- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04462302
An Internet-based Program to Help Cancer Survivors Manage Pain (IMPACTS)
Internet-delivered Management of Pain Among Cancer Treatment Survivors
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Karen Craver
- Phone Number: 336-716-0891
- Email: NCORP@wakehealth.edu
Study Locations
-
-
Arkansas
-
Fort Smith, Arkansas, United States, 72903
- Recruiting
- Mercy Hospital Fort Smith
-
Contact:
- Phone Number: 800-378-9373
-
Principal Investigator:
- Jay W Carlson
-
-
California
-
Antioch, California, United States, 94531
- Recruiting
- Kaiser Permanente-Deer Valley Medical Center
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Dublin, California, United States, 94568
- Recruiting
- Kaiser Permanente Dublin
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
-
Fremont, California, United States, 94538
- Recruiting
- Kaiser Permanente-Fremont
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Fresno, California, United States, 93720
- Recruiting
- Kaiser Permanente-Fresno
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Modesto, California, United States, 95356
- Recruiting
- Kaiser Permanente-Modesto
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Oakland, California, United States, 94611
- Recruiting
- Kaiser Permanente-Oakland
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Redwood City, California, United States, 94063
- Recruiting
- Kaiser Permanente- Marshall Medical Offices
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
-
Richmond, California, United States, 94801
- Recruiting
- Kaiser Permanente-Richmond
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Roseville, California, United States, 95661
- Recruiting
- Kaiser Permanente-Roseville
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Sacramento, California, United States, 95814
- Recruiting
- Kaiser Permanente Downtown Commons
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Sacramento, California, United States, 95823
- Recruiting
- Kaiser Permanente-South Sacramento
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
San Francisco, California, United States, 94115
- Recruiting
- Kaiser Permanente-San Francisco
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
San Jose, California, United States, 95119
- Recruiting
- Kaiser Permanente-Santa Teresa-San Jose
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Naalya Greyz-Yusupov
-
San Leandro, California, United States, 94577
- Recruiting
- Kaiser Permanente San Leandro
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
San Rafael, California, United States, 94903
- Recruiting
- Kaiser San Rafael-Gallinas
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Santa Clara, California, United States, 95051
- Recruiting
- Kaiser Permanente Medical Center - Santa Clara
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Santa Rosa, California, United States, 95403
- Recruiting
- Kaiser Permanente-Santa Rosa
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
South San Francisco, California, United States, 94080
- Recruiting
- Kaiser Permanente-South San Francisco
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Principal Investigator:
- Natalya Greys-Yusupov
-
Stockton, California, United States, 95210
- Recruiting
- Kaiser Permanente-Stockton
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Vacaville, California, United States, 95688
- Recruiting
- Kaiser Permanente Medical Center-Vacaville
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
Vallejo, California, United States, 94589
- Recruiting
- Kaiser Permanente-Vallejo
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 877-642-4691
- Email: Kpoct@kp.org
-
-
Colorado
-
Denver, Colorado, United States, 80205
- Recruiting
- Kaiser Permanente-Franklin
-
Contact:
- Site Public Contact
- Phone Number: 303-720-2685
- Email: kristi.m.bronkan@kp.org
-
Principal Investigator:
