A Novel Intervention for Patients With Cancer

Completed · Not applicable

Conditions studied: Substance Use, Cancer, Psychological

In brief

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.

Key facts

Study ID: NCT05643027
Run by: Dana-Farber Cancer Institute
People needed: 40
Starts: 2023-03-01
Expected to finish: 2026-05-11
Last updated by the study team: 2026-05-14

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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]

You may not qualify if…

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.

Where it is running

Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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