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Head and Neck CancerSEA-CHANGENCT04051697

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

A study testing SEA CHANGE intervention in people with Head and Neck Cancer, run by Dublin City University at 3 sites in Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer
What is being tested?
SEA CHANGE intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesIreland
Study dates
10 Sep 2018to 30 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

3 sites in 1 country.

Pamela Gallagher, PhD contact

+353170058958

pamela.gallagher@dcu.ie

Nicholas Clarke, PhD contact

+35317005317

nicholas.clarke@dcu.ie

Ireland3 sites, 3 recruiting

  • Royal Victoria Eye and Ear Hospital, Ireland

    Dublin

    Prof Timon, MD, +35314162677, timonsec@stjames.ie

    Recruiting

  • St James Hospital, Ireland

    Dublin

    Prof Timon, MD, +35314162677, timonsec@stjames.ie

    Recruiting

  • St Lukes Hospital, Ireland

    Dublin

    Sinead Brennan, MD, +35314065000, Sinead.Brennan@slh.ie

    Recruiting

Other trials in Ireland

About this study

Official title: 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.

Read the 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.

Being tested
SEA CHANGE intervention
Keywords
Head and Neck Cancer, Self-management, Intervention, Pilot Randomised Control Trial, Behavioural intervention, Quality of Life
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SEA CHANGE interventionBehavioural

    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.

Study groups in NCT04051697
Study groupRoleWhat they receive
Usual Care armNo interventionParticipants 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 armExperimentalParticipants 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.
Receives: Behavioral: SEA CHANGE intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

Secondary outcomes (4)

  1. 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.

    Measured: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

  2. 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.

    Measured: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

  3. 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.

    Measured: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

  4. 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.

    Measured: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2019
  2. Study start10 Sep 2018
  3. Primary completion30 Dec 2020 (estimated)
  4. Study completion30 Dec 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-armed (intervention vs usual care) non-blinded pilot randomised control trial
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04051697
Sponsor's protocol ID
DIFA-2017-022
Other IDs
DIFA-2017-022
Acronym
SEA-CHANGE
Status last verified
Aug 2019
First submitted
22 Jul 2019
Last updated
9 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing SEA CHANGE intervention in people with Head and Neck Cancer, run by Dublin City University at 3 sites in Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Pamela Gallagher, PhD (+353170058958, pamela.gallagher@dcu.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: 12 months; change from baseline (before randomisation) to post intervention, 6 months and 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04051697.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2019; AzTrials last refreshed its copy on 3 Nov 2026.

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