| CTRI Number |
CTRI/2024/10/075922 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessing the prevalence of Cancer pain in a Higher Cancer Centre |
|
Scientific Title of Study
|
Cancer Pain Prevalence: A Prospective study at a Regional/Quarternary Cancer Centre |
| 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 Poorna M S |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Department of Anesthesia, Pain and Palliative care, Cancer Institute (WIA), Sardar Patel road, Adyar, Chennai
Cancer Institute (WIA), Sardar Patel road, Adyar, Chennai, Tamil Nadu, 600020
Chennai
TAMIL NADU
600020
India |
| Phone |
9916053879 |
| Fax |
|
| Email |
poorna.ms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR POORNA M S |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
Roon no. 10, Department of Anesthesia,Pain and Palliative care, Cancer Institute (WIA), Sardar Patel road, Adyar, Chennai
Cancer Institute(WIA) Sardar Patel road, Adyar, Chennai, Tamil Nadu, 600020
Chennai
TAMIL NADU
600020
India |
| Phone |
9916053879 |
| Fax |
|
| Email |
poorna.ms@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR POORNA M S |
| Designation |
Assistant Professor |
| Affiliation |
Cancer Institute (WIA) |
| Address |
room no. 10, Department of Anesthesia, Pain and Palliative care, Cancer Institute (WIA), Sardar Patel road, Adyar, Chennai
Depart of Anesthesia,Pain and Palliative care, Sardar Patel road, Adyar, Chennai, Tamil Nadu, 600020
Chennai
TAMIL NADU
600020
India |
| Phone |
9916053879 |
| Fax |
|
| Email |
poorna.ms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cancer Institute (WIA), Sardar Patel road, Adyar, Chennai 600020 |
| The Pain questionnaire BPI Brief Pain Inventory, MD Anderson Cancer centre, Texas, USA |
|
|
Primary Sponsor
|
| Name |
the Director, Cancer Institute (WIA) |
| Address |
Sardar Patel road, Adyar, Chennai, TN 600020 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrPoornaMS |
Cancer Institute (WIA) |
Cancer Institute (WIA),Sardar Patel road, Adyar, Chennai, TN 600020
Chennai
TAMIL NADU |
9916053879
poorna.ms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee - NABH accredited |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C801||Malignant (primary) neoplasm, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All adult patients coming to Cancer Institute (WIA) with oncological ailment |
|
| ExclusionCriteria |
| Details |
paediatric patients, Patients with history of surgery within past 30 days, Patients with history of psychiatric disorder, Patients presenting to Emergency department, Patients unable to comprehend the questions
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| to estimate the prevalence of cancer related pain in patients presenting to Cancer Institute over 1 month |
30 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
– to determine the type and severity of cancer pain in various typed of cancer.
- to assess the effectiveness of the current analgesic practice in place. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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)
|
01/12/2024 |
| 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="0"
Months="2"
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
|
All patients coming to Cancer Institute (WIA)
over the period of 30 days irrespective of the visitation number will be given
the self-administered questionnaire to be answered during the time of
registration.
The questionnaire will consist of 9 questions
describing their pain.
Patients will fill the questionnaire on any 1
visit only. They need not repeat the form in the subsequent visits in this 30 day trial
BSc Anesthesia
technician student and one social worker will be
data collection investigator – he/she will be trained by the team to help
patient with comprehension and translation of the questionnaire
The study will be overseen and assessed by the
investigators with intermittent audit to check for authenticity of the data
collected by the student |