Feasibility study followed by a randomised controlled trial to test a new patient-led follow-up method for low-risk head and neck cancer patients
- Conditions
- Head and neck cancerCancer
- Registration Number
- ISRCTN13709798
- Lead Sponsor
- niversity of Birmingham
- Brief Summary
2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38987693/ (added 11/07/2024)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 698
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method