Clinical trial · Interventional
Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery
Impact of Digital and Behavioral Tele-Health Tapering Program for Perioperative Surgical Patients Exposed to Opioids
- 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 clinical trial studies the effect of behavioral health support including tele-health in helping surgical patients taper off of prescription opioid pain medications. "Tapering off" means taking dose amounts of medication that get smaller over time, so that less and less of the drug is used until it is not needed anymore. Researchers want to learn how these techniques may improve a patient's ability to lower or avoid dependence on opioid medications after surgery, and if behavioral therapies may improve quality of life, emotional well-being, and functional status around surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Abdominal Neoplasm | Malignant Abdominal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Head and Neck Neoplasm | Malignant Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Solid Neoplasm | Malignant Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Malignant Thoracic Neoplasm | Malignant Thoracic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Intervention | Behavioral | — | UNRESOLVED |
| Best Practice | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Lucid Lane)
- description
- Patients participate in the Lucid Lane therapy program including working with a mental health therapist on mindfulness, CBT, group therapy, and mind-body therapies for 3-9 months or until the tapering off period is complete.
- interventionNames
- Behavioral: Behavioral Intervention
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Arm II (standard of care)
- description
- Patients receive standard of care post-surgical opioid education.
- interventionNames
- Other: Best Practice
- Other: Questionnaire Administration
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Greater than or equal to 18 years of age * Patients undergoing head and neck cancer surgery, open abdominal surgery, thoracic surgery * Life-expectancy of 270 days or more * Patients who will receive opioids as part of their treatment post-operatively * Perioperative opioid use: * Naive Arm: No opioids 30 days prior to surgery * Tolerant Arm: Use of opioids on 2 or more days/week, for 1 or more months prior to surgery * Patient is willing to use Lucid Lane program to provide behavioral health support perioperative period up to 9 months post-op for tolerant opioid users and 1 month for opioid naive users * Patient is willing to discuss Lucid Lane progress with MD Anderson perioperative team and prescribing clinicians * Patient is willing to sign a Lucid Lane Participant Agreement * Patient is willing to sign an informed consent Exclusion Criteria: * Serious mental illnesses including schizophrenia-spectrum disorders, severe bipolar disorder, and severe major depression * Active suicidal ideations * Patients on methadone, naltrexone, or buprenorphine for treatment of opioid use disorder (i.e. for treatment of addiction, and not for treatment of pain) * Patient unwilling to use or not possessing access to a device that allows for video visits (e.g. a smartphone, tablet, or computer) * Patients who are on end-of-life care * Insufficient ability to use English to participate in the consent process, the intervention or study assessments. The Lucid Lane therapists will be conducting therapy sessions in English, and the ability to understand English is required for the consent process. All questionnaires and surveys will be in English to ensure appropriate and comprehensive care for this patient population * Insufficient ability to provide informed consent to participate
References
Publications (0)
Data not yet available