BMJ open · 2024
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.
Протокол клинического исследованияСтатьяНазвание и аннотация: Перевод в очереди
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Yusufov Miryam, Pirl William F, Greer Joseph A, Mazzola Emanuele, Dalrymple Kristy L, Tulsky James A, Braun Ilana M, McHugh R Kathryn
Аннотация
INTRODUCTION: 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)).
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT05643027.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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.
TRIAL REGISTRATION NUMBER: NCT05643027.