| CTRI Number |
CTRI/2024/03/064878 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of Risk factors of suicidal thoughts in oral cancer patients.
|
|
Scientific Title of Study
|
Assessment of risk factors of suicidal ideation in oral and maxillofacial cancer patients of Nagpur region: An analytical 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 |
Dr Pawan Motghare |
| Designation |
Assistant Professor |
| Affiliation |
VSPM Dental College & Research Centre Nagpur |
| Address |
Room No : 01, Department of Oral Medicine & Radiology, VSPM Dental College & Research Centre, Hingna Road, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822710845 |
| Fax |
|
| Email |
pawan_shivam1@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pawan Motghare |
| Designation |
Assistant Professor |
| Affiliation |
VSPM Dental College & Research Centre Nagpur |
| Address |
Room No 01 Department of Oral Medicine & Radiology, VSPM Dental college and Research Centre Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822710845 |
| Fax |
|
| Email |
pawan_shivam1@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pawan Motghare |
| Designation |
Assistant Professor |
| Affiliation |
VSPM Dental College & Research Centre Nagpur |
| Address |
Room no 01, Department of Oral Medicine & radiology, VSPM Dental college and Research centre, Hingna Road, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9822710845 |
| Fax |
|
| Email |
pawan_shivam1@yahoo.com |
|
|
Source of Monetary or Material Support
|
| VSPM Dental college and research center nagpur |
|
|
Primary Sponsor
|
| Name |
Dr Pawan Motghare |
| Address |
Room No 01, Department of Oral Medicine and Radiology,VSPM dental college and research centre, Hingna Rd, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019 |
| Type of Sponsor |
Other [self funded] |
|
|
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 Pawan Motghare |
VSPM Dental College and Research Centre |
Room no 01, Department of Oral Medicine and Radiology, Hingna Road, Digdoh Hills, Police Nagar, Nagpur, Digdoh, Maharashtra 440019
Nagpur
MAHARASHTRA |
9822710845
pawan_shivam1@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee VSPM Dental college and research center nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C068||Malignant neoplasm of overlappingsites of other and unspecified parts of mouth, (2) ICD-10 Condition: K137||Other and unspecified lesions of oral mucosa, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Oral and maxillofacial Cancer patients in any stage |
|
| ExclusionCriteria |
| Details |
1. Patients who decline to participate in the study
2. Patients with disturbance of consciousness, mental retardation, dementia and patients with
history of serious mental disorders - as these patients may experience barriers to
communication during the study. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Identifying the risk factors associated with suicidal ideation among patients with oral and maxillofacial cancer. This could involve examining various factors such as demographic characteristics, clinical variables (such as cancer stage and treatment modalities), psychological factors, social support, and any other relevant variables that could potentially contribute to suicidal ideation in this patient population. |
Assessing suicidal ideation at various stages of the cancer patients journey. This could include:
1. During Diagnosis
2.During Treatment (surgery/chemotherapy/radiotherapy/combination)
3. Post treatment
4. Longterm survivorship |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| not applicable |
not applicable |
|
|
Target Sample Size
|
Total Sample Size="138"
Sample Size from India="138"
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)
|
01/05/2024 |
| 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="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
|
Even though most of the research on suicidal ideation, attempts, and completed among cancer
patients has been conducted in developed countries, little attention is given to it in low and
middle-income and developing countries including India.
The presence of suicidal ideation with oral cancer may produces complications with the
treatment of cancer that can lead to poor adherence with treatment, worsening of the condition,
and affect quality of life. It can also tend to make people unknowingly end their lives and
increases mortality from the diseases.
Suicide rates among cancer patients are generally thought to be twice as high as that of the
general population. However, patients with oral cancer are at much higher risk for suicide;
patients may also be more at risk at certain times during their oral cancer trajectory. Although
high prevalence of oral cancer patients in India, no efforts has taken to identify the factors
which are provocative for suicidal ideation. This is the neglected aspect in such populations in
India on contrary to developed countries. This grave concern needs to be attended and for
identifying risk factors and intervening on time which can be a life saver for oral cancer
patients.
Suicidal Ideation among Oral cancer patients and factors contributing to it is not yet established
in Indian Population. Therefore, this study is designed to assess the risk factors for suicidal
ideation in Oral and maxillofacial cancer patients in Nagpur region.
Research question or hypothesis Primary Research Question
What are the risk factors of suicidal ideation in oral and maxillofacial cancer patients of Nagpur
region.? Null Hypothesis: There is no significant association between the assessed risk factors and suicidal ideation in
oral and maxillofacial cancer patients of Nagpur region. Alternate Hypothesis: There is significant association between the assessed risk factors and suicidal ideation in oral
and maxillofacial cancer patients of Nagpur region.
Aim and Objectives Aim of the study: To assess various risk factors of suicidal ideation in Oral and maxillofacial cancer patients of
Nagpur region. Primary Objectives of the study 1. To identify demographic factors contributing to suicidal ideation in oral and maxillofacial
cancer patients in Nagpur region. 2. To assess the impact of oral and maxillofacial cancer related factors and treatment modalities
on suicidal ideation in Nagpur region. 3. To assess the psychological distress and psychosocial variables on the occurrence of suicidal
thoughts of oral and maxillofacial cancer patients in Nagpur region.
Secondary Objective of the study 1. To estimate the prevalence of suicidal ideation in oral and maxillofacial cancer patients
in Nagpur region. |