Saturday, November 23, 2024
11/23/2024
PROJECT SUMMARY BACKGROUND: For patients with head and neck cancer receiving radiation therapy (HNC), the frequency of substantial pain may be as high as 60 to 90% due to both the disease and its treatment. In the face of the opioid crisis, there has been a universal push for opioid-sparing treatments in patients with pain; however, this is not a viable option for most HNC patients experiencing pain, as there remains a lack of alternative pain control modalities. Our preliminary data suggest that in HNC patients, there is a higher risk of non-medical opioid use (NMOU) and a higher frequency of positive CAGE (Cut Down, Annoyed, Guilty, and Eye opener) scores. The high NMOU risk exposes patients and their families to harm, but patients still need effective pain relief. There is, therefore, a critical need to find new and effective methods for management of pain in patients with HNC who have a high risk of NMOU. This proposal will focus on two promising interventions targeting different underlying mechanisms of NMOU. CHAT (Compassionate High Alert Team) is an intensive, manualized, interdisciplinary, and patient-centered approach to manage patients with a high risk of NMOU. Neurofeedback (NFB) has shown promise in controlling pain and concomitant psychosocial aspects of pain. However, to date there are no studies of NFB for NMOU risk behaviors in cancer patients receiving treatment. OBJECTIVES: The long-term objective of this work is to devise effective strategies to manage cancer patients with NMOU behaviors, but who must be prescribed an opioid to treat their pain. SPECIFIC AIMS: 1. To test the hypothesis that this study will be feasible, as defined by adequate rates of adherence in the CHAT and NFB groups. 2. To examine the frequency of NMOU behaviors at the end of 3 months after CHAT, NFB, and SOC. 3. We will examine the pain severity [area under the curve (AUC)] and daily opioid use [AUC of the cumulative morphine equivalent daily dose (MEDD)] for each of the treatment arms (CHAT, NFB, or SOC) in HNC patients at the end of 3 months. 4. 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 EEG patterns mediate the effects of the intervention. RESEARCH DESIGN: This will be a Phase 2 randomized controlled trial. Patients with HNC will be screened for evidence of NMOU risk and offered the opportunity to participate in the study if they screen positive. Patients will be randomized to either CHAT, NFB, or SOC. We will assess the feasibility, change in frequency of NMOU behaviors, change in pain severity [area under the curve (AUC)] and daily opioid use AUC of the cumulative morphine equivalent daily dose (MEDD) at the end of 3 months after CHAT, NFB, and SOC. Finally, the exploratory aim in this proposal will generate exciting new insight into the problem of pain, NMOU behavior, and mechanisms of CHAT and NFB. This study could identify two novel patient approaches to NMOU management, CHAT and NFB, with the potential to positively impact the lives of cancer patients across the U.S. and worldwide.
HHS’ Tracking Accountability in Government Grants System (TAGGS) website provides access to detailed descriptions of grants, loans, aggregated direct payments and other types of financial assistance awarded by the HHS Operating Divisions (OPDIVs) and the Office of the Secretary Staff Divisions (STAFFDIVs).
