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CTRI Number  CTRI/2023/12/060654 [Registered on: 21/12/2023] Trial Registered Prospectively
Last Modified On: 24/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [TELEMONITORING]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Telemedicine in pain management among cancer patients 
Scientific Title of Study   Assessment of the feasibility of implementation of telemedicine for pain management among cancer patients in a tertiary care hospital, PUDUCHERRY- A pragmatic Randomized controlled trial. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kusumkali Das 
Designation  Junior Resident 
Affiliation  JIPMER 
Address  JIPMER Dhanvantari Nagar
NIL
Pondicherry
PONDICHERRY
605006
India 
Phone  8116484704  
Fax    
Email  ikusumkali@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  GUNASEELAN K 
Designation  Professor 
Affiliation  JIPMER 
Address  JIPMER Dhanvantari Nagar
NIL
Pondicherry
PONDICHERRY
605006
India 
Phone  9362966444  
Fax    
Email  gunapgi@gmail.com  
 
Details of Contact Person
Public Query  
Name  MAHALAKSHMY T 
Designation  Additional Professor 
Affiliation  JIPMER 
Address  JIPMER Dhanvantari Nagar
NIL
Pondicherry
PONDICHERRY
605006
India 
Phone  9488729774  
Fax    
Email  mahalakshmi.dr@gmail.com  
 
Source of Monetary or Material Support  
JIPMER,Pondicherry 
 
Primary Sponsor  
Name  KUSUMKALI DAS 
Address  JIPMER Dhanvantari Nagar 
Type of Sponsor  Other [Self] 
 
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 Gunaseelan K  Jawaharlal Institute of Postgraduate Medical Education and Research  RCC Department of Radiation oncology JIPMER Dhanvantari Nagar Pondicherry
Pondicherry
PONDICHERRY 		 04132298288

hospitaloffice@jipmer.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER Institutional Ethics Committee Interventional studies   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  TELEMONITORING   Telemonitoring pain status with weekly voice or video calls along with routine OPD visit 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.Biopsy proven or clinically diagnosed cancer of any sites who are registered in the palliative care unit for pain and supportive care
2.life expectancy >2 months
3.Availability of necessary equipment for the video or voice consultation.
4.Availability of the care-giver for patients with poor health status or those unfamiliar with technology .
5.Ability to use the platform.
6.patient’s NRS score between 4-7 for at least a period of more than 14 days. 
 
ExclusionCriteria 
Details  Presence of moderate and severe cognitive, visual and hearing impairment of any malignant or non-malignant cause. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Patients adherence to pain management schedule.
2. Feasibility of implementation of telemedicine in pain management. 		 4 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
QoL
Patients satisfaction with their supportive care.
Trend of pain with NRS and PFI. 		 4 weeks 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
Final Enrollment numbers achieved (Total)= "170"
Final Enrollment numbers achieved (India)="170" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/01/2024 
Date of Study Completion (India) 24/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 24/08/2025 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response (Others) -  NIL

  4. For what types of analyses will this data be available?
    Response (Others) -  NIL

  5. By what mechanism will data be made available?
    Response (Others) -  NIL

  6. For how long will this data be available start date provided 14-01-2025 and end date provided 15-01-2029?
    Response (Others) -  NIL

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 170 patients with any biopsy proven or clinically diagnosed malignancy registered in the Palliative care of unit JIPMER will be recruited after taking consent considering the inclusion and exclusion criteria. Participants will be randomly allocated into two arms-intervention and control arm.  In the beginning of study both arms participants will go through a baseline evaluation of pain status and quality of life and the supportive care they are receiving through multiple questionnaires like-BPI,EQ-5D-5L and detailed drug history will be taken.  In the intervention arm participants will be followed up with weekly voice or video calls for 4 weeks along with monthly routine OPD visits and during the telemonitoring  their pain status and detailed drug history  will be taken through a semi-structured proforma. In the control arm only monthly routine OPD visits will be done, no telemonitoring. After completion of 4th week participants  from both arms will be re-evaluated for their pain status and quality of life and the supportive care with detailed drug history through all previously used  questionnaire like- BPI,EQ-5D-5L and along with these, their adherence to treatment schedule will also be evaluated in the end of the study  with a semi-structured proforma .Also participants satisfaction with their mode of treatment which includes telemonitoring follow up  with telehealth usability questionnaire. Collected data analysis with be done with content analysis and SPSS software. 
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