| 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
|
|
|
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
|
|
|
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 |