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CTRI Number  CTRI/2023/08/056958 [Registered on: 25/08/2023] Trial Registered Prospectively
Last Modified On: 23/05/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA)
Process of Care Changes
Behavioral 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Geriatric assessment based interventions in older patients with cancer 
Scientific Title of Study   Impact of Geriatric assessment- based intervention on Health-Related Quality of life of older patients with cancer 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nidhi Soni 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  3095A, Third Floor, Teaching Block

South
DELHI
110049
India 
Phone  8527118534  
Fax    
Email  nidhisoni1962@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nidhi Soni 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  3095A, Third Floor, Teaching Block

South
DELHI
110049
India 
Phone  8527118534  
Fax    
Email  nidhisoni1962@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nidhi Soni 
Designation  Assistant Professor 
Affiliation  AIIMS 
Address  3095A, Third Floor, Teaching Block

South
DELHI
110049
India 
Phone  8527118534  
Fax    
Email  nidhisoni1962@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of Medical sciences, New Delhi 
 
Primary Sponsor  
Name  AIIMS 
Address  Ansari Nagar, New Delhi 
Type of Sponsor  Research institution and hospital 
 
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 Nidhi Soni  All India Institute of Medical sciences  3095A, Third floor, Teaching Block
South
DELHI 
8527118534

nidhisoni1962@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics committee for biomedical and health research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D498||Neoplasm of unspecified behavior of other specified sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  geriatric assessment based personalised interventions  An intervention plan will be formed on the basis of geriatric assessment results and recommended interventions would be initiated, along with the standard care from medical oncology department 
Comparator Agent  Standard of care  Patients will be given their baseline Geriatric assessment results with no interventions by the multidisciplinary team (MDT) and send to the oncology for their standard treatment.  
 
Inclusion Criteria  
Age From  65.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Patients age more than 65 years with a diagnosis of solid malignant neoplasm of any stage, ECOG 0-2, able to give written informed consent, treatment naïve older patients with cancer
 
 
ExclusionCriteria 
Details  Patient denying participation, ECOG 3 and 4, hematological malignancies
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in HRQoL by Global health status scale of EORTC QLQ C-30  At baseline and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
change in other HRQoL parameters on EORTC QLQ C-30 & FACT-G at 3 & 6 months
Overall survival at 1 year
Chemotherapy related toxicity
Changes in CAF and IGF-1 biomarker at 6 months 
3,6 & 12 months 
 
Target Sample Size   Total Sample Size="170"
Sample Size from India="170" 
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 3/ Phase 4 
Date of First Enrollment (India)   01/09/2023 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
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
Modification(s)  

Indian population is aging with increased percentage of older age population. This further increases the prevalence of chronic, non-communicable diseases, of which malignancies are one. Two important aims of treatment in older patients with cancer are increasing survival and improving their health-related quality of life (HRQoL). The management of older cancer population is challenging in view of increased number of comorbidities and increased age-related issues, which can be assessed by comprehensive geriatric assessment. Previous studies have shown that with time HRQoL changes in these patients and baseline quality of life (QoL) parameters are better prognostic markers than other clinical variables. It has been seen in multiple studies that multidisciplinary interventions improve HRQoL scores, but other studies have shown conflicting results with conflicting effect on survival. While patient’s communication and satisfactions seemed to improve, with these interventions. But these interventions and their results were not uniform in the studies. 

With the hypothesis that geriatric assessment (GA) based personalized interventions will improve the HRQoL of the older patients with cancer, this study has been planned. Other objectives would be to observe the impact of these interventions on survival, toxicity of the treatment, patient satisfaction, muscle mass and strength, and molecular levels. This study would be done in treatment naïve patients with solid malignancies to maintain homogeneity. In this prospective randomized two group comparative study, patient would be divided in two groups, of which one would be given GA based personalized interventions by the multidisciplinary team (planned by the investigator) and then would be send to the medical oncology team for standard of care treatment. While the other group would undergo geriatric assessment and with the results would be send to medical oncology team for standard of care, and further referrals to super-specialty would be decided by treating oncologist. These patients would be followed for one year to observe their survival, patient satisfaction, treatment toxicity, muscle mass and strength and change in biomarker levels. 

 
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