Internet-delivered Management of Pain Among Cancer Treatment Survivors

Status: Recruiting
Location: See all (150) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

∙ 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.

Locations
United States
Arkansas
Mercy Hospital Fort Smith
RECRUITING
Fort Smith
California
Kaiser Permanente-Deer Valley Medical Center
RECRUITING
Antioch
Kaiser Permanente Dublin
RECRUITING
Dublin
Kaiser Permanente-Fremont
RECRUITING
Fremont
Kaiser Permanente-Fresno
RECRUITING
Fresno
Kaiser Permanente-Modesto
RECRUITING
Modesto
Kaiser Permanente-Oakland
RECRUITING
Oakland
Kaiser Permanente- Marshall Medical Offices
RECRUITING
Redwood City
Kaiser Permanente-Richmond
RECRUITING
Richmond
Kaiser Permanente-Roseville
RECRUITING
Roseville
Kaiser Permanente Downtown Commons
RECRUITING
Sacramento
Kaiser Permanente-South Sacramento
RECRUITING
Sacramento
Kaiser Permanente-San Francisco
RECRUITING
San Francisco
Kaiser Permanente-Santa Teresa-San Jose
RECRUITING
San Jose
Kaiser Permanente San Leandro
RECRUITING
San Leandro
Kaiser San Rafael-Gallinas
RECRUITING
San Rafael
Kaiser Permanente Medical Center - Santa Clara
RECRUITING
Santa Clara
Kaiser Permanente-Santa Rosa
RECRUITING
Santa Rosa
Kaiser Permanente-South San Francisco
RECRUITING
South San Francisco
Kaiser Permanente-Stockton
RECRUITING
Stockton
Kaiser Permanente Medical Center-Vacaville
RECRUITING
Vacaville
Kaiser Permanente-Vallejo
RECRUITING
Vallejo
Colorado
Kaiser Permanente-Franklin
RECRUITING
Denver
Kaiser Permanente-Rock Creek
RECRUITING
Lafayette
Kaiser Permanente-Lone Tree
RECRUITING
Lone Tree
Georgia
John B. Amos Cancer Center
RECRUITING
Columbus
Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
RECRUITING
Savannah
Hawaii
Hawaii Cancer Care - Savio
RECRUITING
‘aiea
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
Pali Momi Medical Center
RECRUITING
‘aiea
The Cancer Center of Hawaii-Pali Momi
RECRUITING
‘aiea
The Queen's Medical Center - West Oahu
RECRUITING
‘ewa Beach
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Kaiser Permanente Moanalua Medical Center
RECRUITING
Honolulu
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Queen's Cancer Cenrer - POB I
RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
RECRUITING
Honolulu
Queen's Medical Center
RECRUITING
Honolulu
Straub Clinic and Hospital
RECRUITING
Honolulu
The Cancer Center of Hawaii-Liliha
RECRUITING
Honolulu
Tripler Army Medical Center
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Iowa
UI Health Care Mission Cancer and Blood - Ankeny Clinic
RECRUITING
Ankeny
Physicians' Clinic of Iowa PC
RECRUITING
Cedar Rapids
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
RECRUITING
Clive
Broadlawns Medical Center
RECRUITING
Des Moines
Medical Oncology and Hematology Associates-Des Moines
RECRUITING
Des Moines
Mercy Medical Center - Des Moines
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Laurel Clinic
RECRUITING
Des Moines
UI Health Care Mission Cancer and Blood - Waukee Clinic
RECRUITING
Waukee
Illinois
Carle BroMenn Outpatient Center
RECRUITING
Bloomington
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Northwestern University
RECRUITING
Chicago
Carle at The Riverfront
RECRUITING
Danville
Carle on Vermilion
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Carle Physician Group-Mattoon/Charleston
RECRUITING
Mattoon
Carle BroMenn Medical Center
RECRUITING
Normal
Carle Cancer Institute Normal
RECRUITING
Normal
Illinois CancerCare-Ottawa Clinic
RECRUITING
Ottawa
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Illinois CancerCare-Peru
RECRUITING
Peru
Carle Cancer Center
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Kentucky
Flaget Memorial Hospital
RECRUITING
Bardstown
Saint Joseph Hospital East
RECRUITING
Lexington
Saint Joseph Radiation Oncology Resource Center
RECRUITING
Lexington
Saint Joseph London
RECRUITING
London
Louisiana
Ochsner Baptist Medical Center
RECRUITING
New Orleans
Ochsner Medical Center Jefferson
RECRUITING
New Orleans
CHRISTUS Highland Medical Center
RECRUITING
Shreveport
Maine
MaineHealth Cancer Care Center of York County
RECRUITING
Sanford
Michigan
Trinity Health Saint Joseph Mercy Hospital Ann Arbor
RECRUITING
Ann Arbor
Trinity Health Medical Center - Brighton
RECRUITING
Brighton
Trinity Health Medical Center - Canton
RECRUITING
Canton
Chelsea Hospital
RECRUITING
Chelsea
