Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
Status: Recruiting
Location: See all (130) locations...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with stage I-IV cancer who are receiving cancer treatment. Cancer treatment can cause side effects such as sleep problems. Sleep problems such as insomnia, are common for cancer patients. Insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. Insomnia can increase fatigue and worsen quality of life. This trial may help researchers determine which treatment works better in reducing insomnia, BBT-CI or HEAL.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Be at least 18 years of age
• Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
• Be currently receiving any cancer treatment (surgery alone is excluded)
• Report sleep disturbance of 3 or greater on the sleep disturbance question: Rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems
• Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
• Be able to speak, understand and read English to participate in the study assessments and interventions
Locations
United States
Arkansas
Mercy Hospital Fort Smith
RECRUITING
Fort Smith
Arizona
Kingman Regional Medical Center
RECRUITING
Kingman
California
Kaiser Permanente NCORP
RECRUITING
Oakland
Colorado
Kaiser Permanente-Franklin
RECRUITING
Denver
Kaiser Permanente-Rock Creek
RECRUITING
Lafayette
Kaiser Permanente-Lone Tree
RECRUITING
Lone Tree
Delaware
Beebe South Coastal Health Campus
RECRUITING
Frankford
Helen F Graham Cancer Center
RECRUITING
Newark
Medical Oncology Hematology Consultants PA
RECRUITING
Newark
Beebe Health Campus
RECRUITING
Rehoboth Beach
Hawaii
Hawaii Cancer Care - Westridge
RECRUITING
‘aiea
Pali Momi Medical Center
RECRUITING
‘aiea
Hawaii Cancer Care Inc - Waterfront Plaza
RECRUITING
Honolulu
Hawaii Minority Underserved NCORP
RECRUITING
Honolulu
Kapiolani Medical Center for Women and Children
RECRUITING
Honolulu
Queen's Cancer Center - Kuakini
RECRUITING
Honolulu
Queen's Cancer Center - POB I
RECRUITING
Honolulu
Queen's Medical Center
RECRUITING
Honolulu
Straub Clinic and Hospital
RECRUITING
Honolulu
University of Hawaii Cancer Center
RECRUITING
Honolulu
Iowa
Physicians' Clinic of Iowa PC
RECRUITING
Cedar Rapids
Iowa Methodist Medical Center
RECRUITING
Des Moines
Mission Cancer and Blood - Des Moines
RECRUITING
Des Moines
Illinois
Illinois CancerCare-Bloomington
RECRUITING
Bloomington
Illinois CancerCare-Canton
RECRUITING
Canton
Memorial Hospital of Carbondale
RECRUITING
Carbondale
SIH Cancer Institute
RECRUITING
Carterville
Centralia Oncology Clinic
RECRUITING
Centralia
Carle at The Riverfront
RECRUITING
Danville
Cancer Care Specialists of Illinois - Decatur
RECRUITING
Decatur
Decatur Memorial Hospital
RECRUITING
Decatur
Heartland Cancer Research NCORP
RECRUITING
Decatur
Heartland Cancer Research NCORP
RECRUITING
Decatur
Crossroads Cancer Center
RECRUITING
Effingham
Illinois CancerCare-Galesburg
RECRUITING
Galesburg
Cancer Care Center of O'Fallon
RECRUITING
O'fallon
Illinois CancerCare-Pekin
RECRUITING
Pekin
Illinois CancerCare-Peoria
RECRUITING
Peoria
Carle Cancer Center NCORP
RECRUITING
Urbana
Illinois CancerCare - Washington
RECRUITING
Washington
Louisiana
Louisiana State University Health Science Center
RECRUITING
New Orleans
University Medical Center New Orleans
RECRUITING
New Orleans
Maryland
Christiana Care - Union Hospital
RECRUITING
Elkton
Michigan
Spectrum Health at Butterworth Campus
RECRUITING
Grand Rapids
Minnesota
Minnesota Oncology - Burnsville
RECRUITING
Burnsville
Mercy Hospital
RECRUITING
Coon Rapids
Fairview Southdale Hospital
RECRUITING
Edina
Minnesota Oncology Hematology PA-Maplewood
RECRUITING
Maplewood
Saint John's Hospital - Healtheast
RECRUITING
Maplewood
Abbott-Northwestern Hospital
RECRUITING
Minneapolis
Hennepin County Medical Center
RECRUITING
Minneapolis
Metro Minnesota Community Oncology Research Consortium
RECRUITING
Minneapolis
Monticello Cancer Center
RECRUITING
Monticello
New Ulm Medical Center
RECRUITING
New Ulm
Park Nicollet Clinic - Saint Louis Park
RECRUITING
Saint Louis Park
Regions Hospital
RECRUITING
Saint Paul
United Hospital
RECRUITING
Saint Paul
Saint Francis Regional Medical Center
RECRUITING
Shakopee
Rice Memorial Hospital
RECRUITING
Willmar
Minnesota Oncology Hematology PA-Woodbury
RECRUITING
Woodbury
Fairview Lakes Medical Center
RECRUITING
Wyoming
Missouri
Saint Louis Cancer and Breast Institute-Ballwin
RECRUITING
Ballwin
Mercy Hospital Joplin
RECRUITING
Joplin
Cancer Research for the Ozarks NCORP
RECRUITING
Springfield
Mercy Hospital Springfield
RECRUITING
Springfield
Mercy Hospital Saint Louis
RECRUITING
St Louis
Mercy Hospital South
RECRUITING
St Louis
North Carolina
Outer Banks Hospital
RECRUITING
Nags Head
Southeast Clinical Oncology Research Consortium
RECRUITING
Winston-salem
Nevada
Comprehensive Cancer Centers of Nevada - Henderson
RECRUITING
Henderson
Comprehensive Cancer Centers of Nevada-Southeast Henderson
RECRUITING
Henderson
OptumCare Cancer Care at Seven Hills
RECRUITING
Henderson
Urology Specialists of Nevada - Green Valley
RECRUITING
Henderson
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Central Valley
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Northwest
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada - Town Center
RECRUITING
Las Vegas
Comprehensive Cancer Centers of Nevada-Summerlin
RECRUITING
Las Vegas
Nevada Cancer Research Foundation NCORP
RECRUITING
Las Vegas
OptumCare Cancer Care at Charleston
RECRUITING
Las Vegas
OptumCare Cancer Care at Fort Apache
RECRUITING
Las Vegas
OptumCare Cancer Care at MountainView
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Urology Specialists of Nevada - Northwest
RECRUITING
Las Vegas
Urology Specialists of Nevada - Southwest
RECRUITING
Las Vegas
Marietta Memorial Hospital
RECRUITING
Marietta
Ohio
Strecker Cancer Center-Belpre
RECRUITING
Belpre
Mount Carmel East Hospital
RECRUITING
Columbus
The Mark H Zangmeister Center
RECRUITING
Columbus
Delaware/Christiana Care NCORP
RECRUITING
Dayton
Mount Carmel Grove City Hospital
RECRUITING
Grove City
Knox Community Hospital
RECRUITING
Mount Vernon
Licking Memorial Hospital
RECRUITING
Newark
Saint Ann's Hospital
RECRUITING
Westerville
Oregon
Providence Newberg Medical Center
RECRUITING
Newberg
Providence Willamette Falls Medical Center
RECRUITING
Oregon City
Providence Portland Medical Center
RECRUITING
Portland
Providence Saint Vincent Medical Center
RECRUITING
Portland
Pennsylvania
Christiana Care Health System-Concord Health Center
RECRUITING
Chadds Ford
Geisinger Medical Center
RECRUITING
Danville
Geisinger Cancer Institute NCORP
RECRUITING
Dayton
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
Bon Secours Saint Francis Hospital
RECRUITING
Charleston
Charleston Oncology - Roper
RECRUITING
Charleston
Charleston Oncology - Saint Francis
RECRUITING
Charleston
Lowcountry Hematology Oncology PA-North Charleston
RECRUITING
Charleston
Lowcountry Hematology Oncology PA-West Ashley
RECRUITING
Charleston
Roper Hospital
RECRUITING
Charleston
Lowcountry Hematology Oncology PA-Mount Pleasant
RECRUITING
Mt. Pleasant
Virginia
Chesapeake Regional Medical Center
RECRUITING
Chesapeake
Hematology Oncology Associates of Fredericksburg Inc
RECRUITING
Fredericksburg
Centra Lynchburg Hematology-Oncology Clinic Inc
RECRUITING
Lynchburg
VCU Massey Cancer Center at Stony Point
RECRUITING
Richmond
Virginia Cancer Institute
RECRUITING
Richmond
Virginia Commonwealth University/Massey Cancer Center
RECRUITING
Richmond
VCU Community Memorial Health Center
RECRUITING
South Hill
Shenandoah Oncology PC
RECRUITING
Winchester
Washington
PeaceHealth Saint Joseph Medical Center
RECRUITING
Bellingham
PeaceHealth United General Medical Center
RECRUITING
Sedro-woolley
Wisconsin
ThedaCare Regional Cancer Center
RECRUITING
Appleton
HSHS Sacred Heart Hospital
RECRUITING
Eau Claire
Cancer Research of Wisconsin and Northern Michigan Consortium
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center at Saint Mary's
RECRUITING
Green Bay
Saint Vincent Hospital Cancer Center Green Bay
RECRUITING
Green Bay
Westfields Hospital/Cancer Center of Western Wisconsin
RECRUITING
New Richmond
Time Frame
Start Date: 2021-06-24
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 400
Treatments
Experimental: Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Active_comparator: Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Related Therapeutic Areas
Sponsors
Leads: University of Rochester NCORP Research Base
Collaborators: National Cancer Institute (NCI)