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Behavioral Intervention for Head and Neck Cancers

N/A

Recruiting

Led By Lakshmi Koyyalagunta

Research Sponsored by Lucid Lane, Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months

Awards & highlights

Study Summary

This trial is studying whether behavioral therapies can help people lower their dependence on opioids after surgery.

Eligible Conditions

Head and Neck Cancers
Abdominal Cancer
Lung Cancer
Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

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

Change in pain assessment between telehealth group and usual care

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

+2 more

Side effects data

From 2013 Phase 1 & 2 trial • 16 Patients • NCT01923896

13%

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Behavioral Intervention & DCS

Behavioral Intervention & Placebo

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (Lucid Lane)Experimental Treatment2 Interventions

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.

Group II: Arm II (standard of care)Active Control2 Interventions

Patients receive standard of care post-surgical opioid education.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Behavioral Intervention

2021

Completed Phase 4

~3740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Lucid Lane, IncLead Sponsor

1 Previous Clinical Trials

103 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,967 Previous Clinical Trials

1,804,530 Total Patients Enrolled

Lakshmi KoyyalaguntaPrincipal InvestigatorM.D. Anderson Cancer Center

1 Previous Clinical Trials

100 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research recruiting volunteers at this time?

"Affirmative, the information on clinicaltrials.gov states that this medical experiment is actively searching for volunteers. It was first published to the public on February 23rd 2021 and last adjusted on May 4th 2022. There are 272 participants needed from a single site."

Answered by AI

How many individuals are enrolled in this investigation?

"Confirmed, the information provided by clinicaltrials.gov reveals that this trial is currently searching for participants. The initial posting was on February 23rd 2021 and it has been updated as recently as May 4th 2022. 272 subjects from 1 site must be enrolled in order to complete the study's objectives."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "Digital and Behavioral Tele-Health Tapering Program for Lowering Dependence on Opioids in Patients Undergoing Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04963972.