Clinical trial NCT04051697: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Cancer
Keywords: Head and Neck Cancer
Self-management
Intervention
Pilot Randomised Control Trial
Behavioural intervention
Quality of Life
Lead sponsor: Dublin City University
Sponsor class: OTHER
Collaborators: name: National University of Ireland, Maynooth
name: Newcastle University
name: St. James's Hospital, Ireland
name: St. Luke's Hospital
name: Royal Victoria Eye and Ear Hospital
First posted: 2019-08-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed (intervention vs usual care) non-blinded pilot randomised control trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Functional Assessment of the Cancer Therapy scale (FACT-G and Head and Neck Cancer Subscale (FACT H&N)) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Secondary outcomes:
measure: Changes in The Distress Thermometer scale from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the Social Role Participation Questionnaire (SRPQ) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the Fear of Recurrence/Relapse Scale from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the UK Cancer Costs Questionnaire (UKCC) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Other outcomes:
measure: Changes in the Cancer Survivors' Self-efficacy Scale (CS-SES) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the Cognitive Emotional Regulation Questionnaire (CERQ) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the Health Education Impact Questionnaire (HEIQ) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in the Patient Activation Measure (PAM) from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
measure: Changes in lifestyle behaviours from baseline up to 12 months
timeFrame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Locations:
city: Dublin
country: Ireland
facility: Royal Victoria Eye and Ear Hospital, Ireland
city: Dublin
country: Ireland
facility: St James Hospital, Ireland
city: Dublin
country: Ireland
facility: St Lukes Hospital, Ireland
Study officials:
affiliation: Dublin City University
name: Pamela Gallagher, PhD
role: PRINCIPAL_INVESTIGATOR
References: