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NCT04462302NARecruiting

An Internet-based Program to Help Cancer Survivors Manage Pain

Wake Forest University Health Sciences

Start Date

5/13/2021

Completion Date

5/31/2028

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.

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 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 Criteria

Age Range: 18 years to No maximum

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.

Interventions

BEHAVIORAL

Internet-based pain coping skills program

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Conditions

Cancer

Locations

Mercy Hospital Fort Smith

Fort Smith, Arkansas 72903

United States

Kaiser Permanente-Deer Valley Medical Center

Antioch, California 94531

United States

Kaiser Permanente Dublin

Dublin, California 94568

United States

Kaiser Permanente-Fremont

Fremont, California 94538

United States

Kaiser Permanente-Fresno

Fresno, California 93720

United States

Kaiser Permanente-Modesto

Modesto, California 95356

United States

Kaiser Permanente-Oakland

Oakland, California 94611

United States

Kaiser Permanente- Marshall Medical Offices

Redwood City, California 94063

United States

Kaiser Permanente-Richmond

Richmond, California 94801

United States

Kaiser Permanente-Roseville

Roseville, California 95661

United States

Kaiser Permanente Downtown Commons

Sacramento, California 95814

United States

Kaiser Permanente-South Sacramento

Sacramento, California 95823

United States

Kaiser Permanente-San Francisco

San Francisco, California 94115

United States

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California 95119

United States

Kaiser Permanente San Leandro

San Leandro, California 94577

United States

Kaiser San Rafael-Gallinas

San Rafael, California 94903

United States

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California 95051

United States

Kaiser Permanente-Santa Rosa

Santa Rosa, California 95403

United States

Kaiser Permanente-South San Francisco

South San Francisco, California 94080

United States

Kaiser Permanente-Stockton

Stockton, California 95210

United States

Kaiser Permanente Medical Center-Vacaville

Vacaville, California 95688

United States

Kaiser Permanente-Vallejo

Vallejo, California 94589

United States

Kaiser Permanente-Franklin

Denver, Colorado 80205

United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado 80026

United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado 80124

United States

John B. Amos Cancer Center

Columbus, Georgia 31904

United States

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

Savannah, Georgia 31405

United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii 96813

United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii 96813

United States

Queen's Medical Center

Honolulu, Hawaii 96813

United States

Straub Clinic and Hospital

Honolulu, Hawaii 96813

United States

University of Hawaii Cancer Center

Honolulu, Hawaii 96813

United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii 96817

United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii 96817

United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii 96819

United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii 96826

United States

Tripler Army Medical Center

Honolulu, Hawaii 96859

United States

Hawaii Cancer Care - Savio

‘Aiea, Hawaii 96701

United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii 96701

United States

Pali Momi Medical Center

‘Aiea, Hawaii 96701

United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii 96701

United States

The Queen's Medical Center - West Oahu

‘Ewa Beach, Hawaii 96706

United States

Carle BroMenn Outpatient Center

Bloomington, Illinois 61704

United States

Illinois CancerCare-Bloomington

Bloomington, Illinois 61704

United States

Illinois CancerCare-Canton

Canton, Illinois 61520

United States

Northwestern University

Chicago, Illinois 60611

United States

Carle at The Riverfront

Danville, Illinois 61832

United States

Carle on Vermilion

Danville, Illinois 61832

United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois 62526

United States

Decatur Memorial Hospital

Decatur, Illinois 62526

United States

Illinois CancerCare-Galesburg

Galesburg, Illinois 61401

United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois 61938

United States

Carle BroMenn Medical Center

Normal, Illinois 61761

United States

Carle Cancer Institute Normal

Normal, Illinois 61761

United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois 61350

United States

Illinois CancerCare-Pekin

Pekin, Illinois 61554

United States

Illinois CancerCare-Peoria

Peoria, Illinois 61615

United States

Illinois CancerCare-Peru

Peru, Illinois 61354

United States

Carle Cancer Center

Urbana, Illinois 61801

United States

Illinois CancerCare - Washington

Washington, Illinois 61571

United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa 50023

United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa 52402

United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa 50325

United States

Medical Oncology and Hematology Associates-Des Moines

Des Moines, Iowa 50309

United States

Broadlawns Medical Center

Des Moines, Iowa 50314

United States

Mercy Medical Center - Des Moines

Des Moines, Iowa 50314

United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa 50314

United States

UI Health Care Mission Cancer and Blood - Waukee Clinic

Waukee, Iowa 50263

United States

Flaget Memorial Hospital

Bardstown, Kentucky 40004

United States

Saint Joseph Radiation Oncology Resource Center

Lexington, Kentucky 40504

United States

Saint Joseph Hospital East

Lexington, Kentucky 40509

United States

Saint Joseph London

London, Kentucky 40741

United States

Ochsner Baptist Medical Center

