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

Primary Purpose

Malignant Abdominal Neoplasm, Malignant Head and Neck Neoplasm, Malignant Solid Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral Intervention
Best Practice
Questionnaire Administration
Sponsored by
Lucid Lane, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malignant Abdominal Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (Lucid Lane)

Arm II (standard of care)

Arm 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.

Patients receive standard of care post-surgical opioid education.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in quality of life measures between telehealth group and usual care
Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity, Brief Pain Inventory (BPI) Scale 0 no pain to Scale 10 pain at its worse, Patient Health Questionaire-9 (PHQ-9) Scale score totals: 1-4 minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. EQ-5D-5L The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change in emotional well-being (EWB) between telehealth group and usual care
Generalized Anxiety Disorder 7 item (GAD-7) scale Score totals of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. Further evaluation is recommended when the score is 10 or greater. Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity. Patient Health Questionaire-9 (PHQ-9) 1-4 minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. EQ-5D-5L The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change in pain assessment between telehealth group and usual care
Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity. Brief Pain Inventory (BPI) Scale 0 of no pain to scale 10 pain at its worse.
Change in satisfaction between telehealth group and usual care
Telehealth patient satisfaction survey. Scale range: Poor - Fair - Good - Excellent
Incidence of adverse events

Full Information

First Posted
February 24, 2021
Last Updated
May 4, 2022
Sponsor
Lucid Lane, Inc
Collaborators
M.D. Anderson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04963972
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2021 (Actual)
Primary Completion Date
February 1, 2023 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lucid Lane, Inc
Collaborators
M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Abdominal Neoplasm, Malignant Head and Neck Neoplasm, Malignant Solid Neoplasm, Malignant Thoracic Neoplasm

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
272 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (Lucid Lane)
Arm Type
Experimental
Arm 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.
Arm Title
Arm II (standard of care)
Arm Type
Active Comparator
Arm Description
Patients receive standard of care post-surgical opioid education.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments
Intervention Description
Participate in Lucid Lane therapy program
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Receive standard of care opioid education
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid naive)
Time Frame
Up to 90 days
Title
Percent tapered off of opioid in the telehealth group over time compared to usual care (opioid tolerant)
Time Frame
Up to 270 days
Secondary Outcome Measure Information:
Title
Change in quality of life measures between telehealth group and usual care
Description
Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity, Brief Pain Inventory (BPI) Scale 0 no pain to Scale 10 pain at its worse, Patient Health Questionaire-9 (PHQ-9) Scale score totals: 1-4 minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. EQ-5D-5L The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Baseline up to 9 months
Title
Change in emotional well-being (EWB) between telehealth group and usual care
Description
Generalized Anxiety Disorder 7 item (GAD-7) scale Score totals of 5, 10, and 15 represent cut-points for mild, moderate, and severe anxiety, respectively. Further evaluation is recommended when the score is 10 or greater. Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity. Patient Health Questionaire-9 (PHQ-9) 1-4 minimal depression, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe. EQ-5D-5L The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Baseline up to 9 months
Title
Change in pain assessment between telehealth group and usual care
Description
Edmonton Symptom Assessment Scale (ESAS) Scale 0 symptom is absent up to Scale 10 symptom is worst possible severity. Brief Pain Inventory (BPI) Scale 0 of no pain to scale 10 pain at its worse.
Time Frame
Baseline up to 9 months
Title
Change in satisfaction between telehealth group and usual care
Description
Telehealth patient satisfaction survey. Scale range: Poor - Fair - Good - Excellent
Time Frame
Baseline up to 9 months
Title
Incidence of adverse events
Time Frame
Up to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lakshmi Koyyalagunta
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lakshmi Koyyalagunta
Phone
713-745-4939
Email
dkoyyala@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Lakshmi Koyyalagunta

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center

Learn more about this trial

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

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