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A study to assess the Effectiveness of Comprehensive Intervention Programme among patients with Head and Neck Cancer

Effectiveness of Comprehensive Intervention Programme (CIP) on Quality of life (QOL), fatigue, self-efficacy, and psychosocial distress among patients with Head and Neck Cancer (HNC)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/04/018820
Enrollment
134
Registered
2019-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: C32- Malignant neoplasm of larynx Health Condition 2: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx

Interventions

Intervention1: Comprehensive intervention programme(CIP): CIP is an intervention developed by the researcher and will be implemented for the patients receiving radiotherapy for HNC. Components of CIP

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1 HNC patients in stage III, stage IVa. stage IVb receiving radiation therapy with curative intent 2 Age between 40 to 80 years 3 Able to read and write Kannada and/or English 4 Available during data collection period and willing to participate in the study.

Exclusion criteria

Exclusion criteria: 1 HNC patients with early stage vocal cord malignancy 2 HNC patients with distant metastasis 3 Secondary HNC 4 Previous history of cancers and cancer treatments 5 Patients with history of diagnosed mental health disorders 6 Patients having active infections

Design outcomes

Primary

MeasureTime frame
Primary outcome variable assessed will be the Quality of Life. The expected outcome of the study is improvement in Quality of LifeTimepoint: Primary outcome variable is Quality of Life, which will be assessed before starting the radiotherapy, on the completion of radiotherapy and at third and sixth month follow up.

Secondary

MeasureTime frame
Secondary outcome variables assessed will be fatigue, self-efficacy and psychosocial distressTimepoint: Secondary outcome variables also will be assessed before starting the radiotherapy, on the completion of radiotherapy and at third and sixth month follow-up.

Countries

India

Contacts

Public ContactShalini Ganesh Nayak

Manipal College of Nursing

anice.george@manipal.edu9632094766

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026