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Clinical Trials/CTRI/2025/10/096496
CTRI/2025/10/096496
Not yet recruiting
Not Applicable

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.

Not provided1 site in 1 country136 target enrollmentStarted: November 10, 2025Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
136
Locations
1
Primary Endpoint
Reduction in the physiological symptoms (Dysphagia, xerostomia and fatigue) ,psychological symptoms ( Anxiety, depression and distress) and quality of life

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
None

Eligibility Criteria

Ages
40.00 Year(s) to 60.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 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.

Exclusion Criteria

  • With unconscious state.
  • Undergoing surgical treatment.
  • With visual/auditory impairment.
  • Ryle’s tube feeding Dysphagia from a reason other than cancer.

Outcomes

Primary Outcomes

Reduction in the physiological symptoms (Dysphagia, xerostomia and fatigue) ,psychological symptoms ( Anxiety, depression and distress) and quality of life

Time Frame: 15thday,1month,3rdmonth and 6 month

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

JYOTHI RAO

Yenepoya deemed to be University

Study Sites (1)

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