Head and neck cancer Cancer
Conditions
Interventions
Study design
This project comprises three workstreams:
1. Systematic review to inform intervention development
2. Co-production workshops using a Living Labs approach to design and refine the interven
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Patients with a HNC diagnosis 2. Patients presenting with Stage 1a oedema or above. Surgical patients at least 8 weeks post treatment 3. Oncology patients at least 8 weeks post chemo-radiation. 50 Gy or higher dose of radiation to bilateral neck and primary tumour site in 30 or more fractions 4. Aged 18 years or older 5. All genders
Exclusion criteria
Exclusion criteria: 1. Medical contraindications 2. Patients with active/recurrent HNC disease 3. Patient who are unable to provide informed consent 4. Patients with head and neck lymphedema from non cancer aetiologies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1.Acceptability and appropriateness of the intervention and outcome measures measured using qualitative semi-structured interviews and reflexive thematic analysis during the intervention and after the intervention 2.Acceptability of the study protocol measured using qualitative semi-structured interviews and reflexive thematic analysis during the intervention and after the intervention 3.Understanding of the mechanism of change measured using qualitative semi-structured interviews and reflexive thematic analysis during the intervention and after the intervention 4.Contextual factors influencing intervention delivery and participation measured using qualitative semi-structured interviews and reflexive thematic analysis during the intervention and after the intervention 5.Number of patients screened measured using the study screening log throughout the recruitment period 6.Number of eligible and ineligible patients and reasons for ineligibility measured using the study screening log throughout the recruitment period 7.Number of patients agreeing to participate and associated timepoint measured using study recruitment records throughout the recruitment period 8.Reasons for refusal to participate measured using study recruitment records at the point of recruitment approach 9.Number of patients retained in the study measured using study retention records at follow-up 10.Reasons for withdrawal from the study and timepoint of withdrawal measured using study withdrawal records throughout study participation 11.Adverse events measured using adverse event reporting records throughout study participation 12.Intervention fidelity measured using a fidelity checklist used to record and standardise consultations and document deviations at each intervention consultation 13.Intervention adherence measured using a daily tick-box diary daily throughout the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Lymphoedema-related quality of life measured using the Comprehensive Assessment of Lymphedema Impact in the Head and Neck (CALI-HaN) questionnaire at baseline, 3 months and 12 months 2. Swallowing-related quality of life measured using the MD Anderson Dysphagia Inventory (MDADI) at baseline, 3 months and 12 months 3. Swallowing performance and functional status measured using the Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) at baseline, 3 months and 12 months 4. Swallowing function measured using the 100-mL Water Swallow Test (bedside timed swallow test) at baseline, 3 months and 12 months 5. External head and neck lymphoedema severity measured using the MD Anderson Cancer Center Head and Neck Lymphedema (HNL) Rating Scale through palpation at baseline, 3 months and 12 months 6. Pharyngeal swallowing function and dysphagia severity measured using videofluoroscopic swallow study (VFSS) and the Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) rating scale at baseline, 3 months and 12 months 7. Internal lymphoedema severity measured using flexible nasendoscopy (FNE) and the Patterson Oedema Rating Scale at baseline, 3 months and 12 months 8. Tissue fluid content in the head and neck region measured using tissue dielectric constant assessment with the LymphScanner device at baseline, 3 months and 12 months 9. Superficial tissue induration and skin stiffness measured using the Skin Fibrometer at baseline, 3 months and 12 months 10. External appearance of head and neck lymphoedema measured using standardised digital photographs taken from frontal, lateral, neck extension and neck flexion positions at baseline, 3 months and 12 months 11. Intervention frequency, intensity and duration measured using digitally recorded intervention delivery data pre-intervention and post-intervention | — |
Countries
United Kingdom
Contacts
Public ContactAlison Smith
Outcome results
None listed