An Internet-based Program to Help Cancer Survivors Manage Pain

Last updated: March 4, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Treatment

Internet-based pain coping skills program

Clinical Study ID

NCT04462302
IRB00066906
WF-1901
3UG1CA189824-06S1
NCI-2020-02315
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 anadjuvant setting, maintenance setting, or for active cancer.

  • Patients who currently undergoing anticancer therapy should not have any plansto change or adjust their treatment during the intervention period. Thisincludes changing to another therapy or ending therapy entirely.

  • Patients who are currently receiving anticancer therapy at the screeningprocess 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 surgicalintervention.

  • A minimum of two weeks must have elapsed since the most recent MINOR surgicalprocedure (e.g., port placement).

  • In addition, eligible patients must not have a planned surgical procedure orcourse 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 5years since the completion of their anticancer therapy (e.g., time since the lastday 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 toparticipate. If they are taking analgesics, they must be on a stable analgesicregimen (i.e., no changes to the prescribed analgesic regimen) over a period of atleast 14 days prior to enrollment. Eligible patients should not have planned upwarddose titration of their analgesics during the 3-month study intervention period (i.e., the three months leading up to primary outcome evaluation timepoint. Patientsmay elect to decrease their analgesic use during the study as per discussions withtheir provider. Unexpected dose adjustments including dose escalations as a resultof unforeseen clinical need is allowed in all patients at all times during thestudy. Cannabis prescribed for medicinal purposes would qualify as an analgesic inthis context.

  • Must have pain of new onset or significantly exacerbated since the time of cancerdiagnosis 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 diseaserequiring 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

Exclusion Criteria:

  • Has a disability that precludes completion of study activities (e.g., severe visionor hearing impairment, diagnosis of dementia or clinical evidence of severecognitive impairment, diagnosis or clinical evidence of severe psychiatric disorder,or diagnosed drug or alcohol abuse disorder), as per patient report or documented inthe 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 overusedisorder (according to DSM-5 criteria), or is actively receiving treatment for asubstance 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 eligiblefor enrollment. Patients whose local care network provides an opportunity forpalliative (symptom management) or supportive care concurrent with active treatmentfollowing diagnosis (i.e. not solely as a palliative or end-of-life measure) areconsidered eligible for this study.

  • Does not have reliable access to Internet or sufficient personal data plan, and isnot willing to participate in the Tablet Lending Program provided for this study.

  • Does not have a working email address.

Study Design

Total Participants: 456
Treatment Group(s): 1
Primary Treatment: Internet-based pain coping skills program
Phase:
Study Start date:
May 13, 2021
Estimated Completion Date:
April 01, 2026

Study 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).

Connect with a study center

  • FHP Health Center-Guam

    Tamuning, 96913
    Guam

    Active - Recruiting

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas 72903
    United States

    Active - Recruiting

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California 94531
    United States

    Active - Recruiting

  • Kaiser Permanente Dublin

    Dublin, California 94568
    United States

    Active - Recruiting

  • Kaiser Permanente-Fremont

    Fremont, California 94538
    United States

    Active - Recruiting

  • Kaiser Permanente-Fresno

    Fresno, California 93720
    United States

    Active - Recruiting

  • Kaiser Permanente-Modesto

    Modesto, California 95356
    United States

    Active - Recruiting

  • Kaiser Permanente-Oakland

    Oakland, California 94611
    United States

    Active - Recruiting

  • Kaiser Permanente- Marshall Medical Offices

    Redwood City, California 94063
    United States

    Active - Recruiting

  • Kaiser Permanente-Richmond

    Richmond, California 94801
    United States

    Active - Recruiting

  • Kaiser Permanente-Roseville

    Roseville, California 95661
    United States

    Active - Recruiting

  • Kaiser Permanente Downtown Commons

    Sacramento, California 95814
    United States

    Active - Recruiting

  • Kaiser Permanente-South Sacramento

    Sacramento, California 95823
    United States

    Active - Recruiting

  • Kaiser Permanente-San Francisco

    San Francisco, California 94115
    United States

    Active - Recruiting

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California 95119
    United States

    Active - Recruiting

  • Kaiser Permanente San Leandro

    San Leandro, California 94577
    United States

    Active - Recruiting

  • Kaiser San Rafael-Gallinas

    San Rafael, California 94903
    United States

    Active - Recruiting

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California 95051
    United States

