RECRUITING

An Internet-based Program to Help Cancer Survivors Manage Pain

Description

To determine whether an Internet-based pain coping skills program plus enhanced usual care, 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 for cancer survivors with persistent pain.

Conditions

Study Overview

Study Details

Study overview

To determine whether an Internet-based pain coping skills program plus enhanced usual care, 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 for cancer survivors with persistent pain.

Internet-delivered Management of Pain Among Cancer Treatment Survivors

An Internet-based Program to Help Cancer Survivors Manage Pain

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Fort Smith

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States, 72903

Antioch

Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States, 94531

Dublin

Kaiser Permanente Dublin, Dublin, California, United States, 94568

Fremont

Kaiser Permanente-Fremont, Fremont, California, United States, 94538

Fresno

Kaiser Permanente-Fresno, Fresno, California, United States, 93720

Modesto

Kaiser Permanente-Modesto, Modesto, California, United States, 95356

Oakland

Kaiser Permanente-Oakland, Oakland, California, United States, 94611

Redwood City

Kaiser Permanente- Marshall Medical Offices, Redwood City, California, United States, 94063

Richmond

Kaiser Permanente-Richmond, Richmond, California, United States, 94801

Roseville

Kaiser Permanente-Roseville, Roseville, California, United States, 95661

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
  • * Patients who 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 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.
  • * Patients who are no longer receiving anticancer therapy must be less than/equal to 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 PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
  • * Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility 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. 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).
  • * 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.
  • * 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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Wake Forest University Health Sciences,

Glenn Lesser, MD, STUDY_CHAIR, Wake Forest University Health Sciences

Study Record Dates

2026-04-01