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 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.
Additional locations may be listed on ClinicalTrials.gov for NCT05077072.
See trial information on ClinicalTrials.gov for a list of participating sites.
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 cancer 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.
II. To examine the association between the symptom distress score as assessed by Edmonton Symptom Assessment Scale-Pain (ESAS) symptom distress score and NMOU status as assessed by Cut Down, Annoyed, Guilty, and Eye opener (CAGE) and/ or Screener and Opioid Assessment for Patients with Pain (SOAPP) scores.
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.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSriram Yennu