- Alexander Menter
-
Lafayette, Colorado, United States, 80026
- Recruiting
- Kaiser Permanente-Rock Creek
-
Contact:
- Site Public Contact
- Phone Number: 303-720-2685
- Email: kristi.m.bronkan@kp.org
-
Principal Investigator:
- Alexander Menter
-
Lone Tree, Colorado, United States, 80124
- Recruiting
- Kaiser Permanente-Lone Tree
-
Contact:
- Site Public Contact
- Phone Number: 303-720-2685
- Email: kristi.m.bronkan@kp.org
-
Principal Investigator:
- Alexander Menter
-
-
Georgia
-
Savannah, Georgia, United States, 31405
- Recruiting
- Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
-
Contact:
- Email: underberga@sjchs.org
-
Contact:
- Phone Number: (912) 819-5704
-
Principal Investigator:
- Mark A Taylor
-
-
Hawaii
-
'Aiea, Hawaii, United States, 96701
- Recruiting
- Hawaii Cancer Care - Savio
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-539-2273
-
'Aiea, Hawaii, United States, 96701
- Recruiting
- Pali Momi Medical Center
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-486-6000
-
'Aiea, Hawaii, United States, 96701
- Recruiting
- Hawaii Cancer Care - Westridge
-
Contact:
- Phone Number: 808-539-2273
- Email: info@hawaiicancercare.com
-
Principal Investigator:
- Christa Braun-Inglis
-
Honolulu, Hawaii, United States, 96826
- Recruiting
- Kapiolani Medical Center for Women and Children
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-983-6090
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Hawaii Cancer Care Inc - Waterfront Plaza
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-524-6115
- Email: i.webster@hawaiicancercare.com
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Queen's Cancer Cenrer - POB I
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-532-0315
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Queen's Medical Center
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-545-8548
-
Honolulu, Hawaii, United States, 96813
- Recruiting
- Straub Clinic and Hospital
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-522-4333
-
Honolulu, Hawaii, United States, 96817
- Recruiting
- Queen's Cancer Center - Kuakini
-
Principal Investigator:
- Christa Braun-Inglis
-
Contact:
- Site Public Contact
- Phone Number: 808-531-8521
-
Honolulu, Hawaii, United States, 96819
- Recruiting
- Kaiser Permanente Moanalua Medical Center
-
Principal Investigator:
- Natalya Greyz-Yusupov
-
Contact:
- Phone Number: 808-432-5195
- Email: shelley.a.clark@kp.org
-
-
Illinois
-
Bloomington, Illinois, United States, 61704
- Recruiting
- Illinois CancerCare-Bloomington
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Bloomington, Illinois, United States, 61704
- Recruiting
- Carle BroMenn Outpatient Center
-
Contact:
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Suparna Mantha
-
Canton, Illinois, United States, 61520
- Recruiting
- Illinois CancerCare-Canton
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University
-
Principal Investigator:
- Christine Rini
-
Contact:
- Site Public Contact
- Phone Number: 312-695-1301
- Email: cancer@northwestern.edu
-
Danville, Illinois, United States, 61832
- Recruiting
- Carle on Vermilion
-
Principal Investigator:
- Suparna Mantha
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Decatur, Illinois, United States, 62526
- Recruiting
- Cancer Care Specialists of Illinois - Decatur
-
Principal Investigator:
- Bryan A. Faller
-
Contact:
- Site Public Contact
- Phone Number: 217-876-4740
- Email: rhamrick@dmhhs.org
-
Galesburg, Illinois, United States, 61401
- Recruiting
- Illinois CancerCare-Galesburg
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Mattoon, Illinois, United States, 61938
- Recruiting
- Carle Physician Group-Mattoon/Charleston
-
Principal Investigator:
- Suparna Mantha
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Normal, Illinois, United States, 61761
- Recruiting
- Carle BroMenn Medical Center
-
Contact:
