behera 
Designation  Visiting Researcher (Scientist-B) 
Affiliation  S. S. Hospital and Research Centre, Patna 
Address  Romm No. 103, Department of Clinical Oncology, SSHRC, Kankarbagh, Patna

Patna
BIHAR
800020
India 
Phone  9430233378  
Fax    
Email  sachidananda.niper@gmail.com  
 
Source of Monetary or Material Support  
S. S. Hospital and Research Centre, Patna, PIN-8000020, Bihar 
 
Primary Sponsor  
Name  S S Hospital and Research Centre 
Address  Kankarbagh, Patna 
Type of Sponsor  Private hospital/clinic 
 
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 JK Singh   S S hospital and Research Centre, Patna  Room No. 102, Department of Clinical Oncology, SSHRC, Kankarbagh, Patna
Patna
BIHAR 
9431021001

drjksingh.onco@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
S S Hospital and Research Centre, Patna  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (3) ICD-10 Condition: C341||Malignant neoplasm of upper lobe,bronchus or lung,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  10.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  Diagnosed with Cancer of Breast, Head and Neck, Lungs
Willing to participate in the study
Should not have HIV/STDs, TB, several mental disorders
Should not be terminally ill 
 
ExclusionCriteria 
Details  Cancer patients with serious co-morbid conditions
Unwilling to participate
Patients with HIV/STDs, TB, COVID-19 infections
Terminally ill patients
Patients below 10 year and above 75 years age 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
We can find the factors associated with Cancer related stigma in selected patients and the data
of QoL will show the patients response in this study. 
2 years 
 
Secondary Outcome  
Outcome  TimePoints 
Essential support may be generated for palliative care of Cancer patients  1 year 
 
Target Sample Size   Total Sample Size="250"
Sample Size from India="250" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
Cancer is a deadly disease characterised by the development of abnormal and uncontrollable cell division. Solid cancers are one of the leading causes of cancer related deaths, characterized by rapid growth of tumour, and local and distant metastases. The cases of new diagnosed cancer in 2020 across the globe was 19.3 million and incidence of cancer case is higher in male (10,065,305) than female (9,227,484) according to GLOBOCAN data, 2020. Globally the major types of cancer include breast cancer, lungs cancer, cervical cancer, head and neck cancer, melanoma (skin cancer) etc. (WHO report, 2021). In India 1.15 million people diagnosed with cancer and 0.7 million people died in recent years (Pandey et al., 2019). It is predicted that, if effective diagnosis and treatment measures are not taken in time, then the national cancer burden in India will exceed 1 crore by 2030. The integrated efforts both from the Govt. and private sectors need to be accelerated for the timely and efficient management of this alarming disease. In Bihar, the low literacy rate and lack of advanced treatment facilities to all the cancer patients rushing in to hospital settings mark a serious issue in Eastern India. The World Health Organisation has defined two distinct but related strategies to promote the early detection of cancer, early diagnosis, that is, the recognition of symptomatic cancer at an early stage; and screening, that is the identification of asymptomatic disease in a target population of apparently healthy individuals. Despite of Govt. aid, the phobia of Cancer and societal as well as financial constraints cause delay or harm to the patients in India to receive proper medical treatment and palliative care. However, the data of cancer patients treated or being treated (along with the drug regimens and/or side effects, if any) in Bihar region remains largely unpublished. There is very limited data available for cancer cases in Eastern India because of which people are not so much aware of the increasing cancer prevalence and incidences. Many individuals do not know about the cause of cancers because it has not been made much educative to the people of Bihar. We aim to assess the cancer related stigma and QoL analysis in Cancer patients of Breast, Head and Neck, Lungs using WHO-QoL tools at S. S. Hospital and Research Centre, Patna
 
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