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

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

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.

Study Overview

• Status: Unknown
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: SEA CHANGE intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pamela Gallagher, PhD; Phone Number: +353170058958; Email: pamela.gallagher@dcu.ie
• Study Contact Backup: Name: Nicholas Clarke, PhD; Phone Number: +35317005317; Email: nicholas.clarke@dcu.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • Royal Victoria Eye and Ear Hospital, Ireland
    • Contact: Prof Timon, MD; Phone Number: +35314162677; Email: timonsec@stjames.ie
  • Dublin, Ireland
    • Recruiting
    • St James Hospital, Ireland
    • Contact: Prof Timon, MD; Phone Number: +35314162677; Email: timonsec@stjames.ie
  • Dublin, Ireland
    • Recruiting
    • St Lukes Hospital, Ireland
    • Contact: Sinead Brennan, MD; Phone Number: +35314065000; Email: Sinead.Brennan@slh.ie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Usual Care arm; 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).
EXPERIMENTAL: Intervention arm; 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.	Behavioral: SEA CHANGE intervention; The SEA CHANGE intervention consists of six 2.5 hour facilitated group workshop sessions. The sessions run over six consecutive weeks and are delivered face-to-face by a leader and peer facilitator (HNC survivor). Each session focuses on a specific self-management topic and the development/enhancement of a particular set of skills. There are opportunities for peer learning, skills practice and take-home exercises to consolidate skills development. In delivering the intervention, leaders/facilitators use a standardised approach following a leader's/facilitators' manual and participant toolkit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	FACT-G consists of 4 domains and 27 statements, asking participants to consider the previous week and rate their Quality of life (QoL) across physical, social/family, emotional, and functional domains on a five point likert scale (0-4). FACT H&N comprises 12 statements about HNC specific challenges and can be used independently of the FACT-G to indicate HNC specific QoL. Higher domain scores indicate higher QoL (Maximum domain scores: Physical 28; Social/Family 28; Emotional 24; Functional 28; FACT H&N subscale 48). The FACT-G and FACT H&N subscale have been widely used and validated and are commonly used to assess the QoL of HNC survivors.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in The Distress Thermometer scale from baseline up to 12 months	The distress thermometer measures an individuals level of distress during the past week and is scored on a 0 to 10 point Likert scale with 0 indicating "No distress" and 10 indicating "Extreme distress". Scores of 4 or more indicate moderate to extreme distress.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the Social Role Participation Questionnaire (SRPQ) from baseline up to 12 months	The SRPQ assesses an individual's perceptions of: 1) the importance of participation in diverse roles; 2) restrictions in role participation; and 3) satisfaction with performance in social roles. Mean scores are calculated separately for each of the 3 social role dimensions on Likert scales: 1) salience or role importance (scores; 1 "Not at all important" to 5 "Extremely important"); 2) physical difficulty with each role (i.e., role limitations) (scoring; 1 "No difficulty" to 4 "Unable to do") and 3) satisfaction with role performance (scoring; 1 "Not satisfied" to 5 "Extremely satisfied"). Because individuals may not engage in all roles, mean role satisfaction scores are calculated if participants respond to at least 9 of 12 role domains.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the Fear of Recurrence/Relapse Scale from baseline up to 12 months	The Fear of Recurrence/Relapse Scale is a five-item scale measuring patients' beliefs about recurrence of their cancer using 5-point Likert scales from 1 (Strongly agree) to 5 (Strongly disagree). Scores range from 5-25 and higher scores reflect a greater fear of cancer relapse.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the UK Cancer Costs Questionnaire (UKCC) from baseline up to 12 months	The UKCC is a modular questionnaire designed to capture the resources used by people with a current or previous diagnosis of cancer. Each question can be used in isolation. Captured activity includes primary care usage, community care usage, medications and personal social services. Societal costs are also captured including patient out-of-pocket costs, costs incurred by carers and time taken off work. The questionnaire has been appropriately modified for the Irish context.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the Cancer Survivors' Self-efficacy Scale (CS-SES) from baseline up to 12 months	The CS-SES measures self-efficacy in cancer survivors' by assessing confidence in performing various disease-related activities. The scale consists of 11 items scored on a 10 point scale with 1 being "not at all confident" to 10 being "totally confident". An overall score is determined using the mean of the 11 items.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the Cognitive Emotional Regulation Questionnaire (CERQ) from baseline up to 12 months	The CERQ measures what an individual thinks after experiencing threatening or stressful life events using a 36 item questionnaire focused on 9 domains; self-blame, blaming others, rumination, catastrophizing, putting into perspective, positive refocusing, positive reappraisal, acceptance and planning. Each item is scored on a Likert scale ranging from 1 (Almost never) to 5 (Almost always). Individual sub-scales are calculated by summing the scores from individual sub-scales with a range from 4 to 20.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the Health Education Impact Questionnaire (HEIQ) from baseline up to 12 months	The HEIQ is used as a measure of health education/ self-management behaviors in eight domains; Health Directed Behavior, Positive and Active Engagement in Life, Emotional Well-being, Self-monitoring and Insight, Constructive Attitudes and Approaches, Skills and Technique Acquisition, Social Integration and Support, and Health Service Navigation. Individuals are asked to indicate their level of agreement with 42 statements across the eight domains on four point Likert scales (1 "strongly disagree" to 4 "Strongly agree"). Higher scores indicate greater performance of specific self-management behaviors. Higher scores on the emotional well-being domain denote higher levels of negative affect. Each domain is used individually by calculating the mean score.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in the Patient Activation Measure (PAM) from baseline up to 12 months	PAM assesses an individual's knowledge, skills and confidence for self-management. The measure contains 13 items measured on 4 point Likert scales (1 "Strongly disagree" to 4 "Strongly agree"). A total score is derived by dividing the raw score by the number of items answered and multiplying by 13. Calibration tables are used to apply a range of 1-100 with higher scores indicating higher patient activation.	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months
Changes in lifestyle behaviours from baseline up to 12 months	Alcohol and tobacco use	12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

Collaborators and Investigators

• Sponsor: Dublin City University
• Collaborators: Newcastle University; National University of Ireland, Maynooth; Royal Victoria Eye and Ear Hospital; St. James's Hospital, Ireland; St. Luke's Hospital
• Investigators: Principal Investigator: Pamela Gallagher, PhD, Dublin City University

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2018
• Primary Completion (ANTICIPATED): December 30, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: July 22, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (ACTUAL): August 9, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 9, 2019
• Last Update Submitted That Met QC Criteria: August 7, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; Quality of Life; Intervention; Self-management; Behavioural intervention; Pilot Randomised Control Trial
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: DIFA-2017-022 (OTHER_GRANT: Health Research Board)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No