{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,16]],"date-time":"2026-03-16T13:18:26Z","timestamp":1773667106914,"version":"3.50.1"},"reference-count":32,"publisher":"BMJ","issue":"12","license":[{"start":{"date-parts":[[2024,12,5]],"date-time":"2024-12-05T00:00:00Z","timestamp":1733356800000},"content-version":"unspecified","delay-in-days":4,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100000054","name":"National Cancer Institute","doi-asserted-by":"publisher","award":["K08 CA 259538; PI: Yusufov"],"award-info":[{"award-number":["K08 CA 259538; PI: Yusufov"]}],"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":[[2024,11,25]]},"published-print":{"date-parts":[[2024,12]]},"abstract":"<jats:sec>\n<jats:title>Introduction<\/jats:title>\n<jats:p>Opioid therapy is often central to pain management during cancer care. However, opioid exposure and unaddressed psychological suffering jointly amplify opioid use disorder risk. Therefore, we iteratively developed a behavioural, individually delivered intervention to mitigate the risk of opioid use disorder during cancer care (Acceptance and Commitment Therapy Intervention when Opioids are Necessary (ACTION)).<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Methods and analysis<\/jats:title>\n<jats:p>This is a single-site, non-blinded, randomised, controlled pilot trial of ACTION compared with a waitlist control group. The aims of this study are to examine the feasibility (defined as an overall enrolment rate of \u226560%\u2009and a retention rate of &gt;75%) and acceptability (assessed via patient-reported feedback in exit interviews and Client Satisfaction Questionnaire-8 ratings) of ACTION (primary outcomes) and to assess changes in participant-reported depression, anxiety and opioid misuse (secondary outcomes). Patients will be recruited from Dana-Farber Cancer Institute (Boston, Massachusetts, USA). The total number of patients completing the study will be 40. All patients will complete baseline and follow-up measures after 6\u2009weeks. Patients randomly assigned to ACTION (n=20) will receive six weekly 30-min sessions delivered by a mental health provider either via telehealth or in-person. Patients assigned to the waitlist control group (n=20) will be offered the intervention on completion of their follow-up assessments, approximately 6 weeks (\u00b12 weeks), following baseline.<\/jats:p>\n<\/jats:sec>\n<jats:sec>\n<jats:title>Ethics and dissemination<\/jats:title>\n<jats:p>This study is approved by the Dana-Farber\/Harvard Cancer Center Institutional Review Board (Protocol #21-587). Participants provide either written or electronic informed consent on study approach and once enrolled, they can withdraw from the study at any time. Results will be published in peer-reviewed journals and presented at scientific meetings.<\/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=\"NCT05643027\">NCT05643027<\/jats:ext-link>\n.\n<\/jats:p>\n<\/jats:sec>","DOI":"10.1136\/bmjopen-2024-096546","type":"journal-article","created":{"date-parts":[[2024,12,9]],"date-time":"2024-12-09T15:51:00Z","timestamp":1733759460000},"page":"e096546","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Study protocol for a pilot randomised controlled trial of a virtually delivered behavioural intervention (ACTION) for adults with cancer at risk for opioid use disorder"],"prefix":"10.1136","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct05643027","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0254-3864","authenticated-orcid":false,"given":"Miryam","family":"Yusufov","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William F","family":"Pirl","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joseph A","family":"Greer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Emanuele","family":"Mazzola","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kristy L.","family":"Dalrymple","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James A","family":"Tulsky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ilana M","family":"Braun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"R. 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