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CTRI Number  CTRI/2025/10/096496 [Registered on: 27/10/2025] Trial Registered Prospectively
Last Modified On: 25/10/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Comprehensive intervention programme]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Intervention Program to Reduce Symptoms and Improve the Quality of Life of People with Head and Neck Cancer 
Scientific Title of Study   Effectiveness of Comprehensive Intervention Programme on Physiological and Psychological Symptoms and Quality of life among Patients with Head and Neck Cancer in a selected Tertiary care Hospital at Mangaluru. 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JYOTHI RAO 
Designation  Ph.D scholar 
Affiliation  Yenepoya deemed to be University 
Address  Department of medical surgical nursing, 5th floor,Room number-5 YENEPOYA NURSING COLLEGE,Naringana campus,DERALAKATTE
Department of medical surgical nursing,5th floor,Room number-5 YENEPOYA NURSING COLLEGE,Naringana campus,DERALAKATTE
Dakshina Kannada
KARNATAKA
575018
India 
Phone  7411821499  
Fax    
Email  jyothirao@yenepoya.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr.Binsha Pappachan C 
Designation  Professor,HOD, Mental Health Nursing 
Affiliation  Yenepoya deemed to be University 
Address  Department of Mental Health nursing,4th floor, room number-2 YENEPOYA NURSING COLLEGE,Naringana campus,DERALAKATTE
Department of Mental Health nursing,4th floor, room number-2 YENEPOYA NURSING COLLEGE,Naringana campus,DERALAKATTE
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9964340783  
Fax    
Email  binshadennis@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr. K.Jayapalan 
Designation  Senior Medical Physicist 
Affiliation  Yenepoya deemed to be University 
Address  Department of Radiation Oncology Basement-2, room number-1 Yenepoya Medical College Hospital Yenepoya,Deemed to be University
Department of Radiation Oncology Basement-2, room number-1 Yenepoya Medical College Hospital Yenepoya,Deemed to be University
Dakshina Kannada
KARNATAKA
575018
India 
Phone  9688945895  
Fax    
Email  nkjayapalan@yenepoya.edu.in  
 
Source of Monetary or Material Support  
Yenepoya medical college Hospital,Deralakatte,Mangaluru karnataka,India -pincode-575018 Self funded project 
 
Primary Sponsor  
Name  Nil 
Address  NA 
Type of Sponsor  Other [NA] 
 
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 
JYOTHI RAO  Yenepoya Medical College Hospital  Oncology department,7th floor,room number-4
Dakshina Kannada
KARNATAKA 		 07411821499

jyothirao@yenepoya.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee-II  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C00-D49||Neoplasms,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive intervention programme  Randomized controlled trial will evaluate the effectiveness of a Comprehensive Intervention Programme (CIP) compared to routine hospital care in patients with head and neck cancer. Intervention Group (CIP),Participants will receive a structured 15-day program including: Psycho education sessions: Conducted on Day 1 and Day 15, each lasting 30–45 minutes, addressing coping strategies, symptom management, and emotional support. Swallowing exercises: Eight specific techniques, performed three times daily with 5–10 repetitions each from Day 2 to Day 15, to improve swallowing function and reduce dysphagia.Yoga Nidra meditation: Daily sessions of 20–25 minutes from Day 2 to Day 15, designed to enhance relaxation and reduce psychological distress. 
Comparator Agent  Nil  Participants will receive routine hospital care according to standard hospital protocols. Information Booklet will be provided to the intervention group after the 3-month follow-up assessment; the control group will receive the booklet after the final 6-month post-assessment. Assessment Schedule: Baseline assessments will be conducted on Day 1. Follow-up assessments will be performed on Day 15, and at 1, 3, and 6 months post-intervention, using validated tools to evaluate dysphagia, xerostomia, fatigue, anxiety, depression, distress, and quality of life. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Head and neck cancer
Male and Female adults aged between 40 to 60years
Patients with stage two and three cancer
Patients receiving Radiation and Chemotherapy
 
 
ExclusionCriteria 
Details  With unconscious state.
Undergoing surgical treatment.
With visual/auditory impairment.
Ryle’s tube feeding
Dysphagia from a reason other than cancer
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in the physiological symptoms (Dysphagia, xerostomia and fatigue) ,psychological symptoms ( Anxiety, depression and distress) and quality of life  15thday,1month,3rdmonth and 6 month 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="136"
Sample Size from India="136" 
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)   10/11/2025 
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="3"
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 cancer (HNC) is a significant cause of morbidity and mortality worldwide, often resulting in debilitating physiological and psychological symptoms. Patients undergoing treatment for head and neck cancer may experience a range of challenges, including pain, fatigue, difficulty swallowing, speech issues, and psychological distress such as anxiety and depression. These symptoms can severely impact their quality of life (QoL). Comprehensive intervention programme includes a combination of psychological, and physical therapies, designed to address both the physical and emotional challenges faced by these patients. The aim of this study is to assess the Effectiveness of Comprehensive Intervention Programme on Physiological and Psychological Symptoms and Quality of life among Patients with head and neck cancer. The data will be collected from 136 patients with Head and Neck cancer. A randomized controlled design will be adopted for the study. Pre-test will be conducted for control and intervention Group, followed by intervention Group will receive Comprehensive intervention (Psycho education, Swallowing Exercise, and Yoga Nidra Meditation). Post Test will be conducted on 15th day, 1st Month, 3rd Month and 6thMonth. The collected data will be analyzed using descriptive and Inferential Statistics.

 
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