PET-CT guided, symptom-based, patient-initiated surveillance versus clinical follow-up in advanced head neck cancer (PET NECK 2)

Research question Does PETCT-guided, patient-initiated follow-up result in similar overall survival compared to current post-treatment routine surveillance for head and neck cancer (HNC) patients? Background HNC poses a considerable global health burden, with rapidly increasing incidence, severe morbidity, ~40% recurrence, and high mortality. International guidelines recommend regular routine follow-up, aiming to detect recurrences early and enable successful re-treatment. This regimen is effective at detecting recurrences. However, because detection rates are low in asymptomatic patients attending routine consultations, this routine surveillance regimen is inefficient, resource-intensive and increasingly unsustainable. Patients also report that follow-up schedules are too frequent, and may exacerbate fear of recurrence. In contrast, detection rates increase dramatically when patients initiate earlier review because of developing new symptoms. Additionally, small retrospective studies now show that PETCT scanning at 1-year post-treatment demonstrates high, but variable sensitivity (77-97%) and specificity (77-98%) for the detection of recurrent disease, and may be cost-effective. Hence, PETCT at 12 months may select the patients at very low recurrence risk to undergo patient-initiated follow-up. There is, however, conflicting poor-quality literature on (i) the efficacy of PETCT-guided follow-up in improving overall survival, and (ii) the efficacy of patient-initiated follow-up in HNC. Recently, NICE recommended evaluation of effectiveness and cost-effectiveness of PETCT in HNC follow-up as a priority research area. Aim and Objectives: With patients and clinicians, develop a patient-centred, evidenced-based and theoretically-informed complex intervention and information and support resource for PETCT-guided, patient-initiated follow-up for HNC. Compare the efficacy and cost-effectiveness of experimental follow-up (PETCT-guided and patient-initiated) versus current routine clinical follow-up in a randomised controlled trial. Assess differences in fear of recurrence, patient experience, and quality of life between the two follow-up regimens. Develop a recurrence and survival predictive model, based only on clinical factors, as an alternative, especially in low-resource settings. Concurrently collect samples to test future cancer surveillance technologies (future proofing). Methods and timelines for delivery (months): WS1: Establish a Patient Advisory Group to guide and deliver patient and public involvement (month 1-72). WS2: Undertake systematic reviews of barriers to self-referral and predictive clinical models of recurrence (1-12). WS3: Develop the experimental intervention through patient collaboration (1-13). 3a: Evaluate acceptability of the proposed intervention to patients and clinicians using qualitative interviews (1-12). 3b: Develop the intervention and information and support resource, through qualitative focus groups (1-13). WS4: Test feasibility of the developed intervention, with iterative qualitative evaluation and refinement (10-21). WS5: Randomised trial of PETCT-guided, patient-initiated follow-up versus routine clinical follow-up (22-72); with internal pilot; nested qualitative recruitment evaluation (24-41); mixed methods assessment of patient experience and fear of cancer recurrence (24-53), and cost-effectiveness assessment. WS6: Develop and validate a clinical predictive model for recurrence and survival (13-72). Anticipated Impact and Dissemination We expect our findings to have practice-changing impact for the 12,000 UK and the 640,000 world-wide patients diagnosed annually with HNC, as well as clinicians, the NHS, and international guidelines. Dissemination of findings will be undertaken by a multi-modal, multi-faceted, proactive approach, aided by our strong collaborations with patient-support groups and HNC professional bodies.