Patients with stage III non-small cell lung cancer (NSCLC) are at high risk of developing post-treatment recurrences (50–78%) during follow-up. As more effective treatments are now available, especially for patients with oligometastatic disease, earlier detection of recurrences may prolong survival and health-related quality of life (HRQOL). With the use of 2'-deoxy-2'-[¹⁸F]fluoroglucose positron emission tomography/CT ([¹⁸F]FDG PET/CT) during follow-up, recurrences may be detected earlier. Therefore, the primary objective of this study is to compare the 3-year overall survival of patients with stage III NSCLC during follow-up surveillance with [¹⁸F]FDG PET/CT versus follow-up with conventional CT (usual care). Secondary objectives address the number, location and timing of recurrences, as well as HRQOL, cost-effectiveness and patient experiences of PET/CT scans.

In this multicentre randomised controlled clinical trial, 690 patients with stage III NSCLC (8th edition International Association for the Study of Lung Cancer (IASLC) Tumor, Nodes, Metastasis (TNM) classification) who completed curative intended treatment and started follow-up care (which may include adjuvant therapy) will be randomised 1:1 to either the intervention ([¹⁸F]FDG PET/CT) or the control group (CT). Patients will undergo follow-up scans during visits at 6, 12, 18, 24 and 36 months. Data will be collected using validated questionnaires, electronic case report forms and data extractions from the electronic health records. Additionally, blood samples will be collected, and interviews will be conducted.

The study protocol has been approved by the Medical Ethical Committee of the Radboudumc and review boards of all participating centres. Written informed consent will be obtained from all participants. Study results will be published in international peer-reviewed scientific journals and presented at relevant scientific conferences. Data will be published in a data repository or other online data archive.

NCT06082492.

The increasing prevalence of chronic conditions and multimorbidity places a significant burden on patients and leads to increasing challenges for healthcare systems, especially in primary care. Recognising the multifaceted nature of chronic conditions, the Assessment of Burden of Chronic Conditions (ABCC) tool was developed to support person-centred care, by facilitating shared decision-making and self-management. This study aims to evaluate the cost-effectiveness of the ABCC tool in primary care.

This cost-effectiveness analysis was conducted over 18 months alongside a clustered, two-arm quasi-experimental study in primary care in the Netherlands.

The study included 231 participants diagnosed with chronic obstructive pulmonary disease (COPD), asthma, type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF). Of these, 173 were assigned to the intervention group and 58 to the control group.

The intervention group was intended to incorporate the ABCC tool into routine consultations, while the control group had to continue care as usual.

Outcomes were assessed from a societal perspective, including quality-adjusted life years (QALYs) derived via the EuroQol-5D-5L (EQ-5D-5L) questionnaire. Costs were measured using adapted versions of the Productivity Costs Questionnaire (PCQ) and Medical Consumption Questionnaire (MCQ). Sensitivity analyses (SAs) included a healthcare perspective, per-protocol analysis (to account for disruptions caused by COVID-19) and exclusion of home care costs (to address extreme outliers). Moreover, all analyses were performed for well-being-adjusted life years (WALYs), derived from the ICEpop CAPability measure for Adults (ICECAP-A) questionnaire.

The ABCC tool was more expensive and effective than usual care, with an incremental cost-effectiveness ratio (ICER) of 64 525 per QALY and a 29% probability of cost-effectiveness. With the exception of the healthcare perspective, the SAs yielded more favourable outcomes in terms of cost-effectiveness, with ICERs (probability of cost-effectiveness) of 41 484 (31%), 8683 (58%) and 23 905 (48%) for a healthcare perspective, per-protocol analysis and exclusion of home care costs, respectively. Outcomes for QALY and WALY were comparable.

While the primary analysis suggested a relatively low probability of cost-effectiveness, the SAs showed higher probabilities. The per-protocol analysis suggested that the ABCC tool can be cost-effective when actually used.

NCT04127383.