Integration of palliative care into phase I oncology trials: A qualitative interview study with patients, informal caregivers, and healthcare providers
Frederick Daenen, Anne van Driessche, Anne-Lore Scherrens, Annelies Janssens, Sylvie Rottey, Lore Decoster, Peter A. J. Stevens, Koen Pardon, Aline De Vleminck, Kim Beernaert
Abstract
Background
Patients with advanced cancer participating in phase I clinical trials often face limited survival while experiencing significant symptom burden. Despite evidence supporting early palliative care integration alongside active cancer treatment to improve quality of life, the role of palliative care in phase I trials remains unclear.
Introduction
Patients with advanced cancer who have exhausted standard treatment options can be offered participation in phase I clinical trials [1]. These trials primarily focus on evaluating the toxicity and appropriate dosing of novel therapies, unlike phase II and phase III trials which assess therapeutic efficacy [2].
Method
Study design
This study employed a qualitative descriptive research design using semi-structured face-to-face interviews [19]. A qualitative descriptive design was chosen as it allows for the in-depth studying of unexplored topics, with semi-structured interviews allowing flexibility for the uncovering of potentially unforeseen topics related to the research questions. We applied a multi-perspective essentialist approach, prioritizing a broader data collection of multiple types of participants over a more idiosyncratic hermeneutical interpretative approach [20].
Results
A total of 48 participants were interviewed: sixteen patients, five informal caregivers, twelve phase I staff, six oncologists, five palliative care specialists, and four GPs. Participants characteristics are displayed in Table 2. Cancer types and stages varied across participating patients. Phase I staff members held a diverse range of roles, including four physician-investigators, two heads of department, three nurses, and three study coordinators.
Discussion
This qualitative multiperspective interview study explored the current attention to quality of life in care for phase I oncological trial participants, the current role of palliative care, and the possibilities for better integrating palliative care in phase I oncological trials, from the perspectives of patients, informal caregivers, and various healthcare providers. Our findings indicate that palliative care is not systematically integrated into phase I trial settings in Belgium.
Acknowledgments
We wish to thank Marthe Tulpin, Roselynn De Roeck, and Ruth Coussement for their help with conducting interviews, as well as the study coordinators of the Drug Research Unit Ghent and University Center for Clinical Research Antwerp for their help with data collection.
Citation: Daenen F, van Driessche A, Scherrens A-L, Janssens A, Rottey S, Decoster L, et al. (2026) Integration of palliative care into phase I oncology trials: A qualitative interview study with patients, informal caregivers, and healthcare providers. PLoS One 21(5): e0347349. https://doi.org/10.1371/journal.pone.0347349
Editor: JONATHAN BAYUO, The Hong Kong Polytechnic University, HONG KONG
Received: July 18, 2025; Accepted: March 30, 2026; Published: May 5, 2026
Copyright: © 2026 Daenen et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Data Availability: The data underlying this study consist of qualitative interview transcripts containing potentially identifying and sensitive information from patients, family caregivers, and healthcare professionals. In accordance with the approval conditions of the Medical Ethics Committee of UZ Brussel/VUB, these data cannot be shared publicly to protect participant confidentiality. Pseudonymized excerpts relevant to the findings can be shared upon reasonable request. Data requests may be sent to either the first author or the Medical Ethics Committee of UZ Brussel/VUB (Ethiek@uzbrussel.be). Any data sharing will only occur after formal approval from the Ethics Committee and in accordance with applicable data protection regulations.
Funding: Project funded by Kom op tegen Kanker (Stand up to Cancer), the Flemish cancer society (13719) (URL: https://www.komoptegenkanker.be/). This grant was awarded to author KB. The funder had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests: The authors have declared that no competing interests exist.
