{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T18:13:25Z","timestamp":1778004805559,"version":"3.51.4"},"reference-count":45,"publisher":"Public Library of Science (PLoS)","issue":"5","license":[{"start":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T00:00:00Z","timestamp":1777939200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100011851","name":"Kom op tegen Kanker","doi-asserted-by":"publisher","award":["13719"],"award-info":[{"award-number":["13719"]}],"id":[{"id":"10.13039\/501100011851","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"\n Background<\/jats:title>\n 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.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To explore perspectives of patients, informal caregivers, and healthcare providers on quality of life and palliative care in phase I oncology trials, including perceived benefits, barriers, and integration strategies.<\/jats:p>\n <\/jats:sec>\n \n Methods<\/jats:title>\n We conducted a multi-perspective qualitative interview study across three Belgian university hospitals from September 2022 to July 2024, using convenience and snowball sampling. The semi-structured interviews were analyzed using qualitative content analysis. Ethical approval was gained from the relevant institutions.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n Participants included sixteen patients, five informal caregivers, twelve phase I staff, six oncologists, five palliative care specialists, and four general practitioners. Patients generally reported positive experiences with trial participation, often viewing it as a final opportunity that provided hope and structure. However, quality of life support was inconsistently addressed and largely reactive. While patients reported feeling supported, non-trial providers and caregivers noted limited person-centered care. No systematic approach for introducing palliative care was in place. Palliative care was rarely discussed, hindered by misconceptions such as equating palliative care with terminal care, reluctance from patients and clinicians, and lack of communication between providers. Participants suggested the introduction of routine yet flexible palliative care conversations, as well as improved communication between providers, as strategies towards integration.<\/jats:p>\n <\/jats:sec>\n \n Conclusion<\/jats:title>\n Despite recognized care needs, palliative care is not systematically integrated in phase I oncological trials. Quality of life remains a secondary concern. Integrating palliative care in a structured yet flexible manner could support more holistic, patient-centered care. These findings underscore the need to normalize palliative care as a complementary component of phase I oncological trials.<\/jats:p>\n <\/jats:sec>","DOI":"10.1371\/journal.pone.0347349","type":"journal-article","created":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T17:39:08Z","timestamp":1778002748000},"page":"e0347349","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Integration of palliative care into phase I oncology trials: A qualitative interview study with patients, informal caregivers, and healthcare providers"],"prefix":"10.1371","volume":"21","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0657-5468","authenticated-orcid":true,"given":"Frederick","family":"Daenen","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"van Driessche","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Lore","family":"Scherrens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Annelies","family":"Janssens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sylvie","family":"Rottey","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lore","family":"Decoster","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter A. J.","family":"Stevens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Koen","family":"Pardon","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aline","family":"De Vleminck","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kim","family":"Beernaert","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"340","published-online":{"date-parts":[[2026,5,5]]},"reference":[{"issue":"2","key":"pone.0347349.ref001","doi-asserted-by":"crossref","first-page":"185","DOI":"10.1089\/jpm.2024.0147","article-title":"Regret in clinical trial participation among cancer patients","volume":"28","author":"KM Baker","year":"2025","journal-title":"J