| 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
|
|
|
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
|
|
|
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. |