Summary

This phase III trial compares the effect of adding an internet-based pain program (painTRAINER) to enhanced usual care versus enhanced usual care alone in improving pain severity and pain interference in cancer survivors. Adding painTRAINER to enhanced usual care with pain education may reduce pain and improve pain's impact on daily activities in cancer survivors compared to usual care plus pain education only.

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.

Eligibility

1. PATIENT INCLUSION CRITERIA
2. Must have a documented diagnosis of invasive cancer that has been treated with either single modality therapy or any combination of surgery, radiation, and chemotherapy/drug therapy (e.g. cytotoxic therapy, targeted therapy, immunotherapy, hormonal therapy, etc.). Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible.
3. May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer. * Patients who are currently undergoing anticancer therapy should not have any plans to change or adjust their treatment during the intervention period. This includes changing to another therapy or ending therapy entirely. * Patients who are currently receiving anticancer therapy at the screening process must have been on current therapy for at least four weeks. Alternatively, if they are planning to discontinue therapy before enrolling, they must have been off therapy for four weeks prior to enrollment. * A minimum of four weeks must have elapsed since the completion of the most recent course of radiation therapy. * A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention. * A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement). * In addition, eligible patients must not have a planned surgical procedure or course of radiation therapy during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint 2 [T2]).
4. Patients who are no longer receiving anticancer therapy must be =< 5 years since the completion of their anticancer therapy (e.g., time since the last day of chemotherapy administration, time since last day of radiotherapy, etc.).
5. Must have pain indicated by a score of >= 4 on Patient Reported Outcomes Measurement Information System (PROMIS) Pain Intensity (1a) scale, using the Pain Eligibility Interview within the Screening Interview.
6. Must have a score of “Most Days” or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview within the Screening Interview.
7. Patients do not have to be on analgesic medications of any kind in order to participate. If they are taking analgesics, they must be on a stable analgesic regimen (i.e., no changes to the prescribed analgesic regimen) over a period of at least 14 days prior to enrollment. Eligible patients should not have planned upward dose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint 2 [T2]). Patients may elect to decrease their analgesic use during the study as per discussions with their provider. Unexpected dose adjustments including dose escalations as a result of unforeseen clinical need is allowed in all patients at all times during the study. Cannabis prescribed for medicinal purposes would qualify as an analgesic in this context.
8. Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.
9. Must be expected to be able to complete all study activities including the 22- and 34-week follow-up assessments according to the treating/referring clinician (e.g., treating clinician feels the patient is unlikely to develop progressive disease requiring additional active cancer therapy through the 6-month follow-up period).
10. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
11. Age >= 18 years at the time of study entry
12. Must be able to speak, read and understand English.