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

Head and Neck Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05077072
• Other study ID #: 2021-0337
• Secondary ID: NCI-2021-0942620
• Status: Recruiting
• Phase: Phase 2
• Start date: October 8, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: May 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Carcinoma
• Head and Neck Neoplasms

Intervention

Other:
• Best Practice
Receive SOC
• Counseling
Participate in CHAT counseling intervention

Procedure:
• Electroencephalography
Undergo EEG

Behavioral:
• Neurofeedback
Undergo NFB intervention

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   MD Anderson Cancer Center Website