R01NR020031

Opioid Therapy for Pain in Individuals with Metastatic Cancer: Benefits, Harms, and Stakeholder Perspectives - Project Summary

Opioid therapy for pain in patients with metastatic cancer is a critical yet understudied area. Pain is experienced at some point by most patients with metastatic cancer. Prescribed opioids are a cornerstone of treating pain; the prevalent belief in the field has been that the benefits of palliating pain in metastatic cancer with opioids nearly always outweigh any potential harms.

This approach to opioid-related decisions in patients with metastatic cancer implies that patients' prognoses are either so short that these harms are not meaningful, or that benefits of opioids are substantial while harms are relatively minimal. Research on the benefits and harms of opioid therapy has exploded in the past decade but primarily focuses on individuals with chronic "non-cancer" pain. However, patients with cancer have been routinely excluded from these studies and resulting recommendations that favor more conservative opioid prescribing.

The few studies of patients with cancer generally support that serious harms occur but have significant methodologic limitations. Additionally, there are unique considerations in individuals with metastatic cancer, including life-limiting disease that may last years, high pain rates, and opioids as an accepted standard of care. Therefore, assessing benefits and risk factors for opioid-related harms in individuals with metastatic cancer is a critical gap in the literature and key to opioid-related decision-making.

The long-term goal of this program of research is to develop interventions that inform opioid-related decision-making for patients with metastatic cancer. We will use the behavioral decision research framework to create a comprehensive evidence base on which these interventions can be grounded, which is the objective of the present application.

To accomplish our aims, we have partnered with the NINR-funded Palliative Care Research Cooperative to develop a prospective cohort of patients newly diagnosed with metastatic cancer. We propose the following aims in patients with metastatic cancer:

Aim 1: Investigate the relationship between opioid therapy and opioid-related benefits.
Hypothesis 1: Opioid therapy will be associated with decreased pain severity and pain interference (co-primary outcomes).

Aim 2: Investigate risk factors for opioid-related harms.
Hypothesis 2a: Certain co-prescribed medications will be associated with increased risk of opioid side effects (e.g., benzodiazepines and somnolence).
Hypothesis 2b: Younger age, history of substance use disorder, and history of mood disorders will be associated with greater risk of opioid misuse and use disorder.
Approach: We will use linear mixed effects models (2a) and time-to-event analyses (2b).

Aim 3: Understand stakeholder (patient, family caregiver, clinician) perspectives on opioid-related decision-making.

Completion of these aims will lead directly to an R-series proposal to develop and test a novel intervention to inform opioid decision-making, followed by R-series proposals to study intervention effectiveness and implementation. This work has the potential to transform opioid prescribing and pain management for patients with metastatic cancer.