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Suparna Mantha
-
Normal, Illinois, United States, 61761
- Recruiting
- Carle Cancer Institute Normal
-
Contact:
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Principal Investigator:
- Suparna Mantha
-
Ottawa, Illinois, United States, 61350
- Recruiting
- Illinois CancerCare-Ottawa Clinic
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Pekin, Illinois, United States, 61554
- Recruiting
- Illinois CancerCare-Pekin
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Peoria, Illinois, United States, 61615
- Recruiting
- Illinois CancerCare-Peoria
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Peru, Illinois, United States, 61354
- Recruiting
- Illinois CancerCare-Peru
-
Contact:
- Site Public Contact
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A. Faller
-
Urbana, Illinois, United States, 61801
- Recruiting
- Carle Cancer Center
-
Principal Investigator:
- Suparna Mantha
-
Contact:
- Site Public Contact
- Phone Number: 800-446-5532
- Email: Research@carle.com
-
Washington, Illinois, United States, 61571
- Recruiting
- Illinois CancerCare - Washington
-
Contact:
- Phone Number: 309-243-3605
- Email: andersonj@illinoiscancercare.com
-
Principal Investigator:
- Bryan A Faller
-
-
Iowa
-
Cedar Rapids, Iowa, United States, 52402
- Recruiting
- Physicians' Clinic of Iowa PC
-
Contact:
- Phone Number: 319-297-2900
-
Principal Investigator:
- William P Fusselman
-
Des Moines, Iowa, United States, 50309
- Recruiting
- Medical Oncology and Hematology Associates-Des Moines
-
Contact:
- Site Public Contact
- Phone Number: 515-282-2921
-
Principal Investigator:
- Robert J. Behrens
-
Des Moines, Iowa, United States, 50314
- Recruiting
- Broadlawns Medical Center
-
Contact:
- Site Public Contact
- Phone Number: 515-282-2200
-
Principal Investigator:
- Robert J. Behrens
-
Des Moines, Iowa, United States, 50314
- Recruiting
- Mercy Medical Center - Des Moines
-
Principal Investigator:
- Richard L Deming
-
Contact:
- Phone Number: 515-358-6613
- Email: cancerresearch@mercydesmoines.org
-
-
Kentucky
-
Bardstown, Kentucky, United States, 40004
- Recruiting
- Flaget Memorial Hospital
-
Principal Investigator:
- Richard L Deming
-
Contact:
- Phone Number: 859-629-7169
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Lexington, Kentucky, United States, 40509
- Recruiting
- Saint Joseph Hospital East
-
Principal Investigator:
- Richard L Deming
-
Contact:
- Phone Number: 859-629-7169
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
Lexington, Kentucky, United States, 40504
- Recruiting
- Saint Joseph Radiation Oncology Resource Center
-
Principal Investigator:
- Richard L Deming
-
Contact:
- Phone Number: 859-629-7169
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
London, Kentucky, United States, 40741
- Recruiting
- Saint Joseph London
-
Principal Investigator:
- Richard L Deming
-
Contact:
- Phone Number: 859-629-7169
- Email: ResearchInstituteInquiries@CommonSpirit.org
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70836
- Recruiting
- Ochsner High Grove
-
Contact:
- Phone Number: 225-761-5346
- Email: Camielle.beck@ochsner.org
-
Principal Investigator:
- John T Cole
-
Kenner, Louisiana, United States, 70065
- Recruiting
- Ochsner Medical Center Kenner
-
Principal Investigator:
- John T Cole
-
Contact:
- Phone Number: 504-464-8789
- Email: awendt@ochsner.org
-
New Orleans, Louisiana, United States, 70121
- Recruiting
- Ochsner Medical Center Jefferson
-
Principal Investigator:
- John T Cole
-
Contact:
- Phone Number: 504-842-8084
- Email: Elisemarie.curry@ochsner.org
-
Shreveport, Louisiana, United States, 71105
- Recruiting
- CHRISTUS Highland Medical Center
-
Principal Investigator:
- John T Cole
-
Contact:
- Phone Number: 318-681-4763
- Email: Nancy.hassan@christushealth.org
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- Recruiting
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Contact:
