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Assessment of Quality of Life in Head and Neck Cancer Patients Using a New Tool Compared to an Existing Questionnaire

Development, Validation and Comparative Assessment of a Novel Comprehensive Quality of Life Instrument Versus EORTC QLQ-H&N43 in Head and Neck Cancer Patients - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/04/108785
Enrollment
75
Registered
2026-04-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C148- Malignant neoplasm of overlappingsites of lip, oral cavity and pharynx

Interventions

Intervention1: Nil: Nil

Sponsors

Dr. Shallu Bansal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years to 70 years irrespective of gender. 2. Patients who have undergone surgical treatment for head and neck cancer. 3. Patients who are clinically stable and able to understand and respond to the questionnaire. 4. Patients willing to participate in the study and who provide written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with severe cognitive impairment, psychiatric illness, or neurological disorders that would interfere with reliable questionnaire responses. 2. Patients who are critically ill or medically unstable at the time of data collection. 3. Patients with hearing, speech, or comprehension limitations that preclude meaningful participation, even with assistance. 4. Patients unwilling to participate or unable to provide informed consent.

Design outcomes

Primary

MeasureTime frame
Comparison of quality of life scores between the EORTC QLQ-H&N43 questionnaire and the newly developed 11-domain Quality of Life instrument in head and neck cancer patients.Timepoint: at 3month and 6th month postoperatively

Secondary

MeasureTime frame
1) Assessment of construct validity of the novel questionnaire by correlation with EORTC QLQ-H&N43 domain scores 2) Evaluation of internal consistency reliability of the novel questionnaire using Cronbach s alpha 3) Assessment of test retest reliability of the novel questionnaire in clinically stable patients 4) Evaluation of additional domains (financial, psychological, sexual, and spiritual) captured by the novel questionnaire 5) Assessment of feasibility, acceptability, and clarity of both questionnaires using patient rating scale Timepoint: 1) Assessment of construct validity of the novel questionnaire by correlation with EORTC QLQ-H&N43 domain scores Time Point: At 3 and 6 months post-treatment 2) Evaluation of internal consistency reliability of the novel questionnaire using Cronbach s alpha Time Point: At initial assessment (3 months post-treatment) 3) Assessment of test retest reliability of the novel questionnaire in clinically stable patients Time Point: 2 weeks interval after first assessment 4) Evaluation of additional domains (financial, psychological, sexual, and spiritual) captured by the novel questionnaire Time Point: At 3 and 6 months post-treatment 5) Assessment of feasibility, acceptability, and clarity of both questionnaires using patient rating scale Time Point: At the time of questionnaire administration (3 and 6 months)

Countries

India

Contacts

Public ContactDr Ashish Jakhetiya

Geetanjali Dental and Research Institute

drshallu23@yahoo.com09116155666

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026