University Of Pittsburgh - Of The Commonwealth System Of Higher Education

NURSES UNDERSTAND THAT IMPROVING HEALTH AND WELL-BEING MEANS ADDRESSING PEOPLE'S NEEDS IN MULTIPLE SETTINGS, CONTEXTS, AND OVER THE WHOLE LIFE COURSE. SCIENCE SUPPORTED BY THE NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) USES THIS HOLISTIC PERSPECTIVE TO IMPROVE INDIVIDUAL AND POPULATION HEALTH AND ADVANCE HEALTH EQUITY. NINR-SUPPORTED RESEARCH PROMOTES HEALTH AND WELL-BEING BY ADDRESSING NEEDS AT MULTIPLE LEVELS INDIVIDUAL, FAMILY, COMMUNITY, AND SOCIETAL LEVELS AND DEVELOPING TREATMENT AND PREVENTION STRATEGIES THAT ARE RESPONSIVE TO THE REALITY OF PEOPLE'S LIVES. NURSES KNOW PEOPLE, AND PEOPLE TRUST NURSES. PATIENT AND FAMILIES INTERACT WITH NURSES MORE THAN ANY OTHER CLINICIANS. NURSING SCIENCE USES THIS SPECIAL RELATIONSHIP TO BETTER UNDERSTAND PATIENTS, FAMILIES, AND COMMUNITIES AND THE MANY FACTORS THAT INFLUENCE THEIR HEALTH. NURSING SCIENCE SUPPORTED BY NINR USES THIS KNOWLEDGE TO DEVELOP STRATEGIES FOR IMPROVING HEALTH AND WELLNESS ACROSS POPULATIONS, HEALTH CARE SETTINGS, AND THE LIFESPAN, WITH AN EMPHASIS ON ACHIEVING HEALTH EQUITY. NINR-SUPPORTED SCIENTISTS HAVE DEVELOPED INTERVENTIONS FOR: SUPPORTING PARENTS OF PREMATURE INFANTS, PROMOTING HIV PREVENTION IN UNDERSERVED POPULATIONS, IMPROVING TRANSITIONAL CARE LEADING TO BETTER OUTCOMES AND COST-SAVINGS, AND HELPING INNER-CITY CHILDREN MANAGE ASTHMA. NURSING SCIENCE TRANSCENDS THE BOUNDARIES OF DISEASE AND RESEARCH DISCIPLINES TO BETTER UNDERSTAND THE EXPERIENCES OF INDIVIDUALS AND FAMILIES LIVING WITH ILLNESS AND TO DEVELOP PERSONALIZED APPROACHES THAT MAXIMIZE HEALTH AND WELL-BEING FOR INDIVIDUALS AT ALL STAGES OF LIFE, ACROSS DIVERSE POPULATIONS AND SETTINGS. NINR-SUPPORTED SCIENCE USES NURSING SCIENCE'S UNIQUE, PATIENT AND COMMUNITY-FOCUSED PERSPECTIVE AND WIDE REACH ACROSS CLINICAL AND COMMUNITY SETTINGS TO ADVANCE OUR UNDERSTANDING OF THE SOCIAL DETERMINANTS OF HEALTH: THOSE FACTORS THAT ARE AT THE ROOT OF THE INEQUITIES THAT WE SEE, SUCH AS FOOD INSECURITY AND ACCESS TO HEALTHCARE. NINR RESEARCH EFFORTS IN WELLNESS INVESTIGATE THE KEY BIOLOGICAL, BEHAVIORAL, AND SOCIAL FACTORS THAT PROMOTE LONG-TERM HEALTH AND HEALTHY BEHAVIORS AND PREVENT THE DEVELOPMENT OF ILLNESS ACROSS HEALTH CONDITIONS, SETTINGS, AND THE LIFESPAN. RESEARCH IN WELLNESS IS ALSO FOCUSED ON DEVELOPING AND TESTING CULTURALLY APPROPRIATE INTERVENTIONS TO PROMOTE HEALTH AND PREVENT ILLNESS IN MINORITY AND UNDERSERVED GROUPS. NINR ALSO SUPPORTS SCIENCE TO ASSIST INDIVIDUALS, FAMILIES, AND HEALTH CARE PROFESSIONALS IN MANAGING ADVANCED, SERIOUS ILLNESS, AND PLANNING FOR END-OF-LIFE DECISIONS. IN ADDITION, NINR PROMOTES TECHNOLOGICAL ADVANCEMENTS THAT ADDRESS A RANGE OF HEALTH CARE CHALLENGES AND FACILITATE THE DELIVERY OF REAL-TIME PERSONALIZED INFORMATION TO INDIVIDUALS AND FAMILIES, HEALTH CARE PROVIDERS, AND COMMUNITIES. FINALLY, NINR HAS A LONGSTANDING AND CONTINUING COMMITMENT TO DEVELOPING THE NEXT GENERATION OF NURSE SCIENTISTS: THOSE INDIVIDUALS AND TEAM MEMBERS WHO WILL CARRY THE FIELD OF NURSING SCIENCE INTO THE FUTURE. IN ORDER TO PREPARE AN INNOVATIVE, DIVERSE, AND TALENTED NEXT GENERATION OF NURSE SCIENTISTS, NINR SUPPORTS A VARIETY OF TRAINING OPPORTUNITIES FOR SCIENTISTS AND TRAINEES AT ALL CAREER LEVELS, PARTICULARLY THOSE AT AN EARLY CAREER STAGE WHO ARE SO CRITICAL TO SUSTAINING THE FUTURE OF INNOVATIVE RESEARCH AND HIGH QUALITY HEALTH CARE.

93.361 - Nursing Research

National Institute of Nursing Research (NINR) [HHS - NIH]

Pittsburgh, Pennsylvania 152133203 United States

Single Zip Code

End-of-Life and Palliative Care Approaches to Advanced Signs and Symptoms (R01 Clinical Trial Optional) (PAR-19-045)

Amendment Since initial award the total obligations have increased 372% from $739,175 to $3,491,253.