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NCT05643027
A Novel Intervention for Patients With Cancer
Conditions: Substance Use, Cancer, Psychological
Sex: All
Ages: 18 Years – 99 Years
Phase: NA
Enrollment: 20
Sponsor: Dana-Farber Cancer Institute
Location: United States
Summary
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 memoriesThe 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)QuestionnairesPost-study interviewConsistent 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.
Eligibility Criteria
Inclusion Criteria:at least 18 years oldhave 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 malignanciesperformance 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]Exclusion Criteria: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 therapynot meet criteria for current substance use disorderassessed 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.
Source: ClinicalTrials.gov (NCT05643027). StuddyBuddy aggregates publicly available trial information.