| CTRI Number |
CTRI/2024/07/071079 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
27/07/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Delayed Presentation of Cancer in India - Analyzing the time lags and the underlying knowledge, attitude and beliefs |
|
Scientific Title of Study
|
Delayed Presentation in Cancer (DEPRICA) |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankita Mehta |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, 576104, India |
| Address |
Room No 7
Department of Radiotherapy and Oncology
Manipal Comprehensive Cancer Care Centre
Udupi
KARNATAKA
576104
India |
| Phone |
08398874330 |
| Fax |
|
| Email |
ankita.mehta@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankita Mehta |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, 576104, India |
| Address |
Room No 7
Department of Radiotherapy and Oncology
Manipal Comprehensive Cancer Care Centre
Udupi
KARNATAKA
576104
India |
| Phone |
08398874330 |
| Fax |
|
| Email |
ankita.mehta@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ankita Mehta |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, 576104, India |
| Address |
Room No 7
Department of Radiotherapy and Oncology
Manipal Comprehensive Cancer Care Centre
Udupi
KARNATAKA
576104
India |
| Phone |
08398874330 |
| Fax |
|
| Email |
ankita.mehta@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Manipal, Udupi, 576104, India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL FUNDING REQUIRED FOR THIS TRIAL] |
|
|
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 Ankita Mehta |
Kasturba Medical College, Manipal, Udupi |
Room No 7, Department of Radiotherapy & Oncology, Manipal Comprehensive Cancer Care Centre
Udupi
KARNATAKA |
8398874330
ankita.mehta@manipal.edu |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| KMC and KH Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C80||Malignant neoplasm without specification of site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with histologically confirmed diagnosis of cancer
2. Patients on any line of treatment who have been diagnosed in the past two years
3. Follow up patients treated within the last 6 months |
|
| ExclusionCriteria |
| Details |
1. Patient not bought to hospital.
2. Performance status ECOG 4.
3. Patients who are not fully conscious or mentally sound.
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Delays in presentation correlated with the baseline characteristics
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="343"
Sample Size from India="343"
Final Enrollment numbers achieved (Total)= "323"
Final Enrollment numbers achieved (India)="323" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/08/2024 |
| Date of Study Completion (India) |
27/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The written questionnaire will be
provided to participants that captures the timeline of events from symptom
presentation till diagnosis, the patient’s and caregivers perception and
knowledge of cancer, patient’s concerns towards treatment, and personal
characteristics including psychological beliefs, social behaviour and
personality type. The questionnaire has been validated by a group of expert
physicians comprising of oncologists, public health and palliative medicine
specialists. After starting accrual, the questionnaire will be validated on the
first twenty patients and necessary modifications will be done in the
questionnaire.
Patients and caregivers who
consent to participate will be provided the questionnaire form and asked to
tick/fill the appropriate responses. Those who cannot read/write or requiring
assistance will be interviewed and the responses will be entered by the
investigators in questionnaire form. Certain baseline factors
including (co-morbidity, family history, addiction history, primary disease
site) will be recorded from electronic database to reduce the time of
questionnaire.
The baseline patient characteristics
will be correlated with the delays at various steps. |