Clinical trial · Interventional
The SEA CHANGE Study: A Self Management Intervention for Head and Neck Cancer Survivors
The SEA-CHANGE Study: a Pilot Randomized Controlled Trial of the SElf-management After Cancer of the Head and Neck Group intErvention
NCT04051697CI-TRIAL-00039991SEA-CHANGEunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SEA CHANGE intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care arm
- description
- 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).
- type
- EXPERIMENTAL
- label
- Intervention arm
- description
- 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.
- interventionNames
- Behavioral: SEA CHANGE intervention
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.