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

NCT04051697 | Unknown

• 1 other identifier: DIFA-2017-022
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Self-management; Intervention; Pilot Randomised Control Trial; Behavioural intervention; Quality of Life

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

• Changes in The Distress Thermometer scale from baseline up to 12 months

  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

  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

  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

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

Other Outcomes (5)

• Changes in the Cancer Survivors' Self-efficacy Scale (CS-SES) from baseline up to 12 months

  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

  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

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

Study Arms (2)

Usual Care arm

NO INTERVENTION

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

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

Interventions

SEA CHANGE intervention BEHAVIORAL

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.

Intervention arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dublin City University: lead
• National University of Ireland, Maynooth: collaborator
• Newcastle University: collaborator
• St. James's Hospital, Ireland: collaborator
• St. Luke's Hospital: collaborator
• Royal Victoria Eye and Ear Hospital: collaborator

Study Sites (3)

Royal Victoria Eye and Ear Hospital, Ireland

Dublin, Ireland

RECRUITING

St James Hospital, Ireland

Dublin, Ireland

RECRUITING

St Lukes Hospital, Ireland

Dublin, Ireland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Pamela Gallagher, PhD

  Dublin City University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Gallagher, PhD

CONTACT

+353170058958; pamela.gallagher@dcu.ie

Nicholas Clarke, PhD

CONTACT

+35317005317; nicholas.clarke@dcu.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Pamela Gallagher

Model Details: Two-armed (intervention vs usual care) non-blinded pilot randomised control trial

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 9, 2019
• Study Start: September 10, 2018
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IE (3)