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CTRI Number  CTRI/2025/09/094007 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 29/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Study of anxiety and depression in cancer patients: A cross-sectional study at rural hospital of central India.  
Scientific Title of Study   Study of anxiety and depression in cancer patients: A cross-sectional study at rural hospital of central India. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  TANYA 
Designation  Junior Resident 
Affiliation   
Address  Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, 442004.

Wardha
MAHARASHTRA
442004
India 
Phone  9972082229  
Fax    
Email  tanyatanya078@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Priyanka Yadav 
Designation  Associate Professor, Department of Psychiatry 
Affiliation   
Address  Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, 442004.

Wardha
MAHARASHTRA
442004
India 
Phone  9972082229  
Fax    
Email  dr.yadavpriyanka@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Tanya 
Designation  Junior Resident 
Affiliation   
Address  Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, 442004.

Wardha
MAHARASHTRA
442004
India 
Phone  9972082229  
Fax    
Email  tanyatanya078@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, 442004. 
 
Primary Sponsor  
Name  Jawaharlal Nehru Medical College Sawangi Wardha Maharashtra  
Address  Jawaharlal Nehru Medical College Sawangi Wardha Maharashtra 442004 
Type of Sponsor  Private medical college 
 
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 
Tanya  Jawaharlal Nehru Medical College and Acharya Vinoba Bhave Rural Hospital  Jawaharlal Nehru Medical College, Sawangi, Wardha, Maharashtra, 442004.
Wardha
MAHARASHTRA 
9972082229

tanyatanya078@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
DATTA MEGHE INSTITUTE OF HIGHER EDUCATION AND RESEARCH   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: F322||Major depressive disorder, singleepisode, severe without psychotic features, (2) ICD-10 Condition: F430||Acute stress reaction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  PATIENTS WHO ARE CLINICALLY DIAGNOSED TO HAVE CANCER EITHER BENIGN OR MALIGNANT BASED ON PATHOLOGICAL LAB FINDINGS AND CLINICAL SYMPTOMS.
PATIENTS WHO ARE READY TO GIVE WRITTEN INFORMED CONSENT 
 
ExclusionCriteria 
Details  SUBJECTS NOT WILLING TO GIVE WRITTEN INFORMD CONSENT
PATIENTS WHO WERE ALREADY SUFFERRING FROM ANXIETY AND DEPRESSION BEFORE BEING DIAGNOSED AS CANCER PATIENTS 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Through this study we will be able to study about the presence of anxiety and depressive disorder in patients diagnosed with cancer clinically and pathologically.  40 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
AT THE END OF STUDY WE WILL BE ABLE TO ASCERTAIN THE PREVALENCE OF ANXIETY AND DEPRESSION IN CANCER PATIENTS 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
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)   11/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  11/09/2025 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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  

The intricate interplay between oncology and mental health has emerged as a paramount facet of comprehensive patient care. Neoplastic disorders not only exert a deleterious impact on the physiological state but also has considerable influence over the emotional well-being of affected individuals. Of particular interest is the exploration of the prevalence of anxiety and depression within the distinct cancers patients.

Cancer, being an entity of considerable clinical and psychosocial complexity, mandates a thorough examination of its mental health consequences for family planning, and personal maturation, rendering a cancer diagnosis is keen and demanding. Anxiety and depression, recognized psychiatric sequela, warrant specific attention due to their potential to significantly impact the overall quality of life for cancer patients.

Anxiety and depressive disorders are highly prevalent in the general population, with an estimated 264 million people globally (3.6% of the global population) living with depression and 322 million (4.4% of the global population) living with anxiety in 2015.1 In recent years, the incidence and prevalence of both disorders has rapidly increased, with an estimated additional 53.2 million [95% confidence interval (CI) 44.8-62.9 million] cases of major depressive disorder and 76.2 million (95% CI 64.3-90.6 million) cases of anxiety disorder globally in 2020, compared with precoronavirus disease (COVID)-19 pandemic levels.2 The burden from these diseases is becoming an increasingly important worldwide problem.3 Major depression, or depression alone, is estimated to be the primary cause of disability, ahead of cardiovascular diseases and cancer itself.

This cross-sectional study attempts to methodically inspect the prevalence of anxiety and depression in individuals diagnosed with  neoplasms . By adopting a cross-sectional design, we intend to capture a singular temporal approach, affording insights into the immediate psychopathological landscape of this demographic. Diagnostic assessments and statistical analyses will be employed to investigate the psychosocial dynamics operative in this patient population.

The outcomes of this investigation hold promise in contributing evidence-based perspectives to the discipline of psycho-oncology and confronting the dual challenges of malignancy and psychological distress.

Subsequent sections of this report will explicate the methodological approach, delineate the results, and expound upon the implications, culminating in a nuanced synthesis of findings that stands to enrich the interface of oncology and psychiatry.The evaluation of depression and anxiety in patients with cancer is crucial for understanding the psychological state and also considerable influence over the emotional well-being of afflicted individuals and how it relates to psychopathology and quality of life while researching this issue.

 
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