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.
Full Title of Study: “Opioid-Sparing Interdisciplinary Interventions Addressing Pain in Head and Neck Cancer Patients”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Supportive Care
- Masking: Single (Investigator)
- Study Primary Completion Date: June 30, 2024
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.
- Other: Best Practice
- Receive SOC
- Other: Counseling
- Participate in CHAT counseling intervention
- Procedure: Electroencephalography
- Undergo EEG
- Behavioral: Neurofeedback
- Undergo NFB intervention
- Other: Questionnaire Administration
- Ancillary studies
Arms, Groups and Cohorts
- Experimental: ARM I (CHAT)
- Patients participate in CHAT counseling intervention over 45-60 minutes twice a month for up to 12 weeks.
- Experimental: ARM II (NFB)
- Patients undergo NFB intervention over 20-30 minutes twice a week for up to 10 weeks.
- Active Comparator: ARM III (SOC)
- Patients receive 2-3 standard of care sessions per month over 45-60 minutes for up to 12 weeks.
Clinical Trial Outcome Measures
- 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.
Participating in This Clinical Trial
- 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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- M.D. Anderson Cancer Center
- Provider of Information About this Clinical Study
- Overall Official(s)
- Sriram Yennu, Principal Investigator, M.D. Anderson Cancer Center
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