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CTRI Number  CTRI/2025/07/090319 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On: 03/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   LONGITUDINAL 
Study Design  Single Arm Study 
Public Title of Study   Patient Concerns Inventory 
Scientific Title of Study   Evaluation of Patient concerns using the Patients Concern Inventory (PCI) in Head Neck Radiation Oncology clinics: A longitudinal study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shwetabh sinha 
Designation  Assistant professor 
Affiliation  Tata memorial hospital 
Address  Department of Radiation Oncology, ACTREC, Kharghar Navi Mumbai 410210
Department of Radiation Oncology, Tata Memorial hospital, Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177262  
Fax  0  
Email  shwetabhsinha23@gmail.com   
 
Details of Contact Person
Scientific Query
 
Name  Dr Shwetabh sinha 
Designation  Assistant professor 
Affiliation  Tata memorial hospital 
Address  Department of Radiation Oncology, ACTREC, Kharghar Navi Mumbai 410210
Department of Radiation Oncology, Tata Memorial hospital Parel Mumbai 400012
Mumbai
MAHARASHTRA
400012
India 
Phone  02224177262  
Fax  0  
Email  shwetabhsinha23@gmail.com   
 
Details of Contact Person
Public Query
 
Name  Dr Sagar Suryawanshi 
Designation  Junior resident 
Affiliation  Tata memorial hospital 
Address  Department of Radiation Oncology, Tata Memorial hospital, Parel, Mumbai 400012

Mumbai
MAHARASHTRA
400012
India 
Phone  8433773778  
Fax    
Email  sagarsuryawanshi408@gmail.com  
 
Source of Monetary or Material Support  
Tata Memorial Hospital, Parel, Mumbai 400012, India 
 
Primary Sponsor  
Name  Tata Memorial Hospital  
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 = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shwetabh sinha  Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)  Room No.205D, 2nd floor, Paymaster Shodika, Kharghar Navi Mumbai 410210
Raigarh
MAHARASHTRA 
9470101936

shwetabhsinha23@gmail.com  
Dr Shwetabh sinha  Tata Memorial Hospital  OPD No. 206 2nd floor Homi Bhabha block, Dr. Ernest Borges Road, Parel, Mumbai 400012
Mumbai
MAHARASHTRA 
02224177262

shwetabhsinha23@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
TMC IEC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients with histologically proven head and Neck Cancer
2. Patients treated with Curative Intent
3. Patients willing to sign the Informed Consent Form.
4. Literate Adult patients who are able to understand either English or Hindi will be included in the study. 
 
ExclusionCriteria 
Details  1. Patients with synchronous or metachronous primaries or have received treatment for HN
cancers in the past.
2. Illiterate Patients who do not understand the PCI themselves.
3. Patients who do not sign the consent form
4. Patients who exclusively speak Marathi or other regional language and are unable to understand either English or Hindi. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To address the enumerated Concerns of patients coming for Radiation Oncology consultation/ treatment with a curative intent in Head and Neck Cancers using the Patients Concern Inventory (at diagnosis) module.  baseline, 3 months,6 months, 12 months  
 
Secondary Outcome  
Outcome  TimePoints 
To address the enumerated concerns of patients post treatment in head neck cancer patients using the PCI-HN post treatment module for a total duration of 1 year post treatment.  3 months,6 months, 12 months  
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   15/07/2025 
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  
Head and Neck Squamous Cell Carcinoma (HNSCC) is one of the most common types of cancer in
India. It often occurs in areas like the mouth, voice box, and throat. These cancers can show different
symptoms depending on their location. Globally, cases of these cancers are increasing, and by 2050, it is
expected that 35 million new cancer cases will be diagnosed annually—a 77 percent rise compared to 2023. In
India, HNSCC affects people differently than in Western countries due to factors like earlier onset,
specific causes, and healthcare challenges like poverty, late detection, and limited access to treatment.
Treating head and neck cancers is complex because they involve various areas that require
different approaches. Treatment often combines surgery, radiotherapy, and chemotherapy, along with
support from teams specializing in speech therapy, physical therapy, quitting smoking, and nutrition.
Advances in treatment have improved survival rates, but they also bring long-term side effects. Since
these cancers occur near critical body parts, treatments can affect basic functions like eating, speaking,
and appearance. Surgery might cause visible scars, difficulty swallowing or speaking, or the loss of body
parts. Radiation therapy can lead to dry mouth, dental issues, changes in taste, and stiffness in the neck.
These challenges can significantly impact the daily lives of patients and survivors.
Understanding the needs of head and neck cancer patients is essential to providing quality care
and improving their lives. Often, patients struggle to share their problems with doctors because they
feel shy, don’t want to complain, or fear being a burden. As a result, some issues remain unaddressed.
To solve this, a tool called the Patient Concerns Inventory (PCI) was developed. This is a list of 56
common concerns that patients can select before meeting their doctor. It helps ensure that important
issues are not overlooked and allows healthcare professionals to address these concerns effectively.
The PCI–HN (specifically designed for head and neck cancer patients) helps patients
communicate their needs better and gives them more control over their health concerns. It also allows
doctors to direct their consultations and make referrals to other specialists when needed.
This study aims to understand the concerns of head and neck cancer patients in our context—
both when they start treatment and during follow-ups. This information will help doctors improve the
quality of consultations and identify patients who need extra support.

AIM AND OBJECTIVES
1. We aim to use PCI in our set of Head neck cancer patients to identify patient concerns and
improve patient care.
2. OBJECTIVE 
2.1. Primary Objective: To document the concerns of patients coming for Radiation Oncology
consultations/ treatment for Head and Neck Cancers, at baseline and post treatment.
2.2. Secondary Objective:
A. To evaluate changes in their concerns during follow-up compared to their initial assessment.
B. To document any other concern (other than those mentioned in PCI) specific to Indian patients.
C. To personalize referrals for future patients using the PCI questionnaire
D. To measure prevalence of Return to Work amongst employed HNC patients and compare QoL
between those who RTW and those who do not RTW.

ENDPOINTS
1. PRIMARY ENDPOINT: To address the enumerated Concerns of patients coming for Radiation
Oncology consultation/ treatment with a curative intent in Head and Neck Cancers using the
Patients Concern Inventory (at diagnosis) module.
2. SECONDARY ENDPOINT: To address the enumerated concerns of patients post treatment in
head neck cancer patients using the PCI-HN post treatment module for a total duration of 1 year
post treatment.

STUDY DESIGN: Prospective longitudinal study to evaluate patient concerns using the Patients
Concern Inventory (PCI).

Inclusion Criteria: 1. Patients with histologically proven head and Neck Cancer
2. Patients treated with Curative Intent
3. Patients willing to sign the Informed Consent Form.
4. Literate Adult patients who are able to understand either English or Hindi will be included in
the study.

Exclusion Criteria: 1. Patients with synchronous or metachronous primaries or have received treatment for HN
cancers in the past.
2. Illiterate Patients who do not understand the PCI themselves.
3. Patients who do not sign the consent form
4. Patients who exclusively speak Marathi or other regional language and are unable to
understand either English or Hindi.

SAMPLE SIZE: To assess the longitudinal changes in patient concerns, we plan to enroll a convenient
sample of 300 individuals from head and neck Radiation Oncology clinics. 
 
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