| CTRI Number |
CTRI/2024/10/076084 [Registered on: 30/10/2024] Trial Registered Prospectively |
| Last Modified On: |
29/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Prevalence of depression and anxiety and their characteristics in patients diagnosed with cancer |
|
Scientific Title of Study
|
Prevalence of depression and anxiety and their characteristics in patients diagnosed with cancer : a cross sectional study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raman chopra |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur Uttar Pradesh 242307 |
| Address |
Department of Psychiatry Varun Arjun Medical College and Rohilkhand Hospital Banthra Shahjahanpur Uttar Pradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
08264948934 |
| Fax |
|
| Email |
ramanchopra5000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Alexander Martin Alphonse |
| Designation |
Professor and Head of Department of Psychiatry |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P |
| Address |
Department of Psychiatry Varun Arjun Medical College and Rohilkhand Hospital Banthra Shahjahanpur Uttar Pradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9820123848 |
| Fax |
|
| Email |
talentsondisplay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Alexander Martin Alphonse |
| Designation |
Professor and Head of Department of Psychiatry |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, U.P |
| Address |
Department of Psychiatry Varun Arjun Medical College and Rohilkhand Hospital Banthra Shahjahanpur Uttar Pradesh
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9820123848 |
| Fax |
|
| Email |
talentsondisplay@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of psychiatry , Varun Arjun Medical College and Rohilkhand Hospital , Banthra , shahjahanpur , Uttar Pradesh , India 242307 |
|
|
Primary Sponsor
|
| Name |
Dr. Raman chopra |
| Address |
Department of psychiatry Varun Arjun Medical College and Rohilkhand Hospital Banthra Shahjahanpur Uttar Pradesh |
| Type of Sponsor |
Other [self] |
|
|
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 Raman chopra |
Rohilkhand Medical College & Hospital |
Department of Surgery, Rohilkhand Cancer Institue , onco-surgery ward
Bareilly
UTTAR PRADESH |
08264948934
ramanchopra5000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Rohilkhand medcial College And Hospital , Bareilly , Uttar Pradesh India , 243006 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients diagnosed with cancer .
Patients willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Individuals with a prior history of substance abuse or addiction EXCEPT tobacco .
Subjects below 18 years of age.
Patients currently receiving treatment for psychiatric conditions that may impact the study outcomes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The study under consideration is for determining the prevalence of depression and anxiety in patients diagnosed with cancer. This is an observational study and no intervention is being carried out on study subjects. The outcome, as such, is the frequency of subjects having symptoms of anxiety and depression after administration of psychometric scales and/or questionnaires at the completion of the study. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
10/11/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Introduction: The study is titled "Prevalence of Depression and Anxiety and Their Characteristics in Patients Diagnosed with Cancer: A Cross-Sectional Study." It addresses the mental health challenges, particularly anxiety and depression, often faced by cancer patients, impacting their treatment outcomes. Previous studies have shown varying prevalence rates of depression in cancer patients, influenced by cancer type, disease stage, and treatment phase. Understanding these mental health issues is crucial for enhancing patient care and improving their quality of life. Aim and Objectives: - Aim: The primary aim is to determine the prevalence of depression and anxiety and their characteristics among cancer patients.
- Primary Objective: To assess the prevalence and characteristics of depression and anxiety in cancer patients.
- Secondary Objective: To examine the impact of these conditions on the quality of life of cancer patients.
Materials and Methods: - Study Design: This is a cross-sectional study.
- Study Setting: The study will take place at Rohilkhand Cancer Institute, Bareilly, Uttar Pradesh.
- Participants: Patients aged 18 years and above, diagnosed with cancer, willing to participate in the study.
- Sample Size: A total of 50 participants will be recruited through purposive sampling.
- Exclusion Criteria: Individuals with a history of substance abuse (except tobacco) and those receiving psychiatric treatment that may impact study outcomes are excluded.
- Data Collection Tools: The study uses the Hospital Anxiety and Depression Scale (HADS), WHO-QoL Bref for quality of life assessment, and a semi-structured proforma for socio-demographic data.
- Procedure: Patients meeting the criteria will be recruited, informed consent will be obtained, and a detailed history and clinical examination will follow. Anxiety and depression will be assessed using the HADS, and quality of life will be evaluated using WHO-QoL Bref.
- Analysis Plan: SPSS version 27.0 will be used for statistical analysis. Relationships between QoL scores and anxiety/depression will be analyzed, with a p-value < 0.05 considered significant.
Summary of Procedure: The study involves identifying eligible patients, obtaining informed consent, and conducting interviews to gather detailed demographic and clinical data. The tools for assessing depression, anxiety, and quality of life will be applied, followed by data organization and statistical analysis to determine prevalence and relationships between variables. The findings will guide the development of tailored treatment plans for cancer patients suffering from depression and anxiety. |