Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery

NCT04963972 | Unknown DMC

• 2 other identifiers: 2020-0769NCI-2021-00053
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid naive)

  Up to 90 days

• Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid tolerant)

  Up to 270 days

Secondary Outcomes (5)

• Change in quality of life measures between telehealth group and usual care

  Baseline up to 9 months

• Change in emotional well-being (EWB) between telehealth group and usual care

  Baseline up to 9 months

• Change in pain assessment between telehealth group and usual care

  Baseline up to 9 months

• Change in satisfaction between telehealth group and usual care

  Baseline up to 9 months

• Incidence of adverse events

  Up to 9 months

Study Arms (2)

Arm I (Lucid Lane)

EXPERIMENTAL

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.

Behavioral: Behavioral Intervention; Other: Questionnaire Administration

Arm II (standard of care)

ACTIVE COMPARATOR

Patients receive standard of care post-surgical opioid education.

Other: Best Practice; Other: Questionnaire Administration

Interventions

Behavioral Intervention BEHAVIORAL

Participate in Lucid Lane therapy program

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Arm I (Lucid Lane)

Best Practice OTHER

Receive standard of care opioid education

Also known as: standard of care, standard therapy

Arm II (standard of care)

Questionnaire Administration OTHER

Ancillary studies

Arm I (Lucid Lane); Arm II (standard of care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lucid Lane, Inc: lead
• M.D. Anderson Cancer Center: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Behavior Therapy; Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Lakshmi Koyyalagunta

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: July 15, 2021
• Study Start: February 23, 2021
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

US (1)