Yusufov Miryam, Pirl William F, Greer Joseph A, Mazzola Emanuele, Dalrymple Kristy L, Tulsky James A, Braun Ilana M, McHugh R Kathryn
Department of Supportive Oncology, Dana-Farber Cancer Institute, Boston, Massachusetts, USA
Harvard Medical School, Boston, Massachusetts, USA.
BMJ Open. 2024 Dec 5;14(12):e096546. doi: 10.1136/bmjopen-2024-096546.
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)).
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 ≥60% and a retention rate of >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 weeks. 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 (±2 weeks), following baseline.
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.
NCT05643027.
阿片类药物治疗通常是癌症护理期间疼痛管理的核心。然而，阿片类药物暴露和未解决的心理痛苦共同增加了阿片类药物使用障碍的风险。因此，我们反复开发了一种行为干预措施，由个体实施，以降低癌症护理期间阿片类药物使用障碍的风险（必要时使用阿片类药物的接受与承诺疗法干预（ACTION））。
这是一项单中心、非盲、随机对照试验，将ACTION与等待名单对照组进行比较。本研究的目的是检验ACTION的可行性（定义为总入组率≥60%且保留率>75%）和可接受性（通过退出访谈中的患者报告反馈和客户满意度问卷-8评分进行评估）（主要结局），并评估参与者报告的抑郁、焦虑和阿片类药物滥用情况的变化（次要结局）。患者将从美国马萨诸塞州波士顿的达纳-法伯癌症研究所招募。完成研究的患者总数将为40名。所有患者将在6周后完成基线和随访测量。随机分配到ACTION组（n=20）的患者将接受心理健康提供者通过远程医疗或面对面方式提供的为期六周、每周一次、每次30分钟的治疗。分配到等待名单对照组（n=20）的患者将在完成基线评估约6周（±2周）后的随访评估时接受该干预。
本研究已获得达纳-法伯/哈佛癌症中心机构审查委员会的批准（协议编号#21-587）。参与者就研究方法提供书面或电子知情同意书，一旦入组，他们可以随时退出研究。研究结果将发表在同行评审期刊上，并在科学会议上展示。
NCT05643027
