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EFFECT OF A COUNSELING AND REHABILITATION PROGRAM ON THE QUALITY OF LIFE OF HEAD AND NECK CANCER PATIENTS UNDERGOING CHEMORADIOTHERAPY(PILLAR project)

Phase 3
Not yet recruiting
Conditions
Malignant neoplasms of lip, oral cavity and pharynx,
Registration Number
CTRI/2019/09/021057
Lead Sponsor
AMERICAN SOCIETY OF CLINICAL ONCOLOGY
Brief Summary

The purpose of this research is to evaluate a dedicated & comprehensive supportive care and rehabilitation programme for patients with locally advanced head and neck cancers receiving chemoradiotherapy. Our hypothesis is based on the assumption that  integrating counseling and rehabilitation services with the  treatment will improve patient compliance and tolerance to chemoradiotherapy and will positively impact the treatment outcomes and quality of life of the  patients. Dedicated faculty will monitor the patients during the project and provide counseling on hygeine , nutrition, home made diets and   swallowing therapy to prevent dysphagia. The aims and objectives of this study are as below

1.     To evaluate theimpact of a structured counseling and rehabilitation programme on the qualityof life of patients

2. To evaluate theimpact of a structured counseling and rehabilitation program onchemoradiotherapy related treatment toxicity 3.    To evaluate theimpact of a structured counseling and rehabilitation programme on patientscompliance to treatment

Majority of our patients come from the economically weaker sections of society and are unaware of and also unable to afford dedicated supportive services.The research is designed to fill this lacunae in our patient care system for such patients.

Head and neck cancers is emerging as a important public health problem in our country with a huge burden of disease( 30% cancers in males and 4.8-15% cancers in females). The results of this study will help us improve our treatment protocols  keeping in mind the specific requirements of our  Indian patients and we propose  to provide counselling and rehabilitation services routinely to our patients in the near future by using the results of this pilot project to guide us.

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Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
170
Inclusion Criteria

Adult patients presenting with stage III-IVB head and neck cancers having a histopathological proof and with primaries in oral cavity, oropharynx and hypopharynx will be included in the analysis.

Exclusion Criteria

All post operative patients and those who have undergone prior chemoradiotherapy to head and neck will be excluded from the analysis.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To evaluate the impact of a structured counseling and rehabilitation programme on the quality of life of patientsONE YEAR
Secondary Outcome Measures
NameTimeMethod
1.To evaluate the impact of a structured counseling and rehabilitation programme on chemoradiotherapy related treatment toxicity2.To evaluate the impact of a structured counseling and rehabilitation programme on patients compliance to treatment

Trial Locations

Locations (1)

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH

🇮🇳

Chandigarh, CHANDIGARH, India

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
🇮🇳Chandigarh, CHANDIGARH, India
DR AMIT BAHL
Principal investigator
6283774431
dramitbahl@yahoo.com

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