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Brighton, Michigan, United States, 48114
- Recruiting
- Trinity Health Medical Center - Brighton
-
Principal Investigator:
- Tareq Al Baghdadi
-
Canton, Michigan, United States, 48118
- Recruiting
- Trinity Health Medical Center - Canton
-
Contact:
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Chelsea, Michigan, United States, 48118
- Recruiting
- Chelsea Hospital
-
Contact:
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesee Cancer and Blood Disease Treatment Center
-
Contact:
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesee Hematology Oncology PC
-
Contact:
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Flint, Michigan, United States, 48503
- Recruiting
- Genesys Hurley Cancer Institute
-
Contact:
- Phone Number: 810-762-8038
- Email: wstrong@ghci.org
-
Principal Investigator:
- Tareq Al Baghdadi
-
Livonia, Michigan, United States, 48154
- Recruiting
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Contact:
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Tareq Tareq
-
Pontiac, Michigan, United States, 48341
- Recruiting
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Contact:
- Phone Number: 734-712-7251
- Email: MCRCwebsitecontactform@stjoeshealth.org
-
Principal Investigator:
- Samir Narayan
-
-
Minnesota
-
Coon Rapids, Minnesota, United States, 55433
- Recruiting
- Mercy Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Edina, Minnesota, United States, 55435
- Recruiting
- Fairview Southdale Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Maplewood, Minnesota, United States, 55109
- Recruiting
- Saint John's Hospital - Healtheast
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Minneapolis, Minnesota, United States, 55407
- Recruiting
- Abbott-Northwestern Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamela A Pawloski
-
Robbinsdale, Minnesota, United States, 55422
- Recruiting
- North Memorial Medical Health Center
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Saint Louis Park, Minnesota, United States, 55416
- Recruiting
- Park Nicollet Clinic - Saint Louis Park
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Saint Paul, Minnesota, United States, 55101
- Recruiting
- Regions Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamela A Pawloski
-
Saint Paul, Minnesota, United States, 55102
- Recruiting
- United Hospital
-
Principal Investigator:
- Pamala A. Pawloski
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Stillwater, Minnesota, United States, 55082
- Recruiting
- Lakeview Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Willmar, Minnesota, United States, 56201
- Recruiting
- Rice Memorial Hospital
-
Contact:
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
Principal Investigator:
- Pamala A Pawloski
-
Woodbury, Minnesota, United States, 55125
- Recruiting
- Minnesota Oncology Hematology PA-Woodbury
-
Principal Investigator:
- Pamala A. Pawloski
-
Contact:
- Site Public Contact
- Phone Number: 952-993-1517
- Email: mmcorc@healthpartners.com
-
-
Missouri
-
Bolivar, Missouri, United States, 65613
- Recruiting
- Central Care Cancer Center - Bolivar
-
Principal Investigator:
- Jay W Carlson
-
Contact:
- Phone Number: 913-948-5588
- Email: aroland@kccop.org
-
Saint Joseph, Missouri, United States, 64506
- Recruiting
- Heartland Regional Medical Center
-
Principal Investigator:
- Jay W Carlson
-
Contact:
- Phone Number: 816-271-7937
- Email: linda.schumacher@mymlc.com
-
-
New Jersey
-
Freehold, New Jersey, United States, 07728
- Recruiting
- CentraState Medical Center
-
Principal Investigator:
- Alexander Itskovich
-
Contact:
- Phone Number: 732-303-5047
-
Hackettstown, New Jersey, United States, 07840
- Recruiting
- Hackettstown Medical Center
-
Contact:
- Phone Number: 973-971-5990
-
Principal Investigator:
- Anjali Varma Desai
-
Morristown, New Jersey, United States, 07960
- Recruiting
- Morristown Medical Center
