Funded Projects

NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

Chronic pain is common, costly, and debilitating. Opioid prescription in the treatment of chronic pain is frequent and carries a consequent risk of poor treatment outcome, as well as higher morbidity and mortality in a clinically significant number of patients, particularly those who meet criteria for opioid dependence. Despite the alarming increases in prescription opiate misuse and opioid use disorder (OUD) nationally in the United States, there are few treatment options available that target both pain-related interference and OUD among patients with chronic pain. In military veterans, this issue is of particular importance as numerous reports indicate frequent use of opioids in the treatment of chronic pain, as well as increasing opioid-related problems. To date, there are no evidence-based treatment options that aim to both reduce pain interference while simultaneously addressing problematic opioid use. The overall aim of this study will be to determine the efficacy of an integrated psychosocial treatment in veterans with chronic pain who are taking buprenorphine for the treatment of OUD. To achieve this aim, they will utilize a randomized design to assess the efficacy of two empirically supported interventions: Acceptance and Commitment Therapy for chronic pain and Mindfulness-Based Relapse Prevention for substance use and misuse.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Knee osteoarthritis is one of the leading causes of disability worldwide, particularly among older adults. Despite multiple guidelines for care, most patients do not receive adequate treatment, and about 30% are prescribed long-term opioids. This award will be used to recruit and support an early career faculty member from a group underrepresented in biomedicine. This research, part of the Pain Management Effectiveness Research Network will evaluate conservative and more aggressive treatments for knee osteoarthritis and determine which individual-level factors contribute to treatment outcomes.

NOFO Title: CTSA Network - Trial Innovation Centers (TICs) (U24)
NOFO Number: RFA-TR-15-002

NOFO Title: Clinical and Translational Science Award (CTSA) Network Recruitment Innovation Centers (RICs)(U24)
NOFO Number: RFA-TR-15-004

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

Social determinants of heath may affect breast cancer diagnosis and disease staging at time of mastectomy. It is unclear if socioeconomic factors such as annual income, marital status/single parent household, number of children, distance from the hospital, and other life stressors facing individuals from under-resourced populations affect development of postmastectomy pain syndrome or response to the drug ketamine. This research will analyze these factors toward mitigating post-mastectomy pain. This analysis will also serve as the basis for further research to define pathways that minimize health disparities plays in the development of chronic, post-surgical pain. The ultimate goal of this research is to normalize risk for chronic pain after breast surgery.

 

NOFO Title: HEAL Initiative: Sickle Cell Disease Pain Management Trials Utilizing the Pain Management Effectiveness Research Network Cooperative Agreement (UG3/UH3, Clinical Trial Required)
NOFO Number: RFA-AT-23-002
Summary:

Pain is the most common symptom of sickle cell disease (SCD), contributing to poor physical and emotional health outcomes and exacerbating socially determined health disparities at significant societal cost. PRESENCE will be the first study to compare the effectiveness of a cognitive behavioral therapy (CBT) program with and without peer support to usual care as a non-pharmaceutical option for pain management in adolescents and young adults living with SCD. CBT is delivered through an innovative digital app that is accessed on a mobile device with one group receiving self-guided CBT, a second group receiving CBT plus peer support, and a third group receiving usual SCD care. The PRESENCE program is comprised of strong community partnerships that provide the peer support component of the intervention. Measured outcomes will include pain and emotional health.

NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

The study team developed an mHealth pain self-management intervention for the perioperative period (SurgeryPal) to target psychosocial risk factors and teach pain self-management skills. The goal of this proposal is to establish the effectiveness of the SurgeryPal psychosocial intervention to improve clinically meaningful outcomes in adolescents undergoing major musculoskeletal surgery, and to identify the optimal timing of intervention delivery. The study team will plan for the efficient implementation of a multisite randomized clinical trial at 25 centers in 500 youth ages 12–18 years undergoing spinal fusion surgery and their parents. Participants will be randomized to receive SurgeryPal or attention control condition during the preoperative and postoperative phases. Self-reported pain severity and interference and secondary outcomes will be assessed at baseline, 3-, and 6-months. If effective, this scalable, low cost intervention will allow broad implementation to prevent chronic postsurgical pain in youth.

NOFO Title: HEAL Initiative: Pain Management Effectiveness Research Network: Clinical Trial Planning and Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required)
NOFO Number: RFA-NS-19-021
Summary:

Chronic musculoskeletal pain is common and often severe enough to be disabling. Some treatments such as cognitive behavioral therapies or analgesics may relieve pain for some, but not all patients. Combining effective therapies and providing support to ensure that patients are motivated to adhere to their treatment may prove to be more beneficial to patients than prescribing a drug or recommending a single non-pharmacological treatment. This study aims to evaluate a combination of complementary treatments and Registered Nurse (RN) support to motivate patients to use and maintain combined therapies. Some patients will receive phone-based motivational interviews with an RN to enhance their adherence to pain coping skills learned through web-based cognitive behavioral therapy in combination with duloxetine, a pain-relieving drug. Others will receive both treatments but will not receive support from an RN. The study aims to determine whether motivational nursing support enhances adherence to newly learned pain coping skills, and results in improved pain relief and physical function.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Cancer remains a leading cause of death among Hispanic/Latino populations in the United States. Compared with non-Hispanic Whites, Hispanic/Latino cancer patients are more likely to experience poor quality of life and inadequate cancer-related care, including less effective pain relief and poor patient‒provider communication. Additionally, Hispanic/Latino populations often have inadequate access to pain treatment, due to both social disparities and language barriers. However, most behavioral and psychosocial oncology research continues to focus on non-Hispanic Whites, and empirically validated and effective treatment interventions, particularly psychosocial interventions, are often not available in Spanish. This project will generate a Spanish-language version of the painTRAINER internet-based coping skills training program that is both linguistically and culturally sensitive and will evaluate its feasibility and acceptability in Hispanic/Latino patients with persistent cancer-related pain.

NOFO Title: NCI Community Oncology Research Program (NCORP) Research Bases (UG1 Clinical Trial Required)
NOFO Number: RFA-CA-18-015
Summary:

Pain Coping Skills Training (PCST) uses a cognitive behavioral therapy (CBT) approach to teach patients cognitive and behavioral coping skills shown to reduce pain and pain interference (e.g., relaxation, distraction, cognitive restructuring, activity pacing). Randomized controlled trials show that PCST and similar CBT-based interventions, when delivered in a traditional in-person format, can improve pain and functioning in people with cancer and other conditions. Yet these interventions are underused in clinical care due to barriers such as high resource costs, a shortage of therapists trained to deliver them, and travel requirements for patients. This trial aims to deliver evidence-based behavioral pain interventions such as PCST with methods capable of overcoming barriers currently limiting patient access. This will be investigated using a two-arm trial comparing pain relief with the following interventions: painTRAINER in clinic with eight web-based follow-up sessions; enhanced usual care.