    Active - Recruiting

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California 95403
    United States

    Active - Recruiting

  • Kaiser Permanente-South San Francisco

    South San Francisco, California 94080
    United States

    Active - Recruiting

  • Kaiser Permanente-Stockton

    Stockton, California 95210
    United States

    Active - Recruiting

  • Kaiser Permanente Medical Center-Vacaville

    Vacaville, California 95688
    United States

    Active - Recruiting

  • Kaiser Permanente-Vallejo

    Vallejo, California 94589
    United States

    Active - Recruiting

  • Kaiser Permanente-Franklin

    Denver, Colorado 80205
    United States

    Active - Recruiting

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado 80026
    United States

    Active - Recruiting

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia 31405
    United States

    Active - Recruiting

  • Hawaii Cancer Care - Savio

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Hawaii Cancer Care - Westridge

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Pali Momi Medical Center

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • The Cancer Center of Hawaii-Pali Momi

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • The Queen's Medical Center - West Oahu

    'Ewa Beach, Hawaii 96706
    United States

    Active - Recruiting

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii 96819
    United States

    Active - Recruiting

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Active - Recruiting

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Straub Clinic and Hospital

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

  • Tripler Army Medical Center

    Honolulu, Hawaii 96859
    United States

    Active - Recruiting

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

  • Carle BroMenn Outpatient Center

    Bloomington, Illinois 61704
    United States

    Active - Recruiting

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois 61704
    United States

    Active - Recruiting

  • Illinois CancerCare-Canton

    Canton, Illinois 61520
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Carle at The Riverfront

    Danville, Illinois 61832
    United States

    Active - Recruiting

  • Carle on Vermilion

    Danville, Illinois 61832
    United States

    Active - Recruiting

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Active - Recruiting

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois 61401
    United States

    Active - Recruiting

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois 61938
    United States

    Active - Recruiting

  • Carle BroMenn Medical Center

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • Carle Cancer Institute Normal

    Normal, Illinois 61761
    United States

    Active - Recruiting

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois 61350
    United States

    Active - Recruiting

  • Illinois CancerCare-Pekin

    Pekin, Illinois 61554
    United States

    Active - Recruiting

  • Illinois CancerCare-Peoria

    Peoria, Illinois 61615
    United States

    Active - Recruiting

  • Illinois CancerCare-Peru

    Peru, Illinois 61354
    United States

    Active - Recruiting

  • Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Active - Recruiting

  • Illinois CancerCare - Washington

    Washington, Illinois 61571
    United States

    Active - Recruiting

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa 52402
    United States

    Active - Recruiting

  • Broadlawns Medical Center

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa 50314
    United States

    Active - Recruiting

  • Flaget Memorial Hospital

    Bardstown, Kentucky 40004
    United States

    Active - Recruiting

  • Saint Joseph Hospital East

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky 40504
    United States

    Active - Recruiting

  • Saint Joseph London

    London, Kentucky 40741
    United States

    Active - Recruiting

  • Ochsner High Grove

    Baton Rouge, Louisiana 70836
    United States

    Site Not Available

  • Ochsner Medical Center Kenner

    Kenner, Louisiana 70065
    United States

    Site Not Available

  • Ochsner Baptist Medical Center

    New Orleans, Louisiana 70115
    United States

    Active - Recruiting

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana 70121
    United States

    Active - Recruiting

  • CHRISTUS Highland Medical Center

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan 48106
    United States

    Active - Recruiting

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan 48114
    United States

    Active - Recruiting

  • Trinity Health Medical Center - Canton

    Canton, Michigan 48118
    United States

    Active - Recruiting

  • Chelsea Hospital

    Chelsea, Michigan 48118
    United States

    Active - Recruiting

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan 48503
    United States

    Active - Recruiting

  • Genesee Hematology Oncology PC

    Flint, Michigan 48503
    United States

    Active - Recruiting

  • Genesys Hurley Cancer Institute

    Flint, Michigan 48503
    United States

    Active - Recruiting

  • Marshfield Medical Center Dickinson

    Iron Mountain, Michigan 49801
    United States

    Active - Recruiting

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan 48154
    United States

    Active - Recruiting

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan 48341
    United States

    Active - Recruiting

  • Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota 55422
    United States

