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

NCT05077072 | Active Not Recruiting Phase 2

• 2 other identifiers: 2021-0337NCI-2021-09426
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Head and Neck Carcinoma

Outcome Measures

Primary Outcomes (1)

• Frequency of non-medical opioid use (NMOU) behaviors

  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.

Study Arms (3)

ARM I (CHAT)

EXPERIMENTAL

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

Other: Counseling; Other: Questionnaire Administration

ARM II (NFB)

EXPERIMENTAL

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

Procedure: Electroencephalography; Behavioral: Neurofeedback; Other: Questionnaire Administration

ARM III (SOC)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Receive SOC

Also known as: standard of care, standard therapy

ARM III (SOC)

Counseling OTHER

Participate in CHAT counseling intervention

Also known as: Counseling Intervention

ARM I (CHAT)

Electroencephalography PROCEDURE

Undergo EEG

Also known as: EEG, electroencephalogram

ARM II (NFB)

Neurofeedback BEHAVIORAL

Undergo NFB intervention

Also known as: EEG biofeedback

ARM II (NFB)

Questionnaire Administration OTHER

Ancillary studies

ARM I (CHAT); ARM II (NFB); ARM III (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Interventions

Practice Guidelines as Topic; Standard of Care; Counseling; Neurofeedback

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Feedback, Psychological

Study Officials

• Sriram Yennu

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 13, 2021
• Study Start: October 8, 2021
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)