{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T23:20:56Z","timestamp":1791588056752,"version":"4.3.4"},"reference-count":50,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2025,8,14]],"date-time":"2025-08-14T00:00:00Z","timestamp":1755129600000},"content-version":"unspecified","delay-in-days":13,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["K08CA263549"],"award-info":[{"award-number":["K08CA263549"]}],"id":[{"id":"10.13039\/100000054","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,7,18]]},"published-print":{"date-parts":[[2025,8]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Patients with metastatic oncogene-driven non-small cell lung cancer (NSCLC) are experiencing longer and uncertain trajectories of life-limiting illness due to advances in precision medicine. These advanced cancer survivors face new challenges related to living with uncertainty and desire more support to maximize their health and quality of life. Therefore, we developed a population-specific, blended palliative and survivorship care intervention to address the supportive care needs of patients recently diagnosed with advanced lung cancer and who are receiving targeted therapy for NSCLC with\n                      <jats:italic>EGFR<\/jats:italic>\n                      ,\n                      <jats:italic>ALK<\/jats:italic>\n                      ,\n                      <jats:italic>ROS1<\/jats:italic>\n                      or\n                      <jats:italic>RET<\/jats:italic>\n                      driver mutations.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>This study is a single-site, non-blinded pilot randomised controlled trial of an intervention for patients with metastatic oncogene-driven NSCLC, Patient-centred, Optimal Integration of Survivorship and palliative carE (POISE) versus usual care. POISE consists of a brief series of structured visits with a trained palliative care clinician to address coping with uncertainty, increase prognostic awareness and promote healthy lifestyle behaviours. We will recruit 60 patients from the Massachusetts General Hospital Cancer Center. Patients will be randomised into a 1:1 ratio to the intervention arm or the usual care arm. Patients randomised to the intervention arm will complete four 60\u2009min virtual or in-person visits with a palliative care physician. The usual care arm will receive standard oncology care. Patients in both arms will complete survey assessments at enrolment, 12 weeks and 20 weeks after enrolment, and patients in the intervention group will complete an exit interview. The primary outcome measure of this trial is feasibility, which will be defined by \u226560% enrolment among eligible patients, \u226570% completion of all sessions for participants in the intervention arm and \u226570% completion of all surveys for all study participants. Exploratory outcomes include acceptability, emotional coping with prognosis, self-efficacy for chronic disease management, prognostic awareness, quality of life, anxiety, depression, intolerance of uncertainty and documentation of goals and values discussions in the electronic health record.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>This study was approved by the Dana-Farber\/Harvard Cancer Center\u2019s institutional review board (protocol 20-722). The protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines, and the study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial \" xlink:href=\"NCT04900935\">NCT04900935<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-098075","type":"journal-article","created":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T16:09:16Z","timestamp":1761581356000},"page":"e098075","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"title":["Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"nct04900935","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04900935","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04900935","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Heather A","family":"Richard","sequence":"first","affiliation":[{"name":"College of Medicine, University of Nebraska Medical Center, Omaha, Nebraska, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roshni","family":"Sarathy","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dustin J","family":"Rabideau","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jill","family":"Feldman","sequence":"additional","affiliation":[{"name":"EGFR Resisters, Deerfield, Illinois, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leslie","family":"Cartagena","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Heather","family":"Patel","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lecia V","family":"Sequist","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elyse","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vicki","family":"Jackson","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph A","family":"Greer","sequence":"additional","affiliation":[{"name":"Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jennifer S","family":"Temel","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8721-4858","authenticated-orcid":false,"given":"Laura A","family":"Petrillo","sequence":"additional","affiliation":[{"name":"Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,8,13]]},"reference":[{"key":"2025102708392469000_15.8.e098075.1","doi-asserted-by":"crossref","DOI":"10.1200\/EDBK_432516","article-title":"New Treatment Options for Patients With Oncogene-Addicted Non-Small Cell Lung Cancer Focusing on EGFR-Mutant Tumors","volume":"44","author":"Saw","year":"2024","journal-title":"Am Soc Clin Oncol Educ Book"},{"key":"2025102708392469000_15.8.e098075.2","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2017.77.4794"},{"key":"2025102708392469000_15.8.e098075.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1214886"},{"key":"2025102708392469000_15.8.e098075.4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1916623"},{"key":"2025102708392469000_15.8.e098075.5","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.45.3753"},{"key":"2025102708392469000_15.8.e098075.6","doi-asserted-by":"crossref","first-page":"1824","DOI":"10.1001\/jamaoncol.2021.4932","article-title":"Update of Incidence, Prevalence, Survival, and Initial Treatment in Patients With Non-Small Cell Lung Cancer in the US","volume":"7","author":"Ganti","year":"2021","journal-title":"JAMA Oncol"},{"key":"2025102708392469000_15.8.e098075.7","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1913662"},{"key":"2025102708392469000_15.8.e098075.8","doi-asserted-by":"crossref","first-page":"3120","DOI":"10.1002\/cncr.34369","article-title":"Prognostic communication about lung cancer in the precision oncology era: A multiple-perspective qualitative study","volume":"128","author":"Petrillo","year":"2022","journal-title":"Cancer"},{"key":"2025102708392469000_15.8.e098075.9","doi-asserted-by":"crossref","first-page":"386","DOI":"10.1007\/s11764-021-01016-8","article-title":"Experience and supportive care needs of metastatic lung cancer survivors living with uncertainty: a brief qualitative report","volume":"15","author":"Petrillo","year":"2021","journal-title":"J Cancer Surviv"},{"key":"2025102708392469000_15.8.e098075.10","doi-asserted-by":"crossref","first-page":"e65","DOI":"10.1016\/j.jpainsymman.2021.02.010","article-title":"Patient-Reported and End-of-Life Outcomes Among Adults with Oncogene-Driven Lung Cancer in a Palliative Care Clinical Trial","volume":"62","author":"Petrillo","year":"2020","journal-title":"J Pain Symptom Manage"},{"key":"2025102708392469000_15.8.e098075.11","doi-asserted-by":"crossref","DOI":"10.6004\/jnccn.2023.7072","article-title":"Lung Cancer Survivorship: Physical, Social, Emotional, and Medical Needs of NSCLC Survivors","volume":"22","author":"Hsu","year":"2024","journal-title":"J Natl Compr Canc Netw"},{"key":"2025102708392469000_15.8.e098075.12","doi-asserted-by":"crossref","first-page":"392","DOI":"10.1007\/s11764-021-01024-8","article-title":"Living with and beyond metastatic non-small cell lung cancer: the survivorship experience for people treated with immunotherapy or targeted therapy","volume":"15","author":"Lai-Kwon","year":"2021","journal-title":"J Cancer Surviv"},{"key":"2025102708392469000_15.8.e098075.13","doi-asserted-by":"publisher","DOI":"10.1002\/pon.6093"},{"key":"2025102708392469000_15.8.e098075.14","unstructured":"Teoli D , Schoo C , Kalish VB . Palliative Care. StatPearls Publishing, 2024. Available: http:\/\/www.ncbi.nlm.nih.gov\/books\/NBK537113"},{"key":"2025102708392469000_15.8.e098075.15","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1000678"},{"key":"2025102708392469000_15.8.e098075.16","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2009.1198"},{"key":"2025102708392469000_15.8.e098075.17","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)62416-2"},{"key":"2025102708392469000_15.8.e098075.18","doi-asserted-by":"crossref","first-page":"53","DOI":"10.1200\/JCO.2017.73.7221","article-title":"Role of Patient Coping Strategies in Understanding the Effects of Early Palliative Care on Quality of Life and Mood","volume":"36","author":"Greer","year":"2018","journal-title":"J Clin Oncol"},{"key":"2025102708392469000_15.8.e098075.19","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.32.4459"},{"key":"2025102708392469000_15.8.e098075.20","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2016.70.5046"},{"key":"2025102708392469000_15.8.e098075.21","doi-asserted-by":"crossref","first-page":"626","DOI":"10.1200\/JCO.21.01710","article-title":"Patient-Centered Palliative Care for Patients With Advanced Lung Cancer","volume":"40","author":"Temel","year":"2022","journal-title":"JCO"},{"key":"2025102708392469000_15.8.e098075.22","doi-asserted-by":"publisher","DOI":"10.1200\/JOP.2014.001403"},{"key":"2025102708392469000_15.8.e098075.23","doi-asserted-by":"crossref","first-page":"3304","DOI":"10.1200\/JCO.22.02212","article-title":"Evolving Landscape of Metastatic Cancer Survivorship: Reconsidering Clinical Care, Policy, and Research Priorities for the Modern Era","volume":"41","author":"Lai-Kwon","year":"2023","journal-title":"JCO"},{"key":"2025102708392469000_15.8.e098075.24","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2012.45.3886"},{"key":"2025102708392469000_15.8.e098075.25","doi-asserted-by":"publisher","DOI":"10.1093\/jnci\/djz089"},{"key":"2025102708392469000_15.8.e098075.26","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-3-201302050-00583"},{"key":"2025102708392469000_15.8.e098075.27","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2204.0023"},{"key":"2025102708392469000_15.8.e098075.28","doi-asserted-by":"publisher","DOI":"10.1016\/j.jbi.2008.08.010"},{"key":"2025102708392469000_15.8.e098075.29","doi-asserted-by":"publisher","DOI":"10.1080\/15424065.2016.1259026"},{"key":"2025102708392469000_15.8.e098075.30","doi-asserted-by":"publisher","DOI":"10.1111\/j.1547-5069.1990.tb00225.x"},{"key":"2025102708392469000_15.8.e098075.31","doi-asserted-by":"publisher","DOI":"10.1007\/s10865-016-9782-2"},{"key":"2025102708392469000_15.8.e098075.32","doi-asserted-by":"crossref","first-page":"2594","DOI":"10.1002\/pon.4880","article-title":"Towards the validation of a new, blended theoretical model of fear of cancer recurrence","volume":"27","author":"Lebel","year":"2018","journal-title":"Psychooncology"},{"key":"2025102708392469000_15.8.e098075.33","doi-asserted-by":"crossref","first-page":"663","DOI":"10.1007\/s11764-015-0512-5","article-title":"Fear of cancer recurrence: a theoretical review and novel cognitive processing formulation","volume":"10","author":"Fardell","year":"2016","journal-title":"J Cancer Surviv"},{"key":"2025102708392469000_15.8.e098075.34","doi-asserted-by":"crossref","first-page":"e787","DOI":"10.1200\/JOP.18.00787","article-title":"Fear of Cancer Recurrence: A Model Examination of Physical Symptoms, Emotional Distress, and Health Behavior Change","volume":"15","author":"Hall","year":"2019","journal-title":"J Oncol Pract"},{"key":"2025102708392469000_15.8.e098075.35","doi-asserted-by":"crossref","first-page":"136","DOI":"10.6004\/jnccn.2021.7040","article-title":"Randomized Trial of a Palliative Care Intervention to Improve End-of-Life Care Discussions in Patients With Metastatic Breast Cancer","volume":"20","author":"Greer","year":"2022","journal-title":"J Natl Compr Canc Netw"},{"key":"2025102708392469000_15.8.e098075.36","doi-asserted-by":"crossref","first-page":"784","DOI":"10.6004\/jnccn.2019.0034","article-title":"NCCN Guidelines Insights: Survivorship, Version 2.2019","volume":"17","author":"Sanft","year":"2019","journal-title":"J Natl Compr Canc Netw"},{"key":"2025102708392469000_15.8.e098075.37","doi-asserted-by":"publisher","DOI":"10.1200\/jco.24.00542"},{"key":"2025102708392469000_15.8.e098075.38","doi-asserted-by":"crossref","first-page":"445","DOI":"10.1089\/jpm.2021.0238","article-title":"Development of a Prognostic Awareness Impact Scale for Patients with Advanced Cancer","volume":"25","author":"Brenner","year":"2022","journal-title":"J Palliat Med"},{"key":"2025102708392469000_15.8.e098075.39","doi-asserted-by":"publisher","DOI":"10.1016\/j.jclinepi.2014.06.009"},{"key":"2025102708392469000_15.8.e098075.40","doi-asserted-by":"publisher","DOI":"10.1016\/j.janxdis.2006.03.014"},{"key":"2025102708392469000_15.8.e098075.41","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0447.1983.tb09716.x"},{"key":"2025102708392469000_15.8.e098075.42","doi-asserted-by":"publisher","DOI":"10.1037\/0022-3514.70.2.321"},{"key":"2025102708392469000_15.8.e098075.43","doi-asserted-by":"crossref","first-page":"389","DOI":"10.1016\/j.hoc.2005.02.009","article-title":"Quality of life in lung cancer: the validity and cross-cultural applicability of the Functional Assessment Of Cancer Therapy-Lung scale","volume":"19","author":"Butt","year":"2005","journal-title":"Hematol Oncol Clin North Am"},{"key":"2025102708392469000_15.8.e098075.44","first-page":"3","article-title":"MACRA Palliative Care Quality Measure Development\u2014Testing Summary Report","volume":"9","author":"Ahluwalia","year":"2022","journal-title":"Rand Health Q"},{"key":"2025102708392469000_15.8.e098075.45","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2015.10.018"},{"key":"2025102708392469000_15.8.e098075.46","doi-asserted-by":"crossref","first-page":"591","DOI":"10.6004\/jnccn.2019.7386","article-title":"Pilot Randomized Trial of a Transdisciplinary Geriatric and Palliative Care Intervention for Older Adults With Cancer","volume":"18","author":"Nipp","year":"2020","journal-title":"J Natl Compr Canc Netw"},{"key":"2025102708392469000_15.8.e098075.47","doi-asserted-by":"publisher","DOI":"10.1016\/J.JPAINSYMMAN.2020.08.024"},{"key":"2025102708392469000_15.8.e098075.48","doi-asserted-by":"publisher","DOI":"10.1037\/0033-2909.112.1.155"},{"key":"2025102708392469000_15.8.e098075.49","doi-asserted-by":"crossref","first-page":"3691","DOI":"10.1002\/cncr.33683","article-title":"Validating the Patient-Reported Outcomes Measurement Information System Short Form v1.0-Anxiety 8a in a sample of young adult cancer survivors: Comparison with a structured clinical diagnostic interview","volume":"127","author":"Recklitis","year":"2021","journal-title":"Cancer"},{"key":"2025102708392469000_15.8.e098075.50","doi-asserted-by":"crossref","first-page":"1568","DOI":"10.1002\/cncr.32689","article-title":"Screening young adult cancer survivors with the PROMIS Depression Short Form (PROMIS-D-SF): Comparison with a structured clinical diagnostic interview","volume":"126","author":"Recklitis","year":"2020","journal-title":"Cancer"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-098075","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,27]],"date-time":"2025-10-27T16:09:20Z","timestamp":1761581360000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-098075"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,8]]},"references-count":50,"journal-issue":{"issue":"8","published-online":{"date-parts":[[2025,8,13]]},"published-print":{"date-parts":[[2025,8]]}},"alternative-id":["10.1136\/bmjopen-2024-098075"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-098075","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,8]]}}}