NCI ID NCI-2020-02315
NCT ID NCT04462302
CTEP ID WF-1901
Primary Purpose HEALTH_SERVICES_RESEARCH
Anatomic Sites Multiple
Minimum Age 18 Years
Maximum Age 999 Years
Gender BOTH
Lead Org Wake Forest NCORP Research Base
Principal Investigator Donald B. Penzien
NCI Site View on ClinicalTrials.gov

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

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.

Eligibility

Inclusion Criterea

  • PATIENT INCLUSION CRITERIA
  • 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.
  • May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer that is felt to be stable and/or controlled and not rapidly progressive as per treating clinician judgement at the time of screening. * Patients who are actively receiving anticancer therapy at the time of screening should not have plans in place to change to another therapy for the duration of the delivered intervention period (i.e., the three months leading up to primary outcome evaluation-timepoint 2 [T2]). * Patients who are actively receiving anticancer therapy at the time of screening must have been on that therapy for a minimum of four weeks prior to enrollment (i.e., no change in anticancer therapy in the previous month). * 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]).
  • 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.).
  • 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.
  • 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.
  • 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.
  • Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment.
  • 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).
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
  • Age >= 18 years at the time of study entry
  • Must be able to speak, read and understand English.

Exclusion Criterea

  • PATIENT EXCLUSION CRITERIA
  • Has a disability that precludes completion of study activities (e.g., severe vision or hearing impairment, diagnosis of dementia or clinical evidence of severe cognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder, or diagnosed drug or alcohol abuse disorder), as per patient report or documented in the medical record.
  • Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
  • Has a known or suspected diagnosable substance use disorder or opioid overuse disorder (according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition [DSM-5] criteria), or is actively receiving treatment for a substance use disorder, as per patient report or documented in the medical record.
  • Currently being prescribed buprenorphine or suboxone.
  • Patients enrolled on hospice care or end-of-life palliative care are not eligible for enrollment. Patients whose local care network provides an opportunity for palliative (symptom management) or supportive care concurrent with active treatment following diagnosis (i.e. not solely as a palliative or end-of-life measure) are considered eligible for this study.
  • Does not have reliable access to internet or sufficient personal data plan, and is not willing to participate in the Tablet Lending Program provided for this study.
  • Does not have a working email address.

Participating Clinics

OptumCare Cancer Care at Seven Hills


3175 Saint Rose Parkway
Suite 200 Henderson, NV 89052
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache


6190 South Fort Apache Road
Las Vegas, NV 89148
Map

702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley


3730 South Eastern Avenue
Las Vegas, NV 89169
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView


3150 North Tenaya Way
Suite 510 Las Vegas, NV 89128
Map

702-384-0013
research@sncrf.org

OptumCare Cancer Care at Charleston


2300 West Charleston Boulevard
Las Vegas, NV 89102
Map

702-384-0013