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The SEA-CHANGE study: a pilot randomised controlled trial of the SElf-management After Cancer of the Head And Neck Group intErvention

Background: Head and neck cancer (HNC) and its treatment pose unique challenges in addition to those associated with cancer more generally, including facial disfigurement and impairments in eating, swallowing, breathing and speech, which can have a profound impact on one’s physical, social, and psychological wellbeing. There is a lack of methodologically sound and theoretically based studies examining interventions that address the specific needs of HNC survivors. Self-management interventions empower patients to care for themselves by equipping them with the skills needed to deal with health-related problems, maintain life roles, and manage negative emotions, and their utility has been demonstrated across a number of long-term health conditions. Developing a self-management intervention for HNC survivors may help them to overcome the unique challenges associated with this condition and its treatment.
Aim: To test the feasibility of implementing the SElf-management After Cancer of the Head And Neck Group intErvention (SEA-CHANGE), a theoretically derived intervention designed to increase health-related quality of life (HRQL) and participation in life activities and decrease distress in HNC survivors following the completion of primary treatment.
Methods/Design: A two-armed (intervention, usual care) pilot randomised study alongside a qualitative process evaluation will be conducted to assess the fidelity, feasibility and acceptability of the intervention. One hundred and forty people who completed primary treatment for HNC within the past year will be recruited from the outpatients clinic of a major urban hospital and randomised to either the intervention or usual care. The intervention comprises 8 fortnightly 90-minute sessions facilitated by two trained leaders, one of whom is a HNC survivor. The primary outcome of interest is HRQL; secondary outcomes are distress, participation in life activities and healthcare utilisation. Finally, the AdePT process (A process for Decision-making after Pilot and feasibility Trials)will be usedto support decision-making regarding progression to a definitive trial.
Conclusion: This study will provide information about the feasibility and acceptability of a self-management intervention for HNC survivors following their primary cancer treatment. It is anticipated that the intervention will achieve tangible health, social and economic returns at an individual and societal level.