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CTRI Number  CTRI/2026/01/101489 [Registered on: 19/01/2026] Trial Registered Prospectively
Last Modified On: 15/01/2026
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Patient-Reported Outcome Measures (PROMs) in patients with oral cancer 
Scientific Title of Study   Implementation of Patient-Reported Outcome Measures (PROMs) in Patients Undergoing Oral Cancer Surgery 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Burhanuddin Qayyumi 
Designation  Assistant Professor 
Affiliation  Homi Bhabha Cancer Hospital and Research Centre 
Address  OPD No 203, Division of Head and Neck Oncology, Department of Surgical Oncology, HBCH&RC

Muzaffarpur
BIHAR
842004
India 
Phone  9566170436  
Fax    
Email  qburhan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Burhanuddin Qayyumi 
Designation  Assistant Professor 
Affiliation  Homi Bhabha Cancer Hospital and Research Centre 
Address  OPD No 203, Division of Head and Neck Oncology, Department of Surgical Oncology, HBCH&RC


BIHAR
842004
India 
Phone  9566170436  
Fax    
Email  qburhan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Burhanuddin Qayyumi 
Designation  Assistant Professor 
Affiliation  Homi Bhabha Cancer Hospital and Research Centre 
Address  OPD No 203, Division of Head and Neck Oncology, Department of Surgical Oncology, HBCH&RC


BIHAR
842004
India 
Phone  9566170436  
Fax    
Email  qburhan@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Centre Research Administration Council 
 
Primary Sponsor  
Name  Tata Memorial Centre Research Administration Council 
Address  Dr. E Borges Road, Parel, Mumbai - 400 012 India 
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 Burhanuddin Qayyumi  Homi Bhabha Cancer Hospital & Research Centre  Uma Nagar, Rasulpur, SKMCH Campus, Muzaffarpur(Bihar)-842004 India
Muzaffarpur
BIHAR 		 9566170436

qburhan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Homi Bhabha Cancer Hospital & Research Centre  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C021||Malignant neoplasm of border of tongue, (2) ICD-10 Condition: C020||Malignant neoplasm of dorsal surface of tongue, (3) ICD-10 Condition: C049||Malignant neoplasm of floor of mouth, unspecified, (4) ICD-10 Condition: C039||Malignant neoplasm of gum, unspecified, (5) ICD-10 Condition: C004||Malignant neoplasm of lower lip, inner aspect, (6) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (7) ICD-10 Condition: C059||Malignant neoplasm of palate, unspecified, (8) ICD-10 Condition: C003||Malignant neoplasm of upper lip, inner aspect, (9) ICD-10 Condition: C022||Malignant neoplasm of ventral surface of tongue,  
 
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  All patients with histologically proven oral squamous cell carcinoma, with plans for surgery with or without adjuvant therapy for oral cancer.

Patients will be enrolled within a month of diagnosis, and the first PROM will be assessed the night before surgery. 
 
ExclusionCriteria 
Details  Patients with cognitive impairments to whom the content of questionnaires cannot be adequately explained. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feasibility of PROMs in routine clinical practice based on recruitment and retention.  8 months after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess clinician’s perception of clinical benefit to patients in terms of intervention-based decisions made after completion of PROMs  2 months 
To assess patient and caregiver acceptability  8 months 
To identify reasons for discontinuation  8 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/02/2026 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [qburhan@gmail.com].

  6. For how long will this data be available start date provided 01-03-2027 and end date provided 01-03-2028?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
India has the highest number of oral cancer cases worldwide, accounting for one-third of the global total. Though better surgical and chemo-radiation protocols have improved disease related outcomes, the debilitating effect of these therapeutic interventions continue to have a negative impact on the patients’ quality of life (QoL) , in terms of altered taste and mastication, swallowing and speech impairment, cosmetic disfigurement, restricted mouth opening, mucositis, weight loss, cachexia, depression and anxiety
Symptom monitoring via patient-reported outcome measures (PROMs) offers an evidence-based approach to detecting symptoms which can provide critical information to clinicians, thereby improving clinical management. PROMs can also be used to foster communication between patients and clinicians, help facilitate an optimal rehabilitative program and improve QoL.
Problem Statement – What we cannot assess, we cannot address.
PROMs are currently being recorded only for patients enrolled in clinical trials at our tertiary cancer centre in Muzaffarpur, Bihar. Early identification of the major concerns our patients are facing through PROMs might improve patient -clinician communication and allow us to provide multidisciplinary interventions if indicated. However, integration of PROMs into our existing system will be resource intensive and may cause additional stress on both patients and clinicians. Therefore, it is essential to establish that all invested partners are on board before implementing the same.
 
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