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
|
|
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
|
|
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. |