New Orleans, Louisiana 70115

United States

Ochsner Medical Center Jefferson

New Orleans, Louisiana 70121

United States

CHRISTUS Highland Medical Center

Shreveport, Louisiana 71105

United States

MaineHealth Cancer Care Center of York County

Sanford, Maine 04073

United States

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan 48106

United States

Trinity Health Medical Center - Brighton

Brighton, Michigan 48114

United States

Trinity Health Medical Center - Canton

Canton, Michigan 48118

United States

Chelsea Hospital

Chelsea, Michigan 48118

United States

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan 48503

United States

Genesee Hematology Oncology PC

Flint, Michigan 48503

United States

Genesys Hurley Cancer Institute

Flint, Michigan 48503

United States

Marshfield Medical Center Dickinson

Iron Mountain, Michigan 49801

United States

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan 48154

United States

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan 48341

United States

Mercy Hospital

Coon Rapids, Minnesota 55433

United States

Fairview Southdale Hospital

Edina, Minnesota 55435

United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota 55109

United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota 55407

United States

North Memorial Medical Health Center

Robbinsdale, Minnesota 55422

United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota 55416

United States

Regions Hospital

Saint Paul, Minnesota 55101

United States

United Hospital

Saint Paul, Minnesota 55102

United States

Lakeview Hospital

Stillwater, Minnesota 55082

United States

Rice Memorial Hospital

Willmar, Minnesota 56201

United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota 55125

United States

Central Care Cancer Center - Bolivar

Bolivar, Missouri 65613

United States

Heartland Regional Medical Center

Saint Joseph, Missouri 64506

United States

CentraState Medical Center

Freehold, New Jersey 07728

United States

Hackettstown Medical Center

Hackettstown, New Jersey 07840

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Saint Peter's University Hospital

New Brunswick, New Jersey 08901

United States

Newton Medical Center

Newton, New Jersey 07860

United States

Chilton Medical Center

Pompton, New Jersey 07444

United States

Overlook Medical Center

Summit, New Jersey 07901

United States

Wake Forest University at Clemmons

Clemmons, North Carolina 27012

United States

Wake Forest University at Lexington

Lexington, North Carolina 27292

United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina 27157

United States

The Mark H Zangmeister Center

Columbus, Ohio 43219

United States

Memorial Hospital

Marysville, Ohio 43040

United States

Knox Community Hospital

Mount Vernon, Ohio 43050

United States

Southern Ohio Medical Center

Portsmouth, Ohio 45662

United States

Geisinger Medical Center

Danville, Pennsylvania 17822

United States

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania 18201

United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania 17837

United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania 17901

United States

Community Medical Center

Scranton, Pennsylvania 18510

United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania 18711

United States

Saint Joseph's/Candler - Bluffton Campus

Bluffton, South Carolina 29910

United States

Prisma Health Cancer Institute - Spartanburg

Boiling Springs, South Carolina 29316

United States

Medical University of South Carolina

Charleston, South Carolina 29425

United States

Prisma Health Cancer Institute - Easley

Easley, South Carolina 29640

United States

Tidelands Georgetown Memorial Hospital

Georgetown, South Carolina 29440

United States

Prisma Health Cancer Institute - Butternut

Greenville, South Carolina 29605

United States

Prisma Health Cancer Institute - Faris

Greenville, South Carolina 29605

United States

Prisma Health Cancer Institute - Eastside

Greenville, South Carolina 29615

United States

Self Regional Healthcare

Greenwood, South Carolina 29646

United States

Prisma Health Cancer Institute - Greer

Greer, South Carolina 29650

United States

South Carolina Cancer Specialists PC

Hilton Head Island, South Carolina 29926

United States

Prisma Health Cancer Institute - Seneca

Seneca, South Carolina 29672

United States

Peninsula Cancer Institute - Gloucester

Gloucester, Virginia 23061

United States

Peninsula Cancer Institute - Newport News

Newport News, Virginia 23601

United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia 23235

United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia 23298

United States

VCU Community Memorial Health Center

South Hill, Virginia 23970

United States

Peninsula Cancer Institute - Cancer Specialists of Tidewater

Virginia Beach, Virginia 23235

United States

Peninsula Cancer Institute - Williamsburg

Williamsburg, Virginia 23185

United States

Marshfield Clinic-Chippewa Center

Chippewa Falls, Wisconsin 54729

United States

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin 54701

United States

Marshfield Medical Center - Ladysmith

Ladysmith, Wisconsin 54848

United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin 54449

United States

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin 54548

United States

Marshfield Medical Center - Neillsville

Neillsville, Wisconsin 54456

United States

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin 54868

United States

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin 54482

United States

Marshfield Clinic-Wausau Center

Wausau, Wisconsin 54401

United States

Marshfield Medical Center - Weston

Weston, Wisconsin 54476

United States

Marshfield Clinic - Wisconsin Rapids Center

Wisconsin Rapids, Wisconsin 54494

United States

FHP Health Center-Guam

Tamuning, GU 96913

Guam