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The SEA CHANGE Study: A Self Management Intervention for Head and Neck Cancer Survivors — SEA-CHANGE  

Head and Neck Cancer Clinical Trial

Official title:
The SEA-CHANGE Study: a Pilot Randomized Controlled Trial of the SElf-management After Cancer of the Head and Neck Group intErvention

Clinical Trial Summary

This study aims to test the feasibility of implementing the Self-Management after Cancer of the Head and Neck Group Intervention (SEA-CHANGE), designed to promote quality of life and participation in life activities and reduce distress in people who have completed primary treatment for head and neck cancer as compared to usual care.

Clinical Trial Description

Head and neck cancer (HNC) and its treatment are associated with specific challenges such as facial disfigurement and impairments in speech, breathing and swallowing, and can have a negative impact on well-being. Self-management interventions can provide people with skills to deal with health-related problems, maintain life roles, and manage negative emotions, and have been found to increase confidence, improve quality of life, and reduce health service use across a range of chronic conditions.

The aim of this study is to pilot a self-management intervention (SEA-CHANGE) designed to promote quality of life and participation in life activities, and reduce distress in people who have completed primary treatment for HNC as compared to usual care. The study includes: (1) a pilot randomised study to assess the feasibility and acceptability of the intervention and its related procedures; (2) a qualitative process evaluation of the intervention; and (3) a systematic decision-making process regarding progression to a definitive trial. The expected outcome is a self-management intervention that is feasible and acceptable to HNC survivors and has the potential to realise both health benefits and economic gains. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04051697
Study type Interventional
Source Dublin City University
Contact Pamela Gallagher, PhD
Phone +353170058958
Email pamela.gallagher@dcu.ie
Status Recruiting
Phase N/A
Start date September 10, 2018
Completion date December 30, 2020
View Details
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