RECRUITING

An Internet-based Program to Help Cancer Survivors Manage Pain

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Conditions

CancerCancer painSurvivorPainPain coping

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Internet-delivered Management of Pain Among Cancer Treatment Survivors

Quick Facts

Study Start:2021-05-13
Study Completion:2026-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04462302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * May be either off all treatment OR actively receiving anticancer therapy in an adjuvant setting, maintenance setting, or for active cancer.
  2. * 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.
  3. * 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.
  4. * A minimum of four weeks must have elapsed since the most recent MAJOR surgical intervention.
  5. * A minimum of two weeks must have elapsed since the most recent MINOR surgical procedure (e.g., port placement).
  6. * 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.
  7. * 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.).
  8. * Must have pain indicated by a score of ≥ 4 on PROMIS Pain Intensity (1a) scale, using the Pain Eligibility Interview.
  9. * Must have a score of "Most Days" or higher on the Graded Chronic Pain Scale Revised (Abbreviated) using the Pain Eligibility Interview.
  10. * 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.
  11. * Must have pain of new onset or significantly exacerbated since the time of cancer diagnosis or initiation of cancer treatment
  12. * 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).
  13. * ECOG performance status of 0, 1, or 2.
  14. * Age ≥18 years at the time of study entry
  15. * Must be able to speak, read and understand English.
  1. * 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.
  2. * Reports only preexisting pain conditions unrelated to cancer or cancer treatment (e.g., migraine or tension headache, arthritis, back disorders, bursitis/tendonitis, injuries, fibromyalgia).
  3. * 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.
  4. * Currently being prescribed buprenorphine or suboxone.
  5. * 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.
  6. * 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.
  7. * Does not have a working email address.

Contacts and Locations

Study Contact

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

Principal Investigator

Glenn Lesser, MD
STUDY_CHAIR
Wake Forest University Health Sciences

Study Locations (Sites)

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 - 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
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
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

Collaborators and Investigators

Sponsor: Wake Forest University Health Sciences

  • Glenn Lesser, MD, STUDY_CHAIR, Wake Forest University Health Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-05-13
Study Completion Date2026-08-31

Study Record Updates

Study Start Date2021-05-13
Study Completion Date2026-08-31

Terms related to this study

Keywords Provided by Researchers

  • Cancer pain
  • Survivor
  • Pain
  • Pain coping

Additional Relevant MeSH Terms

  • Cancer