Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Must have a history of a cancer diagnosis and treatment. Must have a documented diagnosis of invasive cancer requiring therapy with any combination of surgery, radiation, and chemotherapy/drug therapy including single modality therapy only. Patients with a cancer history of only superficial skin cancers or in situ malignancy are not eligible. - Must have been ≥3 months, but not more than 24 months since the completion of definitive cancer therapy (i.e., time since the last day of chemotherapy administration) with either no evidence of residual disease or with stable disease, as established by imaging, clinical exam, or laboratory testing at the time of screening. - Must have completed all planned anticancer therapy with the exception of maintenance therapy when appropriate. Maintenance therapy includes planned chronic immunotherapy, hormonal therapy, targeted therapy or chemotherapy given to prevent recurrence of disease rather than to treat active disease (e.g. long-term PD-1 or PD-L1 inhibitors in NSCLC patients following initial chemotherapy). Time frame applies to the most recent completion of treatment if participant has experienced cancer recurrence(s). - 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 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 study period up to the 10 Week Follow-up Visit. 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. - Suspected or proven progressive cancer by clinical history, exam or imaging evaluation. [Must have stable disease or considered to have no evidence of disease (NED)]. - 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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model 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.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Internet-based program + Pain Education
If you are in this group, in additional to your usual care, you will be provided access to the 8-session Internet-based pain program plus pain education. You will need to complete your sessions within 10 weeks of being provided your log-in code. You will be allowed to revisit sessions that you have completed during this 10 weeks. After completion of the study, you will still be provided access to the 8-session Internet-based pain program.
  • Behavioral: Internet-based pain coping skills program
    The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.
No Intervention
Pain Education Only
If you are in this group, in addition to your usual care, you will be provided pain education at your initial clinic visit. After you have completed the 6-month follow up assessment, you will be provided a secure log-in code and invited to complete the 8 sessions of this Internet-based pain program on your own.

Recruiting Locations

Tidelands Georgetown Memorial Hospital
Georgetown, South Carolina 29440
Contact:
Site Public Contact
843-545-5600
broe@tidelandshealth.org

More Details

Status
Recruiting
Sponsor
Wake Forest University Health Sciences

Study Contact

Karen Craver
336-716-0891
NCORP@wakehealth.edu

Detailed 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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.