Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

November 15, 2023 updated by: M.D. Anderson Cancer Center

Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients

This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups.

SECONDARY OBJECTIVES:

I. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC.

II. Examine the pain severity (area under the curve [AUC]), daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD), and mood (Hospital Anxiety and Depression Scale, HADS) for each of the treatment arms (CHAT, NFB, or SOC) in head and neck cancer (HNC) patients receiving radiation therapy at the end of 3 months.

EXPLORATORY OBJECTIVE:

I. To examine the cortical and subcortical regions of the brain associated with pain and our interventions (CHAT, NFB, and SOC) and the extent to which changes in electroencephalogram (EEG) patterns mediate the effects of the intervention.

OUTLINE: Patients are randomized into 1 of 3 arms.

ARM I: Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.

ARM II: Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.

ARM III: Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Sriram Yennu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease
  • Willingness to be seen in the outpatient supportive care center (SCC)
  • History of use of non-medical opioid use (Screener and Opioid Assessment for Patients with Pain [SOAPP] >= 7+ and/or Cut Down, Annoyed, Guilty, and Eye opener questionnaire [CAGE] >= 2+)
  • Physician-estimated prognosis of at least 12 months
  • Age 18 or older
  • Able to complete study assessments
  • Willing to sign written informed consent
  • Both human papillomavirus (HPV) and non-HPV patients will be included
  • Patients currently receiving opioids for at least 1 week
  • Able to read, write and speak English

Exclusion Criteria:

  • Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of >= 13
  • Employees of MD Anderson Cancer Center

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ARM I (CHAT)
Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Counseling
Participate in CHAT counseling intervention
Other Names:
  • Counseling Intervention
Experimental: ARM II (NFB)
Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.
Other: Questionnaire Administration
Ancillary studies
Procedure: Electroencephalography
Undergo EEG
Other Names:
  • EEG
  • electroencephalogram
Behavioral: Neurofeedback
Undergo NFB intervention
Other Names:
  • EEG biofeedback
Active Comparator: ARM III (SOC)
Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.
Other: Questionnaire Administration
Ancillary studies
Other: Best Practice
Receive SOC
Other Names:
  • standard of care
  • standard therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of non-medical opioid use (NMOU) behaviors
Time Frame: through study completion, an average of a year.
Composite NMOU score is calculated by summing the number of times each behavior suggestive of NMOU is recorded.
through study completion, an average of a year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Sriram Yennu, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2021

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

June 30, 2024

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 30, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Estimated)

November 16, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-0337 (Other Identifier: M D Anderson Cancer Center)
  • NCI-2021-09426 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Head and Neck Carcinoma

Clinical Trials on Questionnaire Administration

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Korea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe