Head and neck cancer Cancer
Conditions
Interventions
Patients have a PET-CT scan around 1 year after finishing treatment. If no cancer is detected, they will be educated by a nurse, clinical nurse specialist, speech and language therapist or dietitian a
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 19/01/2024: Feasibility : 1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma 2. Patients at least 6 months post completion of curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis 3. Patients must be aged 18 years or older 4. Provision of informed consent prior to any study-specific procedures RCT: Inclusion Criteria – Registration Stage For inclusion in the registration stage of the RCT, patients should fulfil the following criteria: 1. Histological or cytological confirmation of oral, laryngeal, nasopharyngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma 2. Patient at 6 – 14 months post curative intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis 3. Provision of informed consent prior to any study-specific procedures 4. The patient must be aged 18 years or over 5. Willingness to comply with the protocol for the duration of the study Inclusion Criteria – Randomisation Stage For inclusion in the RCT, patients should fulfil the following criteria: 1. Patient with no clinical symptoms or signs of loco-regional or distant metastasis or no evidence of recurrent cancer 2. Patient at 11-14 months post curative intent treatment by any modality (surgery, radiation or combination treatments) 3. Patient willing to comply with the protocol for the duration of the study Previous participant inclusion criteria as of 13/10/2023 to 19/01/2024: 1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma 2. Patients at least 6 months post completion of curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis 3. Patients must be aged 18 years or older 4. Provision of informed consent prior to any study-specific procedures Previous participant inclusion criteria: 1. Histological or cytological confirmation of oral, laryngeal, hypopharyngeal or oropharyngeal squamous cell carcinoma 2. Patients at one year after curative-intent treatment by any modality (surgery, radiation or combination treatments), with no clinical symptoms or signs of loco-regional or distant metastasis 3. Patients must be aged 18 years or older 4. Provision of informed consent prior to any study-specific procedures
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 19/01/2024: Feasibility : 1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated in the inclusion criteria 2. Patients who are pregnant 3. Patients with clinical symptoms or signs of loco-regional or distant metastasis 4. Any patient already enrolled in a clinical trial where scheduled follow-up is a requirement of that trial protocol 5. Significant concern by patient or clinician regarding the ability of patient to undertake patient-initiated follow-up (must record in the Screening/Enrolment Log) RCT: Exclusion Criteria – Registration Stage Patients should not be registered in the RCT if any of the following apply: 1. Patient with non-squamous cell carcinoma tumours, or those from sites other than those stated above 2. Patient who is pregnant 3. Patient with clinical symptoms or signs or radiological evidence of loco-regional or distant metastasis 4. Patient with confirmed unknown primary cancer 5. Patient already enrolled in a head and neck clinical trial where scheduled follow up is part of the trial protocol 6. Significant concern by patient or clinician regarding the ability of patient to undertake patient initiated follow up (must record in the Screening/Enrolment Log) Exclusion Criteria – Randomisation Stage Patients should not be randomised in the RCT if any of the following apply: 1. Patient who has relapsed or presented with cancer recurrence since registration 2. Patient who is pregnant 3. Any patient enrolled in a head and neck clinical trial where scheduled follow up is part of the trial protocol 4. Significant concern by patient or clinician regarding the ability of patient to undertake patient initiated follow up Previous participant exclusion criteria as of 13/10/2023: 1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated in the inclusion criteria 2. Patients who are pregnant 3. Patients with clinical symptoms or signs of loco-regional or distant metastasis 4. Any patient already enrolled in a clinical trial where scheduled follow-up is a requirement of that trial protocol 5. Significant concern by patient or clinician regarding the ability of patient to undertake patient-initiated follow-up (must record in the Screening/Enrolment Log) Previous participant exclusion criteria: 1. Patients with non-squamous cell carcinoma tumours, or those from sites other than those stated above 2. Patients who are pregnant 3. Patients with clinical symptoms or signs or radiological evidence of loco-regional or distant metastasis 4. Any patient already enrolled in a clinical trial where scheduled follow-up is part of that trial protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 24/01/2024: Feasibility: 1. Patient recruitment and consent rates determined as a proportion of eligible patients measured using screening logs and informed consent forms completed at the 6-month timepoint 2. Patient dropout rates measured using withdrawal forms received at the 6-month time point 3. Patient-reported outcome completion rates measured using questionnaires completed at the 6-month timepoint RCT: Overall survival time Previous primary outcome measure as of 19/01/2024 to 24/01/2024: Feasibility: There was no primary outcome measure RCT: Overall survival time Previous primary outcome measures: 1. Patient recruitment and consent rates determined as a proportion of eligible patients measured using screening logs and informed consent forms completed at the 6-month timepoint 2. Patient dropout rates measured using withdrawal forms received at the 6-month time point 3. Patient-reported outcome completion rates measured using questionnaires completed at the 6-month timepoint 4. Duration of centre set-up measured using the average length of time for each site to set-up at the 6-month timepoint 5. Qualitative data on patient and clinician acceptance of the intervention and nurse/allied health professionals views towards the training and delivery of the PETNECK2 Education Session, measured using app/booklet use at the 6-month timepoint | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 24/01/2024: Feasibility; 1. Duration of centre set-up measured using the average length of time for each site to set-up at the 6-month timepoint 2. Qualitative data on patient and clinician acceptance of the intervention and nurse/allied health professionals' views towards the training and delivery of the PETNECK2 education session, measured using app/booklet use at the 6-month timepoint RCT: 1. Patient experience as assessed by the CQC friends and family question ‘Overall, up to this point in time how was your experience of cancer follow-up in the PETNECK2 trial?’ at 6, 12 and 24 months follow up 2. Fear of Cancer Recurrence as assessed by the 9-item FCR Inventory Short form questionnaire at baseline, 12 and 24 months. 3. Quality of life as assessed by the EQ-5D-5L questionnaire, at baseline, 6, 12 and 24 months follow up. 4. Quality of life as assessed by the EORTC General QLQ-C30 and head and neck specific H&N43 questionnaires at baseline, 12 and 24 months. Previous secondary outcome measure as of 19/01/2024 to 24/01/2024: Feasibility; 1. Patient recruitment and consent rates determined as a proportion of eligible patients 2. Patient dropout rates 3. Patient-reported outcomes completion rates (whether patients can complete and return them adequately) 4. Duration of centre set-up measured using the average length of time for each site to set-up at the 6-month timepoint 5. Qualitative data on patient and clinician acceptance of the intervention and nurse/allied health professionals' views towards the training and delivery of the PETNECK2 education session RCT: 1. Cost-effectiveness measured using incremental cost per quality-adjusted life year gained (using EQ-5D-5L) and resource use data collection, including number and reasons for healthcare visits (including nurses and GPs) 2. Recurrence and distant metastasis: 2.1. Disease-free survival time 2.2. Time from treatment to first detection of recurrence 2.3. TNM stage a | — |
Countries
England, Scotland, United Kingdom, Wales
Outcome results
None listed