An Internet-Based Program to Help Cancer Survivors Manage Pain, IMPACTS Study

Summary

Objectives

PRIMARY OBJECTIVE:
I. To determine whether painTRAINER plus enhanced usual care (henceforth known simply as painTRAINER), compared to enhanced usual care alone, yields significant improvements in the co-primary outcomes of pain severity (as measured by the Brief Pain Inventory [BPI]) and pain interference (also measured by the BPI) from baseline to the post-intervention assessment (timepoint 2, week 10) for cancer survivors with persistent pain.

SECONDARY OBJECTIVES:
I. To determine whether painTRAINER®, compared to enhanced usual care alone, yields significant
improvement in pain severity (measured by the BPI) from baseline to the post-intervention assessment (timepoint 2, week 10) for cancer survivors with persistent pain.
II. To determine whether painTRAINER®, compared to enhanced usual care alone, yields significant
improvements in pain severity and pain interference at the 3- and 6-month (T3 and T4) follow-up assessments.
III. To determine whether painTRAINER, compared to enhanced usual care alone, yields significant improvements in secondary outcomes of opioid/analgesic medication use, health-related quality of life (HRQoL), and pain management self-efficacy among cancer survivors with persistent pain.

EXPLORATORY OBJECTIVES:
I. To determine whether painTRAINER, compared to enhanced usual care alone, yields significant improvements in exploratory outcomes of fatigue, sleep, emotional distress, pain impact, perceived cognitive problems among cancer survivors with persistent pain.
II. To perform exploratory subgroup analyses evaluating painTRAINER versus (vs.) enhanced usual care on changes in pain severity, pain interference, and secondary and exploratory outcomes where subgroups are defined based on: baseline demographic characteristics, comorbidities, cancer type, treatment status, experience with technology, pain characterization (i.e., neuropathic vs. nociceptive), pain chronicity, pain catastrophizing, pain resilience, patient impression of change, substance use and opioid/analgesic use.
III. To explore associations between baseline and change in pain severity, pain interference, and secondary and exploratory outcomes and: patient covariates used to define the subgroups above as well as social determinants of health (e.g., race, gender, ethnicity, community poverty, housing quality, and access to care).
IV. To describe patient satisfaction and experience with painTRAINER and engagement and use with painTRAINER.
V. To identify potential barriers and facilitators for implementing painTRAINER as well as pain-management needs unique to racial and ethnic minority cancer survivors using semi-structured interviews.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients complete the painTRAINER internet-based pain program over 35-45 minutes for a total of 8 sessions within 10 weeks. Patients also receive enhanced usual care with pain education materials at baseline.

ARM II: Patients receive enhanced usual care with pain education materials at baseline.

After completion of study, patients are followed up at 3 and 6 months.