Systematic Review of Fear of Cancer Recurrence Patient-Reported Outcome Measures: Evaluating Methodological Quality and Measurement Properties Using the COSMIN Checklist
Authors:
Maheu, C., Tock, W. L., Fisher, P., Galica, J., Singh, M., Centeno, I., Hébert, M., Moran, C., Pietruczuk, P., Dinkel, A., Zwaal, C., Thewes, B., and Estapé, T.
Abstract:
Background: Fear of cancer recurrence (FCR) is a common, distressing concern among cancer survivors, with implications for psychological well-being and quality of life. Despite the proliferation of patient-reported outcome measures (PROMs) to assess FCR, consensus on the most valid and reliable instruments remains limited. Objective: To conduct a comprehensive psychometric evaluation of FCR PROMs developed or validated between 2011 and 2023, using the full COSMIN methodology. This review builds on earlier work by systematically appraising both newly developed and adapted instruments to inform evidence-based PROM selection for clinical and research use. Methods: This review followed the COSMIN 10-step procedure and PRISMA 2020 guidelines. Six databases were searched from January 2011 to December 2023. A search cut-off of 31 December 2023 was applied to align with COSMIN feasibility recommendations and ensure sufficient time and resources for full psychometric evaluation across all included PROMs. Eligible studies included adults diagnosed with cancer and reported on the psychometric evaluation of a self-reported, Likert-scale-based FCR PROM. PROMs were appraised across eight psychometric properties using COSMIN's Risk of Bias checklist, criteria for good measurement properties, and modified Grading of Recommendations Assessment, Development, and Evaluation (GRADE) for evidence quality. Instruments were categorized as A, B, or C according to COSMIN's recommendations. Results: Of the 34 PROMs evaluated across 32 studies, 28 achieved COSMIN Category A status, indicating sufficient psychometric quality for clinical or research use. Among the 19 FCRI and FoP-Q instruments validated in new cultural or population contexts, 15 received a Category A rating, reflecting strong cross-cultural performance. Short forms such as the FCRI-SF and FoP-Q-SF demonstrated consistent psychometric strength across French, English, Portuguese, and Asian-language versions. Of the 14 newly developed PROMs-including the CWS-6, FCR4/7, CARQ-4, and FCR-1-12 achieved Category A. The FCR-1 was the only single-item PROM to demonstrate responsiveness, supporting its use in both screening and longitudinal monitoring. For practical guidance, five PROMs (FCR-1, FCRI-SF, FoP-Q-SF, FCR-7, and CWS) emerged as the most strongly supported for clinical use. Conclusions: This review provides a comprehensive evaluation of contemporary FCR PROMs and highlights substantial progress in the development of valid, reliable, and culturally adaptable tools. The FCRI, FoP-Q-SF, and several newly developed short forms, such as FCR7, CWS, and particularly, the FCR-1, emerge as strong candidates for use in clinical screening and longitudinal assessment. These findings offer clear evidence-based guidance for instrument selection in research and survivorship care. PROSPERO registration: CRD42023453783.