Palliat Med"},{"issue":"6","key":"pone.0347349.ref002","article-title":"Self-reported quality of life and hope in phase-I trial participants: An observational prospective cohort study","volume":"27","author":"DA van der Biessen","year":"2018","journal-title":"Eur J Cancer Care (Engl)"},{"key":"pone.0347349.ref003","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ejca.2023.04.006","article-title":"Profile and outcome of cancer patients enrolled in contemporary phase I trials","volume":"188","author":"E Alouani","year":"2023","journal-title":"Eur J Cancer"},{"issue":"2","key":"pone.0347349.ref004","doi-asserted-by":"crossref","first-page":"449","DOI":"10.1007\/s00280-019-03992-2","article-title":"Improved survival among patients enrolled in oncology phase 1 trials in recent decades","volume":"85","author":"T Ebata","year":"2020","journal-title":"Cancer Chemother Pharmacol"},{"issue":"1","key":"pone.0347349.ref005","first-page":"49","article-title":"A qualitative assessment of the experience of participating in a cancer-related clinical trial","volume":"19","author":"AC Wootten","year":"2011","journal-title":"Support Care Cancer"},{"key":"pone.0347349.ref006","doi-asserted-by":"crossref","first-page":"437","DOI":"10.1016\/j.jpainsymman.2016.02.014","article-title":"Phase I cancer trials and palliative care: antagonism, irrelevance, or synergy?","volume":"52","author":"JB Cassel","year":"2016","journal-title":"J Pain Symptom Manage"},{"issue":"18","key":"pone.0347349.ref007","doi-asserted-by":"crossref","first-page":"4402","DOI":"10.1002\/cncr.25389","article-title":"Timing of palliative care referral and symptom burden in phase 1 cancer patients","volume":"116","author":"D Hui","year":"2010","journal-title":"Cancer"},{"issue":"2","key":"pone.0347349.ref008","doi-asserted-by":"crossref","first-page":"446","DOI":"10.1002\/cncr.24025","article-title":"Do phase 1 patients have greater needs for palliative care compared with other cancer patients?","volume":"115","author":"E Finlay","year":"2009","journal-title":"Cancer"},{"issue":"6","key":"pone.0347349.ref009","doi-asserted-by":"crossref","first-page":"846","DOI":"10.1089\/jpm.2020.0597","article-title":"A Palliative Care Intervention for Patients on Phase 1 Studies","volume":"24","author":"B Ferrell","year":"2021","journal-title":"J Palliat Med"},{"key":"pone.0347349.ref010","doi-asserted-by":"crossref","first-page":"101022","DOI":"10.1016\/j.currproblcancer.2023.101022","article-title":"Palliative care integration for patients on phase I cancer clinical trials","author":"A-CR Uhelski","year":"2023","journal-title":"Curr Probl Cancer"},{"issue":"25","key":"pone.0347349.ref011","doi-asserted-by":"crossref","first-page":"4013","DOI":"10.1200\/JCO.2010.29.5618","article-title":"Integrating supportive and palliative care in the trajectory of cancer: establishing goals and models of care","volume":"28","author":"E Bruera","year":"2010","journal-title":"J Clin Oncol"},{"key":"pone.0347349.ref012","author":"World Health Organization","year":"2023"},{"issue":"8","key":"pone.0347349.ref013","doi-asserted-by":"crossref","first-page":"733","DOI":"10.1056\/NEJMoa1000678","article-title":"Early palliative care for patients with metastatic non-small-cell lung cancer","volume":"363","author":"JS Temel","year":"2010","journal-title":"N Engl J Med"},{"issue":"7","key":"pone.0347349.ref014","doi-asserted-by":"crossref","first-page":"741","DOI":"10.1001\/jama.2009.1198","article-title":"Effects of a Palliative Care Intervention on Clinical Outcomes in Patients With Advanced Cancer","volume":"302","author":"M Bakitas","year":"2009","journal-title":"JAMA"},{"issue":"9930","key":"pone.0347349.ref015","doi-asserted-by":"crossref","first-page":"1721","DOI":"10.1016\/S0140-6736(13)62416-2","article-title":"Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial","volume":"383","author":"C Zimmermann","year":"2014","journal-title":"Lancet"},{"key":"pone.0347349.ref016","doi-asserted-by":"crossref","first-page":"186","DOI":"10.1016\/j.ejca.2019.11.009","article-title":"The effect of early and systematic integration of palliative care in oncology on quality of life and health care use near the end of life: A randomised controlled trial","volume":"124","author":"G Vanbutsele","year":"2020","journal-title":"Eur J Cancer"},{"issue":"5","key":"pone.0347349.ref017","first-page":"356","article-title":"Improving patient and caregiver outcomes in oncology: Team-based, timely, and targeted palliative care","volume":"68","author":"D Hui","year":"2018","journal-title":"CA Cancer J Clin"},{"issue":"9","key":"pone.0347349.ref018","first-page":"3873","article-title":"What are the barriers faced by medical oncologists in initiating discussion of palliative care? A qualitative study in Flanders, Belgium","volume":"24","author":"M Horlait","year":"2016","journal-title":"Support Care Cancer"},{"issue":"1","key":"pone.0347349.ref019","doi-asserted-by":"crossref","first-page":"23","DOI":"10.1002\/nur.21768","article-title":"Characteristics of Qualitative Descriptive Studies: A Systematic Review","volume":"40","author":"H Kim","year":"2017","journal-title":"Res Nurs Health"},{"issue":"3","key":"pone.0347349.ref020","doi-asserted-by":"crossref","first-page":"398","DOI":"10.1111\/nhs.12048","article-title":"Content analysis and thematic analysis: Implications for conducting a qualitative descriptive study","volume":"15","author":"M Vaismoradi","year":"2013","journal-title":"Nurs Health Sci"},{"issue":"6","key":"pone.0347349.ref021","doi-asserted-by":"crossref","first-page":"349","DOI":"10.1093\/intqhc\/mzm042","article-title":"Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups","volume":"19","author":"A Tong","year":"2007","journal-title":"Int J Qual Health Care"},{"issue":"5","key":"pone.0347349.ref022","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1177\/0269216307078503","article-title":"The role of general practitioners in continuity of care at the end of life: a qualitative study of terminally ill patients and their next of kin","volume":"21","author":"E Michiels","year":"2007","journal-title":"Palliat Med"},{"key":"pone.0347349.ref023","volume-title":"Nvivo","author":"Lumivero","year":"2023"},{"issue":"7","key":"pone.0347349.ref024","doi-asserted-by":"crossref","first-page":"905","DOI":"10.1177\/1049732303253488","article-title":"Classifying the findings in qualitative studies","volume":"13","author":"M Sandelowski","year":"2003","journal-title":"Qual Health Res"},{"key":"pone.0347349.ref025","article-title":"Analysing qualitative data.","volume-title":"Qualitative Methods for Health Research","author":"J Green","year":"2004","edition":"1"},{"key":"pone.0347349.ref026","volume-title":"Qualitative data analysis: key approaches","author":"P. Stevens","year":"2022"},{"key":"pone.0347349.ref027","doi-asserted-by":"crossref","first-page":"1277","DOI":"10.1177\/1049732305276687","article-title":"Three Approaches to Qualitative Content Analysis","volume":"15","author":"HF Hsieh","year":"2005","journal-title":"Qual Health Res"},{"key":"pone.0347349.ref028","volume-title":"Qualitative content analysis: A step-by-step guide","author":"P Mayring","year":"2021"},{"issue":"2","key":"pone.0347349.ref029","doi-asserted-by":"crossref","first-page":"113","DOI":"10.1097\/01.NNR.0000313482.33917.7d","article-title":"From text to codings: intercoder reliability assessment in qualitative content analysis","volume":"57","author":"L Burla","year":"2008","journal-title":"Nurs Res"},{"key":"pone.0347349.ref030","doi-asserted-by":"crossref","first-page":"37","DOI":"10.1177\/001316446002000104","article-title":"A Coefficient of Agreement for Nominal Scales","volume":"20","author":"J Cohen","year":"1960","journal-title":"Educ Psychol Meas"},{"issue":"2","key":"pone.0347349.ref031","doi-asserted-by":"crossref","first-page":"132","DOI":"10.1016\/j.jpainsymman.2005.02.014","article-title":"When and how to initiate discussion about prognosis and end-of-life issues with terminally ill patients","volume":"30","author":"JM Clayton","year":"2005","journal-title":"J Pain Symptom Manage"},{"key":"pone.0347349.ref032","doi-asserted-by":"crossref","first-page":"15","DOI":"10.1186\/1472-684X-11-15","article-title":"After you: conversations between patients and healthcare professionals in planning for end of life care","volume":"11","author":"K Almack","year":"2012","journal-title":"BMC Palliat Care"},{"issue":"1","key":"pone.0347349.ref033","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1634\/theoncologist.2014-0031","article-title":"What keeps oncologists from addressing palliative care early on with incurable cancer patients? An active stance seems key","volume":"20","author":"TA Pfeil","year":"2015","journal-title":"Oncologist"},{"issue":"1090","key":"pone.0347349.ref034","doi-asserted-by":"crossref","first-page":"466","DOI":"10.1136\/postgradmedj-2015-133368","article-title":"Communication