Abstract
Background:
Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.
Methods:
PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
Discussion:
We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
Trial registration:
ISRCTN: 13,709,798; 15-Oct-2021.
Approximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.
Methods:
PETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.
Discussion:
We hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.
Trial registration:
ISRCTN: 13,709,798; 15-Oct-2021.
| Original language | English |
|---|---|
| Article number | 823 |
| Journal | BMC Cancer |
| Volume | 24 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 10 Jul 2024 |
Bibliographical note
Additional members of the PETNECK2 research team: Ahmad Abou-Foul (Institute of Cancer and Genomic Sciences, University of Birmingham); Andreas Karwath (Institute of Cancer and Genomic Sciences, University of Birmingham); Ava Lorenc (QuinteT research group, Bristol Medical School, University of Bristol); Barry Main (University Hospitals Bristol and Weston NHS Trust); Colin Greaves (School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham); David Moore (Institute of Applied Health Research, University of Birmingham); Denis Secher (Patient Advisory Group lead); Eila Watson (Oxford School of Nursing and Midwifery, Oxford Brookes University); Georgios Gkoutos (Institute of Cancer and Genomic Sciences, University of Birmingham); Gozde Ozakinci (Health Psychology Research Group, University of Stirling); Jane Wolstenholme (Nuffield Department of Population Health, University of Oxford); Janine Dretzke (Institute of Applied Health Research, University of Birmingham); Jo Brett (Department of Midwifery, Community and Public Health, Oxford Brookes University); Joan Duda (School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham); Lauren Matheson (Oxford Institute of Nursing, Midwifery and Allied Health Research, Oxford Brookes University); Marcus Jepson (QuinteT research group, Bristol Medical School, University of Bristol); Mary Wells (Nursing Directorate, Imperial College Healthcare NHS Trust, Charing Cross Hospital); Melanie Calvert (Institute of Applied Health Research, University of Birmingham); Pat Rhodes (Patient Representative); Philip Kiely (University Hospitals Bristol and Weston NHS Foundation Trust); Steve Thomas (Bristol Dental School, University of Bristol); Stuart Winter (Nuffield Department of Surgical Sciences, University of Oxford); Wai-lup Wong (East and North Hertfordshire NHS Trust, Mount Vernon Cancer Centre).Keywords
- Phase III randomised clinical trial
- Head and neck cancer
- Feasibility study
- Patient-initiated follow-up
