Development of the ‘ACT now &amp; check-it-out’ intervention to support patient-initiated follow up for Head and Neck cancer patients

Matheson, Lauren; Greaves, Colin; Duda, Joan L.; Wells, Mary; Secher, Denis; Rhodes, Pat; Lorenc, Ava; Jepson, Marcus; Ozakinci, Gozde; Watson, Eila; Fulton-Lieuw, Tessa; Mittal, Saloni; Main, Barry; Nankivell, Paul; Mehanna, Hisham; Brett, Jo

doi:10.1016/j.pec.2023.108033

Cited by 1 publication

(2 citation statements)

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“…1 ). This study defined the patient-initiated follow-up strategy that is now being examined within the RCT [ 38 ]. Recruitment was over seven months (February to August 2022).…”

Section: Designmentioning

confidence: 99%

“…This programme of work included development of a bespoke I&S resource package [ 35 – 37 ] and an initial feasibility study to optimise the education session and I&S resource package given prior to the phase III Randomised Controlled Trial (RCT), which will formally assess the efficacy and cost-effectiveness of this patient-initiated active surveillance strategy compared to the current standard of care routine scheduled clinical follow-up.…”

Section: Introductionmentioning

confidence: 99%

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PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

Nankivell,

Gaunt,

Gaunt

et al. 2024

BMC Cancer

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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.

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“…1 ). This study defined the patient-initiated follow-up strategy that is now being examined within the RCT [ 38 ]. Recruitment was over seven months (February to August 2022).…”

Section: Designmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%