-
Contact:
- Phone Number: 908-522-2043
-
Principal Investigator:
- Anjali Varma Desai
-
New Brunswick, New Jersey, United States, 08901
- Recruiting
- Saint Peter's University Hospital
-
Contact:
- Phone Number: 6163 732-745-8600
- Email: kcovert@saintpetersuh.com
-
Principal Investigator:
- Valerie Shander
-
Newton, New Jersey, United States, 07860
- Recruiting
- Newton Medical Center
-
Contact:
- Phone Number: 973-971-5990
-
Principal Investigator:
- Anjali Varma Desai
-
Pompton, New Jersey, United States, 07444
- Recruiting
- Chilton Medical Center
-
Contact:
- Phone Number: 973-971-5990
-
Principal Investigator:
- Anjali Varma Desai
-
Summit, New Jersey, United States, 07901
- Recruiting
- Overlook Medical Center
-
Contact:
- Phone Number: 908-522-2043
-
Principal Investigator:
- Anjali Varma Desai
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Recruiting
- Wake Forest University Health Sciences
-
Contact:
- Phone Number: 336-713-6771
-
Principal Investigator:
- Thomas Lycan
-
-
Ohio
-
Columbus, Ohio, United States, 43219
- Recruiting
- The Mark H Zangmeister Center
-
Principal Investigator:
- Timothy D Moore
-
Contact:
- Phone Number: 614-488-2118
- Email: sheree@columbusccop.org
-
Mount Vernon, Ohio, United States, 43050
- Recruiting
- Knox Community Hospital
-
Principal Investigator:
- Timothy D Moore
-
Contact:
- Phone Number: 740-393-9000
- Email: sheree@columbusccop.org
-
Portsmouth, Ohio, United States, 45662
- Recruiting
- Southern Ohio Medical Center
-
Principal Investigator:
- Timothy D Moore
-
Contact:
- Phone Number: 614-488-2118
- Email: sheree@columbusccop.org
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Recruiting
- Geisinger Medical Center
-
Contact:
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Fiori Alite
-
Hazleton, Pennsylvania, United States, 18201
- Recruiting
- Geisinger Medical Center-Cancer Center Hazleton
-
Principal Investigator:
- Fiori Alite
-
Contact:
- Phone Number: 570-459-2901
- Email: HemonCCTrials@geisinger.edu
-
Lewisburg, Pennsylvania, United States, 17837
- Recruiting
- Geisinger Medical Oncology-Lewisburg
-
Principal Investigator:
- Fiori Alite
-
Contact:
- Phone Number: 570-374-8555
- Email: HemonCCTrials@geisinger.edu
-
Pottsville, Pennsylvania, United States, 17901
- Recruiting
- Geisinger Cancer Services-Pottsville
-
Principal Investigator:
- Fiori Alite
-
Contact:
- Phone Number: 800-275-6401
- Email: HemonCCTrials@geisinger.edu
-
Scranton, Pennsylvania, United States, 18510
- Recruiting
- Community Medical Center
-
Principal Investigator:
- Fiori Alite
-
Contact:
- Phone Number: 570-703-4768
- Email: HemonCCTrials@geisinger.edu
-
Wilkes-Barre, Pennsylvania, United States, 18711
- Recruiting
- Geisinger Wyoming Valley/Henry Cancer Center
-
Contact:
- Phone Number: 570-271-5251
- Email: HemonCCTrials@geisinger.edu
-
Principal Investigator:
- Fiori Alite
-
-
South Carolina
-
Bluffton, South Carolina, United States, 29910
- Recruiting
- Saint Joseph's/Candler - Bluffton Campus
-
Contact:
- Phone Number: 912-819-5704
- Email: underberga@sjchs.org
-
Principal Investigator:
- Mark A Taylor
-
Boiling Springs, South Carolina, United States, 29316
- Recruiting
- Prisma Health Cancer Institute - Spartanburg
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Charleston, South Carolina, United States, 29425
- Recruiting
- Medical University of South Carolina
-
Principal Investigator:
- Sarah T. Price
-
Contact:
- Site Public Contact
- Phone Number: 843-792-9321
- Email: hcc-clinical-trials@musc.edu
-
Easley, South Carolina, United States, 29640
- Recruiting
- Prisma Health Cancer Institute - Easley
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Georgetown, South Carolina, United States, 29440
- Recruiting
- Tidelands Georgetown Memorial Hospital
-
Principal Investigator:
- Sarah T. Price
-
Contact:
- Site Public Contact
- Phone Number: 843-545-5600
- Email: broe@tidelandshealth.org
