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CTRI Number  CTRI/2025/11/098043 [Registered on: 25/11/2025] Trial Registered Prospectively
Last Modified On: 24/11/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Observational – Prospective – Mixed Methods (Quantitative and Qualitative) 
Study Design  Other 
Public Title of Study   A study to understand what patients with advanced oral cancer and their caregivers expect from treatment. 
Scientific Title of Study   Understanding Patients and Caregivers expectations on the Treatment for Advanced Oral Cancer: A Prospective Mixed-Methods Study. (UPTAKE Study) 
Trial Acronym  UPTAKE STUDY 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr ShivaKumar Thiagarajan 
Designation  Professor, Head and Neck Oncology E, MS (ENT), DNB 
Affiliation  Tata Memorial Hospital 
Address  1209 Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai. Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  thiagarajans@tmc.gov.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Shivakumar Thiagarajan  
Designation  Professor, Head and Neck Oncology E, MS (ENT), DNB 
Affiliation  Tata Memorial Hospital 
Address  1209 Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai. Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  thiagarajans@tmc.gov.in  
 
Details of Contact Person
Public Query  
Name  Dr Shivakumar Thiagarajan  
Designation  Professor, Head and Neck Oncology E, MS (ENT), DNB 
Affiliation  Tata Memorial Hospital 
Address  1209 Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernest Borges Marg, Parel, Mumbai. Mumbai Maharashtra 400012 India

Mumbai
MAHARASHTRA
400012
India 
Phone  9846572399  
Fax    
Email  thiagarajans@tmc.gov.in  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra.  
 
Primary Sponsor  
Name  Tata Memorial Hospital 
Address  Dr. Ernest Borges Marg, Parel,Mumbai 400012,India Phone 9122-24177000, Extn.6656.  
Type of Sponsor  Other [Investigator Initiated Study] 
 
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 Shivakumar Thiagarajan  Tata Memorial Hospital  Dept of Head and Neck surgical Oncology (OPD) (2nd floor Homi bhabha block and 107 golden jublee block) parel mumbai Dr. Ernest Borges Marg Parel, Office 02224177000 EXTN.6656 Mumbai Maharashtra
Mumbai
MAHARASHTRA 		 9846572399

thiagarajans@tmc.gov.in  
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  -For Cohort 1_Group A: Newly diagnosed patients diagnosed with advanced (Stage III and IV) OSCC and their caregivers who are planned to receive curative-intent treatment or have completed treatment for advanced OSCC.
-For Cohort 2_Group B: patients diagnosed with advanced (Stage III and IV) OSCC and their caregivers who have completed treatment within a year.
-For Cohort 3_Group C: patients diagnosed with advanced (Stage III and IV) OSCC and their caregivers who have completed treatment greater than 1 year.
-Aged greater than or equal 18 years.
-Willing to provide informed consent.
 
 
ExclusionCriteria 
Details  -Patients with recurrent or metastatic disease.
-Patients unfit for adjuvant therapy.
-Cognitive or psychiatric conditions limiting their ability to participate in interviews.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To explore and analyse the patient’s and caregiver’s expectations of treatment outcomes for advanced OSCC  -Pre-therapy: After diagnosis but before initiation of treatment
-Post-therapy (short-term): Within one year after completion of therapy
-Post-therapy (long-term): More than one year after completion of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
-To explore if the priorities change across time points.
oPre-therapy (after cancer has been diagnosed but before therapy has begun)
oPost-therapy, short-term (within the first year after the end of therapy)
oPost-therapy, long-term (for survivors who have been living at least three years without relapses after therapy)
-To identify factors influencing patient expectations, such as socio-demographic background, prior knowledge, & healthcare provider communication.
-To explore emotional, psychological, & social concerns related to treatment & recovery.
 		 -Pre-therapy: After diagnosis but before initiation of treatment
-Post-therapy (short-term): Within 1 year after completion of therapy
-Post-therapy (long-term): More than 1 year after completion of therapy
-During data analysis: After completion of data collection for all three time points (for triangulation & comparison)

 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
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)   08/12/2025 
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="2"
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 mixed methods study aims to understand the expectations of patients with advanced oral squamous cell carcinoma and their caregivers regarding treatment outcomes, quality of life, and recovery. The study will explore how these expectations evolve over different time points of treatment and follow up, including before therapy, within one year after completion of therapy, and more than one year after treatment. Quantitative data will be collected using validated questionnaires such as the Treatment Expectation Questionnaire (TEX Q) and the International Classification of Functioning, Disability and Health Core Set for Head and Neck Cancer (ICF HNC) priorities checklist. Qualitative data will be obtained through semi structured interviews with patients and caregivers to explore emotional, psychological, and social concerns. The findings will help identify key expectations and gaps between expected and actual experiences, thereby improving patient centered communication and shared decision making in the management of advanced oral cancer. The study hypothesis is that patient and caregiver expectations vary across the course of treatment and are influenced by sociodemographic and communication factors. 
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