A new approach to help cancer patients manage psychological symptoms
A Novel Intervention for Avoidance-Related Opioid Misuse in Patients With Cancer
This study is testing a new therapy to help cancer patients cope with psychological issues and reduce the risk of substance use problems related to their pain medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05643027 on ClinicalTrials.gov |
What this trial studies
This research focuses on developing a psychological intervention using Acceptance and Commitment Therapy (ACT) tailored for cancer patients experiencing psychological symptoms, particularly those at risk for substance use disorders due to opioid prescriptions. The study aims to assess the feasibility and acceptability of this intervention through six sessions with a licensed clinical psychologist, alongside questionnaires and post-study interviews. By evaluating patient satisfaction and the practicality of the intervention, the researchers hope to refine the protocol for future testing. The study will involve approximately 10 participants over a period of up to 2 months.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a cancer diagnosis, an estimated survival time of at least 6 months, and a score of at least 4 on the Opioid Risk Tool.
Not a fit: Patients who are currently on opioid therapy or have a current substance use disorder may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the psychological well-being of cancer patients and reduce the risk of substance misuse.
How similar studies have performed: While this specific approach is novel, similar psychological interventions have shown promise in improving outcomes for patients with chronic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Boston, Massachusetts
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Miryam Yusufov, PhD — Dana-Farber Cancer Institute
- Study coordinator: Miryam Yusufov, PhD
- Email: miryam_yusufov@dfci.harvard.edu
- Phone: (617) 582-7618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.