A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility of the intervention, defined as an enrollment rate of at least 60%
研究概览
简要总结
This research study is being done to develop an intervention for psychological symptoms that patients diagnosed with cancer may experience. Psychological symptoms may include thoughts, feelings, emotions, and memories
The names of the study intervention and research activities involved in this study are/is:
- Acceptance & Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
Consistent with the NIH Stage Model for Behavioral Intervention Development, the investigators have adapted an existing, empirically-validated intervention, Acceptance and Commitment Therapy (ACT), to address substance use disorder risk during cancer care. The core components of ACT are particularly well-suited to address the psychological processes underlying opioid misuse in individuals treated for cancer pain. The overarching aim is to assess the feasibility and acceptability of the intervention by conducting a randomized pilot trial of the revised intervention ("ACTION") for cancer patients on opioid therapy, and at risk for SUD.
详细描述
This research study is a Feasibility Study, which is the first-time investigators are examining this psychological intervention in patients with cancer who are prescribed opioids and are receiving palliative care. This study is being conducted to develop a psychological intervention designed specifically for individuals with cancer. The purpose of this study is to determine how practical this intervention is, to determine patient satisfaction, and test the study procedures. The aims are to:
- determine whether this intervention will be appropriate for further testing;
- identify which parts of the protocol and procedures need to be modified; and
- assess patients' reactions to this intervention.
This research study involves a psychological intervention for thoughts, feelings, emotions, and memories that individuals diagnosed with cancer may have.
The names of the study intervention and research activities involved in this study are/is:
- Acceptance & Commitment Therapy (ACT) for Cancer (involving 6 sessions with a licensed clinical psychologist)
- Questionnaires
- Post-study interview
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •at least 18 years old
- •have an estimated survival time of at least 6 months (as estimated by palliative care provider)
- •score at least 4 on the Opioid Risk Tool (ORT)
- •have been diagnosed with any cancer, including hematologic malignancies
- •performance status criterion of 0, 1, or 2 [ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed <50% of the day]
排除标准
- •Patients with a score at least 3 to ensure that all enrolled patients are able to participate in the intervention, complete assessments, ensure that no patients who are too sick to participate are enrolled; this will enhance the rigor of the study)
- •currently be on opioid therapy
- •not meet criteria for current substance use disorder
- •assessed by the Diagnostic & Statistical Manual of mental disorders; DSM-5 or be receiving substance use disorder treatment; and speak and comprehend English sufficiently to be able to participate in psychotherapy.
研究组 & 干预措施
INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE
Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist.
干预措施: Acceptance and Commitment Therapy (Behavioral)
结局指标
主要结局
Feasibility of the intervention, defined as an enrollment rate of at least 60%
时间窗: 1 year
enrollment rate of at least 60% and retention rate of at least 75%
Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores
时间窗: 1 year
Acceptability of the intervention, measured by CSQ-8 scores and patient reported feedback during exit interviews. On the CSQ-8, some items are reverse scored but higher scores mean greater satisfaction. Min value = 8, max value = 32
次要结局
- Depression, measured by the Patient Health Questionnaire (PHQ-9)(1 year)
- anxiety, as measured by the Generalized Anxiety Disorder questionnaire (GAD-7)(1 year)
- opioid misuse behaviors and consequences, as measured by the Current Opioid Misuse Measure (COMM)(1 year)
研究者
Miryam Yusufov, PhD
Principal Investigator
Dana-Farber Cancer Institute