ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-10-08
Study Completion:2027-10-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05077072

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of HNC, with patient scheduled to receive radiation therapy, with or without evidence of active disease
  2. * Willingness to be seen in the outpatient supportive care center (SCC)
  3. * 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+)
  4. * Physician-estimated prognosis of at least 12 months
  5. * Age 18 or older
  6. * Able to complete study assessments
  7. * Willing to sign written informed consent
  8. * Both human papillomavirus (HPV) and non-HPV patients will be included
  9. * Patients currently receiving opioids for at least 1 week
  10. * Able to read, write and speak English
  1. * Individual with clinically evident impaired cognition by Memorial Delirium Assessment Scale (MDAS) score of \>= 13
  2. * Employees of MD Anderson Cancer Center

Contacts and Locations

Principal Investigator

Sriram Yennu
PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center

Study Locations (Sites)

M D Anderson Cancer Center
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

  • Sriram Yennu, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

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 Registration Dates

Study Start Date2021-10-08
Study Completion Date2027-10-31

Study Record Updates

Study Start Date2021-10-08
Study Completion Date2027-10-31

Terms related to this study

Additional Relevant MeSH Terms

  • Head and Neck Carcinoma