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NCT Number: NCT05077072

Interdisciplinary Interventions to Address Pain Management Among 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practice

Other

Receive SOC

Other names: standard of care, standard therapy

Counseling

Other

Participate in CHAT counseling intervention

Other names: Counseling Intervention

electroencephalography

Procedure

Undergo EEG

Other names: EEG, electroencephalogram

Neurofeedback

Behavioral

Undergo NFB intervention

Other names: EEG biofeedback

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Oct 13, 2021
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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