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CTRI Number  CTRI/2025/02/081423 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   prospective observational study 
Study Design  Other 
Public Title of Study   Tracking Function in Bone Pain Patients Using Barthels Index  
Scientific Title of Study   Assessing the change in Functional status in patients with Metastatic Bone Pain using Barthels Index in Outpatient Specialist Palliative Clinic in Tertiary Cancer Hospital in India : Prospective Observational 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 Raghu S Thota  
Designation  Professor  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  Palliative Medicine OPD , Room no. 75 ,Main Building , Tata Memorial Hospital ,Dr Ernest Borges Road , Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769077764  
Fax    
Email  ragstho24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Raghu S Thota  
Designation  Professor  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  Palliative Medicine OPD , Room no. 75 ,Main Building , Tata Memorial Hospital ,Dr Ernest Borges Road , Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769077764  
Fax    
Email  ragstho24@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Raghu S Thota  
Designation  Professor  
Affiliation  TATA MEMORIAL HOSPITAL 
Address  Palliative Medicine OPD , Room no. 75 ,Main Building , Tata Memorial Hospital ,Dr Ernest Borges Road , Parel, Mumbai

Mumbai
MAHARASHTRA
400012
India 
Phone  9769077764  
Fax    
Email  ragstho24@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital , Dr Ernest Borges road , Parel, Mumbai , 400012 ,Maharashtra , India 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasun P  ACTREC  Sector 22, Utsav Chowk - CISF Rd, Owe Camp, Kharghar, Navi Mumbai, Maharashtra 410210, India.
Raigarh
MAHARASHTRA 		 9870450187

drprasunprem@gmail.com 
Dr Raghu Thota  Tata Memorial Hospital  Room no. 75 Palliative Medicine, Ground floor, Main Building, Tata Memorial Hospital, E Borges Road, Parel Mumbai - 400012, Maharashtra, India.
Mumbai
MAHARASHTRA 		 9769077764

ragstho24@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee - II  Approved 
Institutional Ethics Committee - II  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 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  1. Newly registered patients in Palliative Care OPD.
2. Histopathologically confirmed malignancy.
3. Advanced cancer with metastatic bone pain.
4. Communicates in English or Hindi and provides written consent.  
 
ExclusionCriteria 
Details  1. Follow-up patients.
2. Unstable conditions needing emergency care.
3. Psychiatric/cognitive impairments.
4. Non-cancer-related pain.
5. Experimental/non-standard treatments.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the change in the Barthel Index score from baseline to 2 weeks in patients with metastatic bone pain receiving Palliative care.  To assess the change in the Barthel Index score from baseline to 2 weeks in patients with metastatic bone pain receiving Palliative care. 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the change in pain intensity in patients with metastatic bone pain on palliative care  baseline to 2 weeks 
To evaluate change in overall QOL in patients with metastatic bone pain on palliative care  baseline to 2 weeks 
To document current patterns of management in patients with metastatic bone pain  baseline to 2 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/03/2025 
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="1"
Months="0"
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   This prospective observational study evaluates the impact of standard palliative care on functional status in patients with metastatic bone pain using the Barthel Index. Conducted at Tata Memorial Hospital, it aims to measure changes in daily activity levels, pain intensity, and quality of life over two weeks. The study includes adults with advanced cancer and metastatic bone pain who can communicate in English or Hindi and excludes follow-up patients, those with unstable conditions, psychiatric impairments, non-cancer pain, or experimental treatments. Findings will guide improvements in palliative care for better patient outcomes. 
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