-
Greenville, South Carolina, United States, 29605
- Recruiting
- Prisma Health Cancer Institute - Faris
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Greenville, South Carolina, United States, 29605
- Recruiting
- Prisma Health Cancer Institute - Butternut
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Greenville, South Carolina, United States, 29615
- Recruiting
- Prisma Health Cancer Institute - Eastside
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Greer, South Carolina, United States, 29650
- Recruiting
- Prisma Health Cancer Institute - Greer
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
Hilton Head Island, South Carolina, United States, 29926
- Recruiting
- South Carolina Cancer Specialists PC
-
Contact:
- Phone Number: 912-819-5704
- Email: underberga@sjchs.org
-
Principal Investigator:
- Mark A Taylor
-
Seneca, South Carolina, United States, 29672
- Recruiting
- Prisma Health Cancer Institute - Seneca
-
Principal Investigator:
- Jeffrey K. Giguere
-
Contact:
- Site Public Contact
- Phone Number: 864-522-2066
- Email: Kim.Williams3@prismahealth.org
-
-
Virginia
-
Gloucester, Virginia, United States, 23061
- Recruiting
- Peninsula Cancer Institute - Gloucester
-
Contact:
- Phone Number: 757-534-5565
- Email: oramae.jackson@rivhs.com
-
Principal Investigator:
- Suzanne Ameringer
-
Newport News, Virginia, United States, 23601
- Recruiting
- Peninsula Cancer Institute - Newport News
-
Contact:
- Phone Number: 757-534-5565
- Email: oramae.jackson@rivhs.com
-
Principal Investigator:
- Suzanne Ameringer
-
Richmond, Virginia, United States, 23298
- Recruiting
- Virginia Commonwealth University/Massey Cancer Center
-
Contact:
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Suzanne W W Ameringer
-
Richmond, Virginia, United States, 23235
- Recruiting
- VCU Massey Cancer Center at Stony Point
-
Contact:
- Email: CTOclinops@vcu.edu
-
Principal Investigator:
- Suzanne W Ameringer
-
South Hill, Virginia, United States, 23970
- Recruiting
- VCU Community Memorial Health Center
-
Principal Investigator:
- Suzanne W Ameringer
-
Contact:
- Phone Number: 434-774-2442
- Email: sherman.baker@vcuhealth.org
-
Virginia Beach, Virginia, United States, 23235
- Recruiting
- Peninsula Cancer Institute - Cancer Specialists of Tidewater
-
Principal Investigator:
- Suzanne Ameringer
-
Williamsburg, Virginia, United States, 23185
- Recruiting
- Peninsula Cancer Institute - Williamsburg
-
Contact:
- Phone Number: 757-534-5565
- Email: oramae.jackson@rivhs.com
-
Principal Investigator:
- Suzanne Ameringer
-
-
Wisconsin
-
Chippewa Falls, Wisconsin, United States, 54729
- Recruiting
- Marshfield Clinic-Chippewa Center
-
Contact:
- Phone Number: 94457 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A Delmastro
-
Eau Claire, Wisconsin, United States, 54701
- Recruiting
- Marshfield Medical Center-EC Cancer Center
-
Principal Investigator:
- Dean A Delmastro
-
Contact:
- Phone Number: 16119 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Ladysmith, Wisconsin, United States, 54848
- Recruiting
- Marshfield Medical Center - Ladysmith
-
Principal Investigator:
- Dean A Delmastro
-
Contact:
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Marshfield, Wisconsin, United States, 54449
- Recruiting
- Marshfield Medical Center-Marshfield
-
Contact:
- Phone Number: 94457 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A Delmastro
-
Minocqua, Wisconsin, United States, 54548
- Recruiting
- Marshfield Medical Center - Minocqua
-
Contact:
- Phone Number: 94457 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A Delmastro
-
Neillsville, Wisconsin, United States, 54456
- Recruiting
- Marshfield Medical Center - Neillsville
-
Principal Investigator:
- Dean A Delmastro
-
Contact:
- Phone Number: 7-5416 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Rice Lake, Wisconsin, United States, 54868
- Recruiting
- Marshfield Medical Center-Rice Lake
