Clinical trial · Interventional
A Novel Intervention for Patients With Cancer
A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Psychological | — | UNRESOLVED | — |
| Substance Use | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- INTERVENTION FOR AVOIDANCE-RELATED OPIOID MISUSE
- description
- Participants will participate in a six-session behavioral intervention, delivered by a licensed clinical psychologist.
- interventionNames
- Behavioral: Acceptance and Commitment Therapy
Primary outcomes (2)
- measure
- Feasibility of the intervention, defined as an enrollment rate of at least 60%
- timeFrame
- 1 year
- description
- enrollment rate of at least 60% and retention rate of at least 75%
- measure
- Acceptability of the intervention, measured by Client Satisfaction Questionnaire (CSQ-8) scores
- timeFrame
- 1 year
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * 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 \[ with 0 indicating that the patient is asymptomatic, 1 that the patient is symptomatic but fully ambulatory, and 2 that the patient is symptomatic and in bed \<50% of the day\] 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 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.
References
Publications (1)
- DERIVEDYusufov M, Pirl WF, Greer JA, Mazzola E, Dalrymple KL, Tulsky JA, Braun IM, McHugh RK. 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. BMJ Open. 2024 Dec 5;14(12):e096546. doi: 10.1136/bmjopen-2024-096546. PMID 39638585