Genesee Cancer and Blood Disease Treatment Center
RECRUITING
Flint
Genesee Hematology Oncology PC
RECRUITING
Flint
Genesys Hurley Cancer Institute
RECRUITING
Flint
Marshfield Medical Center Dickinson
RECRUITING
Iron Mountain
Trinity Health Saint Mary Mercy Livonia Hospital
RECRUITING
Livonia
Trinity Health Saint Joseph Mercy Oakland Hospital
RECRUITING
Pontiac
Minnesota
Mercy Hospital
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
North Memorial Medical Health Center
RECRUITING
Robbinsdale
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Lakeview Hospital
RECRUITING
Stillwater
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Missouri
Central Care Cancer Center - Bolivar
RECRUITING
Bolivar
Heartland Regional Medical Center
RECRUITING
Saint Joseph
North Carolina
Wake Forest University at Clemmons
RECRUITING
Clemmons
Wake Forest University at Lexington
RECRUITING
Lexington
Wake Forest University Health Sciences
RECRUITING
Winston-salem
New Jersey
CentraState Medical Center
RECRUITING
Freehold
Hackettstown Medical Center
RECRUITING
Hackettstown
Morristown Medical Center
RECRUITING
Morristown
Saint Peter's University Hospital
RECRUITING
New Brunswick
Newton Medical Center
RECRUITING
Newton
Chilton Medical Center
RECRUITING
Pompton
Overlook Medical Center
RECRUITING
Summit
Ohio
The Mark H Zangmeister Center
RECRUITING
Columbus
Memorial Hospital
RECRUITING
Marysville
Knox Community Hospital
RECRUITING
Mount Vernon
Southern Ohio Medical Center
RECRUITING
Portsmouth
Pennsylvania
Geisinger Medical Center
RECRUITING
Danville
Geisinger Medical Center-Cancer Center Hazleton
RECRUITING
Hazleton
Geisinger Medical Oncology-Lewisburg
RECRUITING
Lewisburg
Geisinger Cancer Services-Pottsville
RECRUITING
Pottsville
Community Medical Center
RECRUITING
Scranton
Geisinger Wyoming Valley/Henry Cancer Center
RECRUITING
Wilkes-barre
South Carolina
Saint Joseph's/Candler - Bluffton Campus
RECRUITING
Bluffton
Prisma Health Cancer Institute - Spartanburg
RECRUITING
Boiling Springs
Medical University of South Carolina
RECRUITING
Charleston
Prisma Health Cancer Institute - Easley
RECRUITING
Easley
Tidelands Georgetown Memorial Hospital
RECRUITING
Georgetown
Prisma Health Cancer Institute - Butternut
RECRUITING
Greenville
Prisma Health Cancer Institute - Eastside
RECRUITING
Greenville
Prisma Health Cancer Institute - Faris
RECRUITING
Greenville
Self Regional Healthcare
RECRUITING
Greenwood
Prisma Health Cancer Institute - Greer
RECRUITING
Greer
South Carolina Cancer Specialists PC
RECRUITING
Hilton Head Island
Prisma Health Cancer Institute - Seneca
RECRUITING
Seneca
Virginia
Peninsula Cancer Institute - Gloucester
RECRUITING
Gloucester
Peninsula Cancer Institute - Newport News
RECRUITING
Newport News
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
VCU Community Memorial Health Center
RECRUITING
South Hill
Peninsula Cancer Institute - Cancer Specialists of Tidewater
RECRUITING
Virginia Beach
Peninsula Cancer Institute - Williamsburg
RECRUITING
Williamsburg
Wisconsin
Marshfield Clinic-Chippewa Center
RECRUITING
Chippewa Falls
Marshfield Medical Center-EC Cancer Center
RECRUITING
Eau Claire
Marshfield Medical Center - Ladysmith
RECRUITING
Ladysmith
Marshfield Medical Center-Marshfield
RECRUITING
Marshfield
Marshfield Medical Center - Minocqua
RECRUITING
Minocqua
Marshfield Medical Center - Neillsville
RECRUITING
Neillsville
Marshfield Medical Center-Rice Lake
RECRUITING
Rice Lake
Marshfield Medical Center-River Region at Stevens Point
RECRUITING
Stevens Point
Marshfield Clinic-Wausau Center
RECRUITING
Wausau
Marshfield Medical Center - Weston
RECRUITING
Weston
Marshfield Clinic - Wisconsin Rapids Center
RECRUITING
Wisconsin Rapids
Other Locations
Guam
FHP Health Center-Guam
RECRUITING
Tamuning
Contact Information
Primary
Karen Craver
NCORP@wakehealth.edu
336-716-0891
Time Frame
Start Date: 2021-05-13
Estimated Completion Date: 2026-08-31
Participants
Target number of participants: 456
Treatments
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.
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.
Authors
Christine Rini, William P Fusselman
Related Therapeutic Areas
Sponsors
Leads: Wake Forest University Health Sciences
Collaborators: National Cancer Institute (NCI), National Institute of Neurological Disorders and Stroke (NINDS)

This content was sourced from clinicaltrials.gov