1. A study protocol for individualized prognostic counselling in the palliative phase.
- Author
-
van den Besselaar BN, Sewnaik A, Dorr MC, Hoesseini A, Hardillo JA, Baatenburg de Jong RJ, and Offerman MPJ
- Subjects
- Humans, Prognosis, Prospective Studies, Head and Neck Neoplasms psychology, Head and Neck Neoplasms therapy, Cohort Studies, Female, Male, Quality of Life psychology, Decision Making, Qualitative Research, Palliative Care methods, Palliative Care psychology, Counseling methods, Counseling standards
- Abstract
Background: Head and neck squamous cell cancer (HNSCC) has a poor prognosis, with approximately 25-30% of patients transitioning into the palliative phase at some point. The length of this phase is relatively short, with a median duration of five months. Patients in this stage often have increased prognostic information needs. Unfortunately, predicting individual life expectancy in this phase is particularly challenging, as physicians and patients tend to overestimate survival. To address this issue, we developed the prognostic model OncologIQ Palliative based on user preferences. In this study, we now aim to assess the clinical impact of utilizing this model during counselling., Methods: This study will employ both quantitative and qualitative approaches. The primary outcome is decisional conflict and satisfaction with the decision-making process after counselling without (cohort 1) and with (cohort 2) OncologIQ Palliative. Therefore, a prospective sequential cohort study will be conducted. Secondary outcomes include the amount of palliative treatment, overall survival rates, and quality of life. These measurements will be collected after the intervention. Additionally, patients' perspectives on the decision-making process and proactive care planning, including end-of-life discussions, will be explored through interviews., Discussion: By offering more personalized prognostic information for HNSCC patients in the palliative phase, we anticipate a shift towards more patient-centred counselling. This approach can facilitate enhanced end-of-life discussions and better proactive care planning. Patients may experience reduced decisional conflict, feel better prepared for what's coming, and find assistance in their decision-making process. This could potentially lead to fewer palliative treatments. Overall, these aspects can contribute to a better quality of life and quality of care for HNSCC patients in the last phase of their lives., Trial Registration: This study was registered November 18, 2024, on ClinicalTrials.gov: NCT06699316., Competing Interests: Declarations. Ethics approval and consent to participate: Ethics approval to start inclusion of patients for cohort 1 was granted by the ethics committee of the Erasmus MC (MEC-number: MEC-2022-0473, version 2.0, dated 13-12-2022). Ethical approval for the initiation of cohort 2 is granted by the ethics committee of the Erasmus MC (MEC-number: MEC-2024-0621, version 1.0, dated 27-08-2024). All participants will be required to provide their informed consent in writing before inclusion in the study. Any protocol modifications will be submitted as an amendment to the ethics committee and updated in Clinical Trial registry. These changes to the research will be made after a favourable opinion by the accredited ethics committee of the Erasmus MC. The study will be conducted according to the principles of the Declaration of Helsinki, Gedragscode Gezondheidsonderzoek 2022 and in accordance with the Erasmus MC Research Code and General Data Protection Regulation. Given the very low-risk nature of this study and that it is classified as Non-WMO, we did not establish a Data Monitoring Committee, report adverse events, or conduct auditing. The METC has approved this approach. Handling of personal data will comply with the Dutch Personal Data Protection Act. All data will be processed digitally, in a protected area. Subjects, and their data will be coded by a serial number (patient identification code), which is not based on the patient initials or birthdate. We will use a subject identification code list to link the data to the subject. Data will be stored in a secured folder and additionally secured by a password. Only the executive researchers and research coordinator will have access to the key. Consent for publication: Not applicable. Competing interests: The authors declare no competing interests., (© 2025. The Author(s).)
- Published
- 2025
- Full Text
- View/download PDF