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

Dublin City University

Status: Unknown

Conditions: Head and Neck Cancer

Treatments: Behavioral: SEA CHANGE intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04051697

DIFA-2017-022 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• had a pathologically confirmed diagnosis of an invasive primary tumour in the head and neck (oral cavity, salivary glands, nasal cavity, sinuses, middle ear, pharynx and larynx);
• have undergone and completed treatment by surgery, chemotherapy, radiotherapy or a combination thereof;
• are aged 18 or older at the time of their HNC diagnosis;
• are within 12 months of having completed their primary treatment; and
• have provided written informed, consent.

Exclusion criteria

• are unable to read or speak English;
• had a second invasive primary cancer other than non-melanoma skin cancer diagnosed after the HNC (as these patients are likely to be more focused on the treatment of their second cancer rather than self-management of their HNC);
• are unable to provide informed consent (e.g., if they have dementia/Alzheimer's disease); or
• have other known medical condition or other reason why they would be unable to take part.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Usual Care arm

No Intervention group

Description:

Participants allocated to the control group will receive their usual care. Healthcare professionals within the designated sites will deliver aftercare treatment as usual, with no changes to the patient's clinical care. Participants in this arm do not receive the self-management intervention (SEA CHANGE).

Intervention arm

Experimental group

Description:

Participants in the intervention group will receive usual care and will be offered access to the self-management intervention (SEA CHANGE). Healthcare professionals within the designated sites will deliver aftercare treatment as usual, with no changes to the patient's clinical care.

Treatment:

Behavioral: SEA CHANGE intervention