Anxiety, depression and fear of cancer recurrence in uveal melanoma survivors and ophthalmologist/oncologist communication during survivorship in France - protocol of a prospective observational mixed-method study.

Background: Quality of life (QoL) in patients undergoing surveillance for uveal melanoma (UM) can be affected by psychological sequelae. Fear of cancer recurrence (FCR) may be acute especially when prognostication indicates an increased risk of metastatic recurrence. Communication with an ophthalmologist or oncologist can then play a key role in impacting QoL.
Methods: In this prospective study co-designed with patient's partners and using a mixed-method approach, 250 patients at high versus low risk of metastatic recurrence are recruited in a national UM reference centre in France. At T1, after the 6-months post-treatment surveillance visit, dyads of clinicians and eligible patients complete a questionnaire to assess their respective experience of the communication during that consultation. Patients also complete questionnaires assessing their health literacy, information preference, and satisfaction with the information received (EORTC QLQ-INFO25), genomic testing knowledge, genomic test result receipt, satisfaction with medical care (EORTC PATSAT-C33), perceived recurrence risk, anxiety and depression (HADS), fear of cancer recurrence (FCRI) and quality of life (EORTC QLQ-C30 and QLQ-OPT30). At 12-months post-treatment (T2), patients complete again the HADS, FCRI, EORTC QLQ-C30 and QLQ-OPT30. Multilevel analyses will assess the effect of satisfaction with the information received on FCR and QoL accounting for the clinicians' and patients' characteristics. In-depth interviews planned sequentially with ≈25 patients will deepen understanding of patients' care experience.
Discussion: As information on prognosis based on medical parameters becomes widely integrated into oncology practice, this study will highlight UM survivors' information expectations and satisfaction with communication, and its effect on FCR and QoL. Culturally adapted recommendations for doctor-patient communication will be provided for contexts of oncology surveillance involving poor prognosis in cases of recurrence.
Trial Registration: NCT06073548 (October 4, 2023).
Competing Interests: Declarations Ethics approval and consent to participate The project was validated on 01/09/2023 by the institutional review board (IRB) from Institut Curie, in accordance with the Declaration of Helsinki. Number DATA230157. Furthermore, it has been registered to clinicaltrial.gov, Nr. NCT06073548. Consent to participate Not applicable. Consent for publication N/A: this paper does not contain any patient or physician data. Competing interests Bernhard Holzner holds IPRs on the CHES software tool used in the study. The other authors declare no conflicts of interest.
(© 2024. The Author(s).)