MedTrace Logo

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

NCT04051697 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • National University of Ireland, Maynooth

    collaborator OTHER

  • Newcastle University

    collaborator OTHER

  • St. James's Hospital, Ireland

    collaborator OTHER

  • St. Luke's Hospital

    collaborator UNKNOWN

  • Royal Victoria Eye and Ear Hospital

    collaborator OTHER_GOV

  • Dublin City University

    lead OTHER

Principal Investigators

  • Pamela Gallagher, PhD · Dublin City University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-10
Primary Completion
2020-12-30
Completion
2020-12-30

Countries

  • Ireland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04051697 on ClinicalTrials.gov