in palliative care: talking about the end of life, before the end of life","volume":"92","author":"LJ Brighton","year":"2016","journal-title":"Postgrad Med J"},{"issue":"2","key":"pone.0347349.ref035","doi-asserted-by":"crossref","first-page":"257","DOI":"10.1177\/02692163221137105","article-title":"Motivations and experiences of patients with advanced cancer participating in Phase 1 clinical trials: A qualitative study","volume":"37","author":"GM Yang","year":"2023","journal-title":"Palliat Med"},{"issue":"1","key":"pone.0347349.ref036","doi-asserted-by":"crossref","first-page":"409","DOI":"10.1186\/s13063-022-06306-9","article-title":"Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences","volume":"23","author":"K Escritt","year":"2022","journal-title":"Trials"},{"issue":"13","key":"pone.0347349.ref037","doi-asserted-by":"crossref","first-page":"4312","DOI":"10.1002\/cam4.3971","article-title":"A randomized controlled trial of structured palliative care versus standard supportive care for patients enrolled in phase 1 clinical trials","volume":"10","author":"M Treasure","year":"2021","journal-title":"Cancer Med"},{"issue":"2","key":"pone.0347349.ref038","doi-asserted-by":"crossref","first-page":"234","DOI":"10.1136\/bmjspcare-2019-001919","article-title":"Phase I cancer trials: a qualitative study of specialist palliative care","volume":"10","author":"S Bellhouse","year":"2020","journal-title":"BMJ Support Palliat Care"},{"issue":"7","key":"pone.0347349.ref039","doi-asserted-by":"crossref","first-page":"955","DOI":"10.1080\/03007995.2023.2224164","article-title":"Patient-reported outcomes validated in phase 3 clinical trials: a targeted literature review","volume":"39","author":"A Morga","year":"2023","journal-title":"Curr Med Res Opin"},{"key":"pone.0347349.ref040","doi-asserted-by":"crossref","DOI":"10.2196\/64611","article-title":"Leveraging Patient-Reported Outcome Measures for Optimal Dose Selection in Early Phase Cancer Trials","volume":"11","author":"B Byrom","year":"2025","journal-title":"JMIR Cancer"},{"key":"pone.0347349.ref041","doi-asserted-by":"crossref","first-page":"102838","DOI":"10.1016\/j.eclinm.2024.102838","article-title":"Advancing patient-centric care: integrating patient reported outcomes for tolerability assessment in early phase clinical trials - insights from an expert virtual roundtable","volume":"76","author":"C Yap","year":"2024","journal-title":"EClinicalMedicine"},{"issue":"12","key":"pone.0347349.ref042","doi-asserted-by":"crossref","first-page":"3299","DOI":"10.1007\/s11136-024-03772-3","article-title":"Truth and dare: patients dare to tell the truth when using PROMs in clinical practice","volume":"33","author":"L Haverman","year":"2024","journal-title":"Qual Life Res"},{"issue":"4","key":"pone.0347349.ref043","doi-asserted-by":"crossref","first-page":"357","DOI":"10.1016\/j.annonc.2021.12.010","article-title":"The use of patient-reported outcomes (PROs) in cancer care: a realistic strategy","volume":"33","author":"E Minvielle","year":"2022","journal-title":"Ann Oncol"},{"key":"pone.0347349.ref044","doi-asserted-by":"crossref","first-page":"156","DOI":"10.1016\/j.conctc.2017.09.009","article-title":"Qualitative analysis of clinical research coordinators\u2019 role in phase I cancer clinical trials","volume":"8","author":"N Fujiwara","year":"2017","journal-title":"Contemp Clin Trials Commun"},{"issue":"9930","key":"pone.0347349.ref045","doi-asserted-by":"crossref","first-page":"1699","DOI":"10.1016\/S0140-6736(13)62676-8","article-title":"A need for scalable outpatient palliative care interventions","volume":"383","author":"SD Block","year":"2014","journal-title":"Lancet"}],"container-title":["PLOS One"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0347349","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T17:39:15Z","timestamp":1778002755000},"score":1,"resource":{"primary":{"URL":"https:\/\/dx.plos.org\/10.1371\/journal.pone.0347349"}},"subtitle":[],"editor":[{"given":"JONATHAN","family":"BAYUO","sequence":"first","affiliation":[],"role":[{"role":"editor","vocabulary":"crossref"}]}],"short-title":[],"issued":{"date-parts":[[2026,5,5]]},"references-count":45,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2026,5,5]]}},"URL":"https:\/\/doi.org\/10.1371\/journal.pone.0347349","relation":{},"ISSN":["1932-6203"],"issn-type":[{"value":"1932-6203","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,5,5]]}}}