Computerized PAINRelieveIt Protocol for Cancer Pain Control in Hospice

Principal Investigators

Dates: 10/1/13 – 12/31/16

Co-Principal Investigators: Robert Molokie, Diana Wilkie, Jim Wang

Co-Investigators:  Diana Wilkie, Robert Molokie, Yingwei Yao, Jim Wang

Abstract: Responsive to HL-133, our long-term goal is to improve pain control in adults with sickle cell disease (SCD) by phenotypic characterization of their chronic pain experiences. Often the etiology of SCD pain is thought to be only episodic, driven by mechanisms of somatic or visceral tissue damage, but it has become increasingly clear that adults with SCD also experience chronic pain. The lack of sufficient normative data for quantitative sensory testing (QST) measures in adults of African descent, however, is a barrier that must be addressed simultaneously with fundamental work to characterize chronic SCD pain phenotypes across time. We propose to determine normative QST values in 100 healthy African Americans to provide comparative data for an 18- month longitudinal study with repeated measures across seasons among 180 adult outpatients with SCD pain. We will characterize sensitization via quantitative sensory testing (QST) measures at three sites (2 painful, 1 non-painful) in adults with SCD pain; 4 times all 6 months apart. All subjects will complete well-validated, state-of- the-science self-report tools to characterize the perceived pain and its impact on quality of life and contribute samples for genetic and epigenetic analyses. Measures include: (1) mechanical QST (von Frey filaments), (2) thermal QST (cool/warm sensations, heat/cold pain thresholds), (3) self-report pain (PROMIS, PAINReportIt); (4) self-report neuropathic pain (S-LANSS, NPSI); (5) self-report quality of life (ASCQ-ME); and (6) genetic and epigenetic data (polymorphisms in the monoamine neurotransmitter systems, microRNA, and a global epigenetic marker LINE-1). Specific aims are: Aim 1. Based on normative values from 100 African American healthy volunteers, to compare the prevalence of pain sensitization in the healthy volunteers and 180 adults with SCD using mechanical and thermal stimulation of sensory fibers (A? [mechanical, von Frey QST], A-delta [cold QST], C [heat QST]). Hypothesis (HO): A significantly higher proportion of the SCD sample will report allodynia/hyperalgesia than healthy volunteers. Aim 2. From the 180 adults with SCD, to discover the chronic pain phenotype groups represented by the variability in the type of sensitization (none, central, peripheral, mixed) and pain characteristics (POMIS, PAINReportIt, S-LANSS, NPSI) and determine differences in self-report pain by the pain phenotypes. HO: Pain phenotypes will differ significantly on self-report pain (e.g., intensity, sensory, affective, pattern scores). Aim 3. Determine the genetic and epigenetic markers, pain treatment, environmental factors (season, temperature, wind), and quality of life scores associated with each phenotype across time among 180 adults with SCD. HO: Pain phenotypes with central or mixed sensitization will be associated with epigenetic markers (increased LINE-1 methylation, circulating let-7 microRNAs) and gene polymorphisms at the monoamine neurotransmitter network, high opioid doses, cold-related factors, and poorer quality of life. Findings will guide studies of adults to discover pain therapies for different pain phenotypes that effectively control chronic SCD pain and improve quality of life.

Specific aims are to compare usual hospice care and PAINRelieveIt groups for effects on:

  1. Patient outcomes (analgesic adherence; worst pain intensity, satisfaction, and misconceptions) and lay caregiver outcome (pain misconceptions) in a diverse sample of 250 cancer patient-caregiver dyads receiving hospice care.
  2. Nurse outcomes (obtained appropriate analgesics for patient) in a sample of hospice nurses.

We hypothesize that at posttest, controlling for pretest data and compared to the usual care group, the PAINRelieveIt group will: a) report decreased scores for worst pain intensity and pain misconceptions; b) have increased analgesic adherence (primary outcome); and c) have a larger proportion who report satisfaction with pain intensity and whose nurses obtained appropriate analgesics for the patients’ pain. Findings will guide future system-level research to implement PAINRelieveIt in a multi-site, longitudinal trial that will test the effect of disseminating this technology on clinical decisions for managing pain and patient/caregiver pain outcomes in a national sample of hospices. This approach offers improved pain control for dying patients and other populations.

Patient-Centered Outcomes Research Institute