Recruiting

Tele-Health Tapering

Sponsor:

Lucid Lane, Inc

Code:

NCT04963972

Conditions

Malignant Abdominal Neoplasm

Malignant Head and Neck Neoplasm

Malignant Solid Neoplasm

Malignant Thoracic Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Behavioral Intervention

Best Practice

Questionnaire Administration

Study Details

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.

Conditions

Malignant Abdominal Neoplasm

Malignant Head and Neck Neoplasm

Malignant Solid Neoplasm

Malignant Thoracic Neoplasm

Study ID

NCT04963972

Start date

Feb 23, 2021

Status verified date

May, 2022

Completion date

Feb 1, 2023

Anticipated

Primary completion date

Feb 1, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

272 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm I (Lucid Lane)

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.

active comparator: Arm II (standard of care)

Patients receive standard of care post-surgical opioid education.

Interventions

Behavioral Intervention

Participate in Lucid Lane therapy program

Best Practice

Receive standard of care opioid education

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid naive) [ Time Frame: Up to 90 days ]
  • Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid tolerant) [ Time Frame: Up to 270 days ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Lakshmi Koyyalagunta

713-745-4939dkoyyala@mdanderson.org

Principal Investigator:

Lakshmi Koyyalagunta

More Information

Sponsor

Lucid Lane, Inc

Last update posted

May 10, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Lucid Lane, Inc on 2022-05-10.