{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T20:00:49Z","timestamp":1790280049989,"version":"4.1.0"},"reference-count":11,"publisher":"SAGE Publications","issue":"11","license":[{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T00:00:00Z","timestamp":1761696000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"funder":[{"name":"BMISR","award":["P30CA023074"],"award-info":[{"award-number":["P30CA023074"]}]},{"name":"National Cancer Institute, Division of Cancer Prevention, NCORP Research Base","award":["UG1CA189974"],"award-info":[{"award-number":["UG1CA189974"]}]},{"name":"Agency of Healthcare Research and Quality","award":["HS021491"],"award-info":[{"award-number":["HS021491"]}]}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Am J Hosp Palliat Care"],"published-print":{"date-parts":[[2026,11]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Malignant bowel obstruction (MBO) is a complex clinical entity and there remains a relative lack of high-quality comparative trials on surgical management, in part due to a heterogeneous patient population and different treatment modalities which contribute to challenges in trial design and completion. SWOG S1316 is the only prospective randomized trial evaluating surgical vs non-surgical management of MBO and involved a trial framework in which patients were recruited for a randomization pathway as well as a patient choice pathway. Importantly, successful completion of S1316 required numerous amendment modifications to the trial during its course. We aimed to highlight aspects of S1316 trial design, execution, and modification that potentially contributed to trial completion.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Iterative qualitative content analysis of trial modification amendments through the course of the trial from 2015 to 2020.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>133 unique amendments were made to S1316 from 2015 to 2020. We found four dominant domains for the amendments: Accrual Barriers, Study Design Changes, Data Collection Issues, and Clarifications. Accrual amendments were essential to completing the trial and included increasing participating sites from six to 30 (including international sites) and the inclusion of Spanish-speaking participants (11% of final study population).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Content analysis of S1316 trial amendments highlighted that Accrual amendments were important in trial completion. Future investigators may benefit from better anticipating trial modifications as they design their studies. It is likely that rapid initiation of trial amendments can lead to improved accrual and study completion.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1177\/10499091251391420","type":"journal-article","created":{"date-parts":[[2025,10,29]],"date-time":"2025-10-29T09:05:44Z","timestamp":1761728744000},"page":"1238-1243","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":0,"title":["Optimizing Palliative Cancer Surgery Trial Completion: Lessons Learned From Qualitative Content Analysis of S1316 \u2013 Comparative Effectiveness Trial for Malignant Bowel Obstruction"],"prefix":"10.1177","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0009-0009-8493-6976","authenticated-orcid":false,"given":"Mohammad Saad","family":"Farooq","sequence":"first","affiliation":[{"name":"Hospital of the University of Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neda","family":"Amini","sequence":"additional","affiliation":[{"name":"Geisinger Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia","family":"Sun","sequence":"additional","affiliation":[{"name":"City of Hope Comprehensive Cancer Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gary B.","family":"Deutsch","sequence":"additional","affiliation":[{"name":"NYU Langone Hospital - Long Island"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremiah L.","family":"Deneve","sequence":"additional","affiliation":[{"name":"University of North Carolina"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marcia","family":"Grant","sequence":"additional","affiliation":[{"name":"City of Hope Comprehensive Cancer Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8162-7179","authenticated-orcid":false,"given":"Kathryn B.","family":"Arnold","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Angeles Alvarez","family":"Secord","sequence":"additional","affiliation":[{"name":"Duke University Health System"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Garnet","family":"Anderson","sequence":"additional","affiliation":[{"name":"Fred Hutchinson Cancer Center"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7176-461X","authenticated-orcid":false,"given":"Robert S.","family":"Krouse","sequence":"additional","affiliation":[{"name":"University of Pennsylvania, Leonard Davis Institute of Health Policy, Cpl. Michael J. Crescenz Veterans Affairs Medical Center"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2025,10,29]]},"reference":[{"key":"e_1_3_5_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.soi.2024.100046"},{"key":"e_1_3_5_3_2","doi-asserted-by":"publisher","DOI":"10.2147\/CMAR.S29297"},{"key":"e_1_3_5_4_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00520-022-06889-8"},{"key":"e_1_3_5_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD002764.pub2"},{"key":"e_1_3_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpainsymman.2007.04.011"},{"key":"e_1_3_5_7_2","doi-asserted-by":"publisher","DOI":"10.1158\/1055-9965.337.13.3"},{"key":"e_1_3_5_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/S2468-1253(23)00191-7"},{"key":"e_1_3_5_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.surg.2016.06.026"},{"key":"e_1_3_5_10_2","doi-asserted-by":"publisher","DOI":"10.1177\/1049732305276687"},{"key":"e_1_3_5_11_2","doi-asserted-by":"publisher","DOI":"10.1111\/nhs.12048"},{"key":"e_1_3_5_12_2","doi-asserted-by":"publisher","DOI":"10.1177\/1049909119851471"}],"container-title":["American Journal of Hospice and Palliative Medicine\u00ae"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10499091251391420","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1177\/10499091251391420","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1177\/10499091251391420","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,9,24]],"date-time":"2026-09-24T19:19:36Z","timestamp":1790277576000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1177\/10499091251391420"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,29]]},"references-count":11,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2026,11]]}},"alternative-id":["10.1177\/10499091251391420"],"URL":"https:\/\/doi.org\/10.1177\/10499091251391420","relation":{},"ISSN":["1049-9091","1938-2715"],"issn-type":[{"value":"1049-9091","type":"print"},{"value":"1938-2715","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,29]]}}}