| CTRI Number |
CTRI/2024/03/064193 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
12/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
PROSPECTIVE OBSERVATIONAL STUDY |
| Study Design |
Other |
|
Public Title of Study
|
Evaluating the Health-Related Quality of Life in patients undergoing definitive management for Head and Neck Squamous Cell Carcinoma |
|
Scientific Title of Study
|
Assessment of Health-Related Quality of Life (HR-QoL) of Patients During Definitive Management of Head and Neck Squamous Cell Carcinoma |
| 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 Advait Bhuran |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room no 405, OPD 4A, Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur-342005.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8369558530 |
| Fax |
|
| Email |
bhuranadvait@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vidhu Sharma |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room no 411, OPD 4A, Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur-342005.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
09816165999 |
| Fax |
|
| Email |
vidhusharma88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Advait Bhuran |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences Jodhpur |
| Address |
Room no 405, OPD 4A, Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur-342005.
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8369558530 |
| Fax |
|
| Email |
bhuranadvait@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Jodhpur |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences Jodhpur, Basini Phase-II, Jodhpur, Rajasthan-342005 |
| Type of Sponsor |
Government medical college |
|
|
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 Advait Bhuran |
All India Institute of Medical Sciences Jodhpur |
Room no 405, OPD 4A, Department of Otorhinolaryngology, All India Institute of Medical Sciences, Jodhpur-342005.
Jodhpur
RAJASTHAN |
08369558530
bhuranadvait@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTINAL ETHICS COMMITTEE AIIMS JODHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C029||Malignant neoplasm of tongue, unspecified, (2) ICD-10 Condition: C148||Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx, (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: C059||Malignant neoplasm of palate, unspecified, (6) ICD-10 Condition: C109||Malignant neoplasm of oropharynx,unspecified, (7) ICD-10 Condition: C119||Malignant neoplasm of nasopharynx,unspecified, (8) ICD-10 Condition: C12||Malignant neoplasm of pyriform sinus, (9) ICD-10 Condition: C139||Malignant neoplasm of hypopharynx,unspecified, (10) ICD-10 Condition: C099||Malignant neoplasm of tonsil, unspecified, (11) ICD-10 Condition: C069||Malignant neoplasm of mouth, unspecified, (12) ICD-10 Condition: C089||Malignant neoplasm of major salivary gland, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing definitive treatment (surgery followed by adjuvant radiotherapy/chemoradiation or definitive radiotherapy/ chemoradiation) for Head and Neck Squamous Cell Carcinoma at AIIMS Jodhpur |
|
| ExclusionCriteria |
| Details |
Patients undergoing only surgery as a part of definitive treatment
Patients undergoing palliative treatment
Patients who have taken treatment at other centers
Patients with recurrent disease
Patients who do not consent to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Health related Quality of life of patients during Definitive management of Head and Neck Squamous cell carcinoma at AIIMS Jodhpur |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Short term factors influencing health related quality of life |
1 year |
| Pattern of change in different domains of quality of life during treatment |
1 year |
| Factors affecting discontinuation of treatment |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
22/03/2024 |
| 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 Yet Recruiting |
| 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
|
Different domains of HRQoL are affected differently at various times of treatment and hence it needs further evaluation to provide the right kind of support. By synthesizing and critically analyzing the available evidence, this study seeks to identify the most affected domains of HRQoL at various time-points of treatment. Furthermore, the research aims to explore the factors influencing HRQoL in HNSCC patients and investigate the potential impact of different treatment modalities on their well-being. The findings from this study will contribute to a deeper understanding of the HRQoL challenges faced by patients with HNSCC and inform healthcare providers in tailoring personalized care plans. Ultimately, this research endeavors to enhance the quality of life for individuals living with HNSCC and foster a patient-centered approach that encompasses not only clinical outcomes but also the holistic well-being of those affected by this devastating disease.
|