    Active - Recruiting

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota 55416
    United States

    Active - Recruiting

  • Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

  • United Hospital

    Saint Paul, Minnesota 55102
    United States

    Active - Recruiting

  • Lakeview Hospital

    Stillwater, Minnesota 55082
    United States

    Active - Recruiting

  • Rice Memorial Hospital

    Willmar, Minnesota 56201
    United States

    Active - Recruiting

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri 65613
    United States

    Active - Recruiting

  • Heartland Regional Medical Center

    Saint Joseph, Missouri 64506
    United States

    Active - Recruiting

  • CentraState Medical Center

    Freehold, New Jersey 07728
    United States

    Active - Recruiting

  • Hackettstown Medical Center

    Hackettstown, New Jersey 07840
    United States

    Active - Recruiting

  • Morristown Medical Center

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Saint Peter's University Hospital

    New Brunswick, New Jersey 08901
    United States

    Active - Recruiting

  • Newton Medical Center

    Newton, New Jersey 07860
    United States

    Active - Recruiting

  • Chilton Medical Center

    Pompton, New Jersey 07444
    United States

    Active - Recruiting

  • Overlook Medical Center

    Summit, New Jersey 07901
    United States

    Active - Recruiting

  • Wake Forest University at Clemmons

    Clemmons, North Carolina 27012
    United States

    Active - Recruiting

  • Wake Forest University at Lexington

    Lexington, North Carolina 27292
    United States

    Active - Recruiting

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina 27157
    United States

    Active - Recruiting

  • The Mark H Zangmeister Center

    Columbus, Ohio 43219
    United States

    Active - Recruiting

  • Memorial Hospital

    Marysville, Ohio 43040
    United States

    Active - Recruiting

  • Knox Community Hospital

    Mount Vernon, Ohio 43050
    United States

    Active - Recruiting

  • Southern Ohio Medical Center

    Portsmouth, Ohio 45662
    United States

    Active - Recruiting

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania 18201
    United States

    Active - Recruiting

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania 17837
    United States

    Active - Recruiting

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania 17901
    United States

    Active - Recruiting

  • Community Medical Center

    Scranton, Pennsylvania 18510
    United States

    Active - Recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Active - Recruiting

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina 29910
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina 29316
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina 29640
    United States

    Active - Recruiting

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina 29440
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina 29615
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina 29605
    United States

    Active - Recruiting

  • Self Regional Healthcare

    Greenwood, South Carolina 29646
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina 29650
    United States

    Active - Recruiting

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina 29926
    United States

    Active - Recruiting

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina 29672
    United States

    Active - Recruiting

  • Peninsula Cancer Institute - Gloucester

    Gloucester, Virginia 23061
    United States

    Active - Recruiting

  • Peninsula Cancer Institute - Newport News

    Newport News, Virginia 23601
    United States

    Active - Recruiting

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia 23235
    United States

    Active - Recruiting

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

  • VCU Community Memorial Health Center

    South Hill, Virginia 23970
    United States

    Active - Recruiting

  • Peninsula Cancer Institute - Cancer Specialists of Tidewater

    Virginia Beach, Virginia 23235
    United States

    Active - Recruiting

  • Peninsula Cancer Institute - Williamsburg

    Williamsburg, Virginia 23185
    United States

    Active - Recruiting

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin 54729
    United States

    Active - Recruiting

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin 54701
    United States

    Active - Recruiting

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin 54848
    United States

    Active - Recruiting

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin 54449
    United States

    Active - Recruiting

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin 54548
    United States

    Active - Recruiting

  • Marshfield Medical Center - Neillsville

    Neillsville, Wisconsin 54456
    United States

    Active - Recruiting

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin 54868
    United States

    Active - Recruiting

  • Marshfield Medical Center-River Region at Stevens Point

    Stevens Point, Wisconsin 54482
    United States

    Active - Recruiting

  • Marshfield Clinic-Wausau Center

    Wausau, Wisconsin 54401
    United States

    Active - Recruiting

  • Marshfield Medical Center - Weston

    Weston, Wisconsin 54476
    United States

    Active - Recruiting

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin 54494
    United States

    Active - Recruiting

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