| CTRI Number |
CTRI/2025/10/096266 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
17/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Head and Neck Cancer: A Study on the Psychosocial and Financial Distress in Patients. |
|
Scientific Title of Study
|
Assessment of psychosocial and financial distress among patients with head and neck cancer. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Aashka Karkera |
| Designation |
Student |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7204203943 |
| Fax |
|
| Email |
aashkakarkera2004@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Uday Venkat Mateti |
| Designation |
Associate Professor |
| Affiliation |
NGSM Institute of Pharmaceutical Sciences |
| Address |
Department of Pharmacy Practice, NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8152977460 |
| Fax |
|
| Email |
udayv@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| Nitte (Deemed to be University), NGSM Institute of Pharmaceutical Sciences, Deralakatte, Mangaluru 575018 |
|
|
Primary Sponsor
|
| Name |
NGSM Institute of Pharmaceutical Sciences, NITTE (Deemed To Be University) |
| Address |
Deralakatte, Mangaluru 575018 |
| Type of Sponsor |
Other [Educational Institution] |
|
|
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 Vijith Shetty |
Justice K.S. Hegde Charitable Hospital |
Department of Oncology, Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA |
8861796017
drvijithshetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSGM Institute of Pharmaceutical Sciences Institutional Ethics Committee (NGSMIPS-IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-C14||Malignant neoplasms 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 above 18 years old.
2. Patients who have had at least 1 cycle of chemotherapy. |
|
| ExclusionCriteria |
| Details |
1. Newly diagnosed patients.
2. Critically sick adult cancer patients who were unable to respond and had no attendants during the data collection period.
3. Patients diagnosed with multiple malignancies or those other than HNC. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the financial and psychosocial distress among HNC patients. |
Outcome will be measured at baseline. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare financial & psychosocial distress scores between various factors. |
Outcome will be measured at baseline. |
| To find the relationship between financial & psychosocial distress. |
Outcome will be measured at baseline. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/11/2025 |
| 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="0"
Months="6"
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
|
INTRODUCTION Head and neck cancers (HNC) consists of a diverse group of cancers primarily affecting the nasal, oral, pharyngeal, laryngeal and upper oesophageal tract. Tobacco use and alcohol use are the well-established risk factors, alongside oncogenic viruses such as Epstein-Barr Virus and the human papilloma virus (HPV). HNC chiefly follows squamous histology which may affect multiple anatomical sites, leading to sequential malignant development. Unlike other cancers, HNC affects complex functional anatomy performing crucial responsibilities like vision, hearing, balance, olfaction, gustation, communication, endocrine and cosmesis. Impairment or visible disfigurement of the anatomy during the course of illness is known to distress HNC patients. The association of body-image perception to interpersonal relationships and social communication leads to altered psychosocial needs. Additionally, HNC utilizes complex multi-disciplinary procedures, spanning across histological examination, radiographic imaging, biopsies, surgery, radiotherapy and chemotherapy. An assessment of the psychosocial and financial aspects in HNC patients is essential in understanding the mental state of the patient and the financial impact of the disease. OBJECTIVES OF THE STUDY The study aims to assess the financial and psychosocial distress among HNC patients, find the relationship between financial and psychosocial distress and compare financial and psychosocial distress scores between various factors. METHODOLOGY This prospective study will be conducted at the Department of Oncology, Justice KS Hegde Hospital, Deralakatte, Mangaluru. The sample size is approximated to be 60 participants. Ethical approval will be obtained, and participants will provide written consent. The study will span 6 months from September 2025 to February 2026 and include all HNC patients above 18 years of age and have had at least 1 round of treatment, with certain exclusion such as newly diagnosed patients, critically sick adult cancer patients who were unable to respond and had no attendants during the data collection period and patients diagnosed with multiple malignancies or those other than HNC. FACIT-COST and Distress Thermometer will be used as measures of financial and psychosocial distress, respectively, for which permission has been obtained. STATISTICAL ANALYSIS Quantitative data will be expressed as Mean ± SD or Median (IQR). Qualitative data will be expressed as frequency and percentage. Spearman Rank Correlation/Pearson Correlation will be used to find the relationship between financial and psychosocial distress scores. Independent t-test/Mann-Whitney U test or one-way ANOVA/Kruskal-Wallis test will be used to compare the scores between selected features. Tukey post-hoc comparison test will be used for multiple comparisons. SPSS software version 29 will be used for statistical analysis.
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