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An Internet-based Program to Help Cancer Survivors Manage Pain

An Internet-based Program to Help Cancer Survivors Manage Pain

Recruiting
18 years and older
All
Phase N/A

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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.

Description

This is a parallel group randomized controlled, prospective study that examines the effect of an Internet-based pain coping skills program on pain severity and pain interference among adult cancer survivors experiencing persistent cancer-related pain. The study also explores the effects of an Internet-based pain coping skills program on opioid/analgesic medication use, health-related quality of life, pain management self-efficacy and various other factors relevant among populations with persistent pain (i.e., fatigue, sleep, emotional distress, positive affect, pain impact, perceived cognitive problems, and cognitive performance), as well as qualitative assessments of participants experiences with pain and the intervention. A total of 250 participants will be enrolled (125 per arm) and randomized into the internet program arm (plus enhanced usual care) or Enhanced Usual Care alone.

Each participant will be enrolled in the study for 9 months (from randomization at week 0 to the final follow-up assessment at week 34).

Eligibility

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.
               -  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.
        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 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.

Study details
    Cancer

NCT04462302

Wake Forest University Health Sciences

16 February 2024

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