Clinical trial NCT04963972: Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery
Official title: Impact of Digital and Behavioral Tele-Health Tapering Program for Perioperative Surgical Patients Exposed to Opioids
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malignant Abdominal Neoplasm
Malignant Head and Neck Neoplasm
Malignant Solid Neoplasm
Malignant Thoracic Neoplasm
Lead sponsor: Lucid Lane, Inc
Sponsor class: INDUSTRY
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2021-07-15
Enrollment: 272
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the impact of Lucid Lane's perioperative opioid tapering program utilizing daily behavioral health support (Health Insurance Portability and Accountability Act \[HIPAA\]-compliant sessions of cognitive behavioral therapy \[CBT\], mindfulness, 1:1 psychotherapy, group therapy, and 2-way texting and chat, all interactions with Lucid Lane licensed therapists), for patients who are on an opioid medication prior to surgery (tolerant), or naive and will be undergoing a surgery with curative intent post-surgery.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: 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.

ARM II: Patients receive standard of care post-surgical opioid education.

Eligibility criteria: 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

Primary outcomes:
measure: Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid naive)
timeFrame: Up to 90 days
measure: Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid tolerant)
timeFrame: Up to 270 days
Secondary outcomes:
measure: Change in quality of life measures between telehealth group and usual care
timeFrame: Baseline up to 9 months
measure: Change in emotional well-being (EWB) between telehealth group and usual care
timeFrame: Baseline up to 9 months
measure: Change in pain assessment between telehealth group and usual care
timeFrame: Baseline up to 9 months
measure: Change in satisfaction between telehealth group and usual care
timeFrame: Baseline up to 9 months
measure: Incidence of adverse events
timeFrame: Up to 9 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lakshmi Koyyalagunta
role: PRINCIPAL_INVESTIGATOR
References: