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Malignant Abdominal NeoplasmNCT04963972

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

A study testing Behavioral Intervention, Best Practice and Questionnaire Administration in people with Malignant Abdominal Neoplasm and Malignant Head and Neck Neoplasm, run by Lucid Lane, Inc at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Behavioral Intervention, Best Practice and Questionnaire Administration
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
1 siteUnited States
Study dates
23 Feb 2021to 1 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Lakshmi Koyyalagunta, 713-745-4939, dkoyyala@mdanderson.org

    Lakshmi Koyyalagunta

    Recruiting

Other trials in United States

About this study

Official title: Impact of Digital and Behavioral Tele-Health Tapering Program for Perioperative Surgical Patients Exposed to Opioids

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Behavioral Intervention, Best Practice, Questionnaire Administration
Medical subject headings
Head and Neck Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral InterventionBehavioural

    Also called Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy

    Participate in Lucid Lane therapy program

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive standard of care opioid education

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT04963972
Study groupRoleWhat they receive
Arm I (Lucid Lane)ExperimentalPatients 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.
Receives: Behavioral: Behavioral Intervention; Other: Questionnaire Administration
Arm II (standard of care)Active comparatorPatients receive standard of care post-surgical opioid education.
Receives: Other: Best Practice; Other: Questionnaire Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 90 days

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

    Measured: Up to 270 days

Secondary outcomes (5)

  1. 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.

    Measured: Baseline up to 9 months

  2. 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.

    Measured: Baseline up to 9 months

  3. 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.

    Measured: Baseline up to 9 months

  4. Change in satisfaction between telehealth group and usual care

    Telehealth patient satisfaction survey. Scale range: Poor - Fair - Good - Excellent

    Measured: Baseline up to 9 months

  5. Incidence of adverse events

    Measured: Up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2021
  2. Study start23 Feb 2021
  3. Primary completion1 Feb 2023 (estimated)
  4. Study completion1 Feb 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04963972
Sponsor's protocol ID
2020-0769
Other IDs
NCI-2021-00053
Status last verified
May 2022
First submitted
24 Feb 2021
Last updated
10 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Intervention, Best Practice and Questionnaire Administration in people with Malignant Abdominal Neoplasm and Malignant Head and Neck Neoplasm, run by Lucid Lane, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 10 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04963972.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2022.

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