-
Contact:
- Phone Number: 94457 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A Delmastro
-
Stevens Point, Wisconsin, United States, 54482
- Recruiting
- Marshfield Medical Center-River Region at Stevens Point
-
Principal Investigator:
- Dean A Delmastro
-
Contact:
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Wausau, Wisconsin, United States, 54401
- Recruiting
- Marshfield Clinic-Wausau Center
-
Contact:
- Phone Number: 94457 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A Delmastro
-
Weston, Wisconsin, United States, 54476
- Recruiting
- Marshfield Medical Center - Weston
-
Contact:
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
Principal Investigator:
- Dean A, Delmastro
-
Wisconsin Rapids, Wisconsin, United States, 54494
- Recruiting
- Marshfield Clinic - Wisconsin Rapids Center
-
Principal Investigator:
- Dean A Delmastro
-
Contact:
- Phone Number: 800-782-8581
- Email: oncology.clinical.trials@marshfieldresearch.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity
Time Frame: Change from Baseline to 10 week
|
The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
|
Change from Baseline to 10 week
|
Pain Interference
Time Frame: Change from Baseline to 10 week
|
The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
|
Change from Baseline to 10 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Severity
Time Frame: 22 and 34 weeks
|
The Pain Severity via Brief Pain Inventory (BPI) subscale score is the mean of 4 items measuring current pain, pain on average, and pain at its worst and least in the past 7 days on a scale from 0 (no pain) to 10 (pain as bad as you can imagine).
|
22 and 34 weeks
|
Pain Interference
Time Frame: 22 and 34 weeks
|
The Pain Interference via Brief Pain Inventory (BPI) subscale score is the mean rating of 7 items measuring impact of pain on walking, work, mood, enjoyment of life, relations with others, sleep, general activity on a scale from 0 (does not interfere) to 10 (completely interferes).
|
22 and 34 weeks
|
Opioid/analgesic medication use
Time Frame: Baseline and 10 week
|
A participant recall during clinic visits of typical daily medication use.
This will be converted to morphine milligram equivalents (MME).
|
Baseline and 10 week
|
Opioid/analgesic medication use
Time Frame: Baseline, 10, 22, and 24 week
|
7-day medication diaries to capture participants' use of all medications each day during a 7-day period.
Self-reports will be converted to morphine milligram equivalents (MME).
|
Baseline, 10, 22, and 24 week
|
Health-Related Quality of Life
Time Frame: Baseline, 10, 22, and 24 week
|
Health-Related Quality of Life will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (Short Form-6b).
The six items are summed to give a score from 6 to 30, with higher scores representing better physical function.
|
Baseline, 10, 22, and 24 week
|
Pain Management Self-Efficacy
Time Frame: Baseline, 10, 22, and 24 week
|
Pain Management Self-Efficacy will be assessed with the Chronic Pain Self-Efficacy Scale.
The self-efficacy for pain management subscale (PSE) consists of five items summed to give a score from 50-500, the self-efficacy for physical function subscale (FSE) consists of nine items summed to give a score from 90-900, and the self-efficacy for coping with symptoms subscale (CSE) consists of eight items summed to give a score from 80-800.
For all subscales, higher scores represent greater self-efficacy.
|
Baseline, 10, 22, and 24 week
|
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Glenn Lesser, MD, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB00066906
- 3UG1CA189824-06S1 (U.S. NIH Grant/Contract)
- WF-1901 (Other Identifier: Wake Forest NCORP Research Base)
- NCI-2020-02315 (Registry Identifier: NCI CTRP (Clinical Trial Reporting Program))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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