An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    456
  • sponsor
    Wake Forest University Health Sciences
Updated on 7 October 2022
treatment regimen
hormone therapy
cancer diagnosis
cancer treatment
primary cancer
targeted therapy
immunostimulants

Summary

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 456 participants will be enrolled (228 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).

Details
Condition Cancer
Treatment Internet-based pain coping skills program
Clinical Study IdentifierNCT04462302
SponsorWake Forest University Health Sciences
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

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
ECOG performance status of 0, 1, or 2
Age ≥18 years at the time of study entry
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
Must be able to speak, read and understand English
the delivered intervention period (i.e., the three month leading up to primary
outcome evaluation.)
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 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
-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)

Exclusion Criteria

Currently being prescribed buprenorphine or suboxone
Does not have a working email address
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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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