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Brief Title: The SEA CHANGE Study: A Self Management Intervention for Head and Neck Cancer Survivors
Official Title: The SEA-CHANGE Study: a Pilot Randomized Controlled Trial of the SElf-management After Cancer of the Head and Neck Group intErvention
Study ID: NCT04051697
Brief 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.
Detailed 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Royal Victoria Eye and Ear Hospital, Ireland, Dublin, , Ireland
St James Hospital, Ireland, Dublin, , Ireland
St Lukes Hospital, Ireland, Dublin, , Ireland
Name: Pamela Gallagher, PhD
Affiliation: Dublin City University
Role: PRINCIPAL_INVESTIGATOR