FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/081037 [Registered on: 20/02/2025] Trial Registered Prospectively
Last Modified On: 26/03/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Mixed method convergent parallel design 
Study Design  Other 
Public Title of Study   The time needed for seeking healthcare in patients receiving palliative intent intravenous therapy 
Scientific Title of Study   Time toxicity of patients with advanced malignancies receiving palliative intravenous systemic therapy - a multicenter observational study (GiveMeTIME) 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sharada Mailankody 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No. 5, Department of Medical Oncology, Fourth floor, Shirdi Sai Cancer Hospital Block, Madhavnagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922779  
Fax    
Email  sharada.m@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sharada Mailankody 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No. 5, Department of Medical Oncology, Fourth floor, Shirdi Sai Cancer Hospital Block, Madhavnagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922779  
Fax    
Email  sharada.m@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sharada Mailankody 
Designation  Associate Professor 
Affiliation  Kasturba Medical College, Manipal 
Address  Room No. 5, Department of Medical Oncology, Fourth floor, Shirdi Sai Cancer Hospital Block, Madhavnagar, Manipal

Udupi
KARNATAKA
576104
India 
Phone  08202922779  
Fax    
Email  sharada.m@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical College, Madhav Nagar, Manipal, Karnataka, India 576104 
 
Primary Sponsor  
Name  Indian Council of Medical Research 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911Ansari Nagar, New Delhi - 110029, India Phone: 91-11-26588895 / 91-11-26588980 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasanth Ganesan   JIPMER   Department of Medical Oncology, Jawaharlal Institute of Postgraduate Medical Education and Research, Dhanvantri Nagar, Gorimedu, Puducherry - 605006
Pondicherry
PONDICHERRY 		 9444216310

pg1980@gmail.com 
Dr Sharada Mailankody  Kasturba Medical College, Manipal  Room No. 5, Department of Medical Oncology, Fourth floor, Shirdi Sai Cancer Hospital Block, Madhavnagar, Manipal
Udupi
KARNATAKA 		 08202922779

sharada.m@manipal.edu 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, JIPMER   Approved 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  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  99.00 Year(s)
Gender  Both 
Details  1) Patients with advanced cancer
2) Expected survival of less than 1 year
3) Planned for palliative chemotherapy/systemic therapy 
 
ExclusionCriteria 
Details  1) Patients already on palliative IV chemotherapy/ immunotherapy for more than one month
2) Patients unable to provide informed consent or complete study procedures including questionnaire
3) Patients with Eastern Cooperative Oncology Group performance status (ECOG PS) 3
4) Terminally ill patients who are planned only for best supportive care
5) Patients less than 18 years
6) Patients planned for only oral therapy
7) Patients with hematological malignancies 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Time toxicity index   3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Correlation of Tt with QoL, financial toxicity and survival and develop a metric for incremental time toxicity  3 months for all parameters except survival which will be updated at 6 months, 9 months and 12 months  
 
Target Sample Size   Total Sample Size="224"
Sample Size from India="224" 
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)   05/03/2025 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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   The concept of time toxicity in cancer care is an often-neglected aspect of the significant time commitment demanded of patients undergoing treatment. While advancements in survival outcomes are pivotal, comprehending and quantifying the repercussions of time invested in cancer care are significant to patients with limited life-expectancy. “Time toxicity” includes diverse elements, including coordinating care, frequent visits to healthcare facilities (involving travel and wait times), and addressing side effects through urgent or emergent care, hospitalizations, and follow-up tests. These components collectively contribute to the overall burden of time devoted to pursuing cancer-directed therapy. Also, it is critical that the time spent on these activities can be substantial and, in certain instances, might outweigh the modest gains in survival offered by specific treatments. In addition to the medical and time-related considerations in cancer care, the financial aspect also plays a significant role in the overall impact of treatments on patients. While the providers commonly discuss side effects and medical costs associated with cancer therapy, the financial burden extends beyond direct medical expenses. It includes indirect costs that contribute to the overall financial toxicity. Patients and their families often face considerable financial challenges related to their cancer treatment, such as high out-of-pocket expenses for medications, co-pays for medical visits, and costs associated with supportive care and managing treatment-related side effects. Additionally, the indirect costs, including lost wages due to time away from work, transportation expenses for frequent visits to healthcare facilities, and the potential need for additional caregiving support, further contribute to the financial strain experienced by patients and their families. The time toxicity and financial toxicity associated with cancer care can have profound consequences on a patient’s quality of life, affecting their ability to meet basic needs, adhere to treatment plans, and maintain overall well-being. It may even influence treatment decisions also. Understanding the attitudes of oncologists, patients and caregivers regarding the relation of time toxicity to the relative gain in QoL and survival time is also important to understand different priorities. To address the financial and time-related aspects of cancer care, it is essential to integrate a comprehensive approach that considers both the direct and indirect implications on patients. 
Close