Rehabilitation after neck dissection for head and neck cancer Cancer
Conditions
Interventions
1. Control Group (Best Practice NHS Post-Discharge Care)
Treatment Given: Routine NHS care including ward-based physiotherapy (respiratory care, positioning, walking, activities of daily living, neck
Sponsors
University of Warwick
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. People aged 18 years or over 2. Diagnosis of HNC with requirement for a neck dissection as part of their treatment with curative intent. Including those undergoing completion neck dissection following positive sentinel node biopsy or open neck node biopsy. 3. Able to attend out-patient physiotherapy appointments. 4. Provide informed consent.
Exclusion criteria
Exclusion criteria: 1. People for whom intensive post-discharge physiotherapy is expected (e.g., scapula/scapula tip and/or latissimus dorsi free flaps or components thereof). This constitutes 3-5% of the neck dissection population and clinical equipoise regarding the role of physiotherapy is less evident. 2. People with a pre-existing, long-term disease affecting the shoulder, e.g., hemiplegia. 3. People who had prior neck dissection surgery on the affected side. People who had a previous neck dissection on the affected side (except sentinel lymph node biopsy requiring completion neck dissection) 4. People undergoing Lymph Node Biopsy or Sentinel Lymph Node Biopsy only. 5. Previous entry in the present trial. 6. Unable to adhere to trial processes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Shoulder pain and function measured using the participant-reported Shoulder Pain and Disability Index (SPADI) questionnaire (total score) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures are assessed at 6 weeks, 3, 6 and 12 months unless specified otherwise: 1. Shoulder pain and function measured using the SPADI total score (secondary outcomes at 6 weeks and 6 months only) 2. Pain, function and disability subdomains measured using the individual SPADI domains 3. Health-related quality of life measured using the EQ-5D-5L*; EORTC cancer-specific questionnaires (C30(core); H&N35 (head and neck-specific 4. Mental wellbeing measured using the Short Warwick-Edinburgh Mental Wellbeing Scale 5. Exercise adherence measured using the Exercise Adherence Rating Scale at 6 weeks only 6. Adverse events including surgical complications* 7. Health resource use measured using a questionnaire* (*3-month assessment for adverse events, EQ-5D-5L and health utilisation questionnaire only) The study will also conduct a process evaluation including qualitative interviews of participants and physiotherapists to wider experiences, perceptions, reach and implementation of the trial and treatments from a patient and physiotherapist perspective. | — |
Countries
England, United Kingdom
Contacts
Public ContactChrissy Evans
Outcome results
None listed