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CTRI Number  CTRI/2021/04/033156 [Registered on: 27/04/2021] Trial Registered Prospectively
Last Modified On: 24/08/2021
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Qualitative Study 
Study Design  Other 
Public Title of Study   Improving access to pain relief in India 
Scientific Title of Study   Improving Appropriate Access and Availability of Opioids for Cancer-related Pain Control in India (IMPOP): bridging the gap between policy and practice  
Trial Acronym  IMPOP 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naveen Salins 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College 
Address  Department of Palliative Medicine and supportive care Kasturba Medical College Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  919969683669  
Fax    
Email  naveensalins@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Naveen Salins 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College 
Address  Department of Palliative Medicine and supportive care Kasturba Medical College Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  919969683669  
Fax    
Email  naveensalins@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Naveen Salins 
Designation  Professor and HOD 
Affiliation  Kasturba Medical College 
Address  Department of Palliative Medicine and supportive care Kasturba Medical College Manipal Karnataka

Udupi
KARNATAKA
576104
India 
Phone  919969683669  
Fax    
Email  naveensalins@gmail.com  
 
Source of Monetary or Material Support  
Kasturba Medical College MAHE 
 
Primary Sponsor  
Name  Kasturba Medical College 
Address  MAHE Manipal Udupi District 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Naveen Salins  Kasturba Medical College  Department of Palliative Medicine and Supportive Care Room no 4 Udupi District
Udupi
KARNATAKA 		 9969683669

naveen.salins@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  doctors, nurses, pharmacists service managers or other worker pertinent who are handling cancer related pain 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Doctors nurses pharmacists service managers or other worker pertinent to opioid use for cancer related pain.
Part of an Indian palliative care team where opioids are routinely used for cancer related pain
Able and willing to give informed verbal recorded consent to interview
Palliative care service self-reporting routine use of Morphine or other opioid annually for cancer related pain
 
 
ExclusionCriteria 
Details  Failure to meet inclusion criteria 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Key findings from our analysis of the interview data within four areas relevant to Good Practice (procurement, storage, prescribing and dispensing) will be organized into a Handbook, highlighting important steps necessary for ensuring safe availability of opioids within services, including necessary regulatory processes for opioid licensing, through to appropriate prescribing and dispensed.  6 months following study data collection completion ( 31st July 2021) 
 
Secondary Outcome  
Outcome  TimePoints 
A provisional Handbook will be presented to all co-investigators and appropriate amendments made. Once the study team have agreed the content of this Handbook first draft, we will invite key stakeholders in cancer care across India and regionally known to the study team and participants, to an expert consensus workshop to refine the Handbook for wider circulation
Once the Handbook has been finalised, we will hold a dissemination Workshop, to which key stakeholders will be invited.  		 1 year following study data collection completion (31st July 2021)  
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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   Phase 1 
Date of First Enrollment (India)   30/04/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Pending 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Most people with advanced-stage cancer experience moderate/severe pain which is treatable with opioid pain-killers. However, most people in India, with cancer live with, and die from it, without receiving these effective pain-killers.

We aim to interview key clinicians at three successful clinical teams in India, to find out how they have overcome problems to ensure safe and appropriate pain control for patients. We will synthesise good practice regarding procuring, storing, prescribing and dispensing of opioids for cancer-related pain within current regulations to produce a ‘Best Practice Handbook’, to discuss with other cancer services.

Underprivileged sections of Indian society are disproportionately affected by cancer and lack of access to pain treatment. Our project contributes to the National Health Protection Mission, 2018, to reduce inequalities in in outcomes for underprivileged members of Indian society and safely implement the Narcotic Drugs and Psychotropic Substances Act, 2014, to make opioids available for medical use.

 
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