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RECRUITING
NCT04829539
PHASE3

Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment

Sponsor: University of Rochester NCORP Research Base

View on ClinicalTrials.gov

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.

Official title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2021-06-24

Completion Date

2026-12-16

Last Updated

2025-10-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Behavioral Intervention

Receive BBT-CI

BEHAVIORAL

Behavioral Intervention

Receive HEAL

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (153)

Kingman Regional Medical Center

Kingman, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

Kaiser Permanente-Franklin

Denver, Colorado, United States

Kaiser Permanente-Rock Creek

Lafayette, Colorado, United States

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, United States

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, United States

Queen's Medical Center

Honolulu, Hawaii, United States

Straub Clinic and Hospital

Honolulu, Hawaii, United States

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Queen's Cancer Center - Kuakini

Honolulu, Hawaii, United States

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Tripler Army Medical Center

Honolulu, Hawaii, United States

Hawaii Cancer Care - Westridge

‘Aiea, Hawaii, United States

Pali Momi Medical Center

‘Aiea, Hawaii, United States

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

UI Health Care Mission Cancer and Blood - Ankeny Clinic

Ankeny, Iowa, United States

Physicians' Clinic of Iowa PC

Cedar Rapids, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

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

Clive, Iowa, United States

Iowa Methodist Medical Center

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Des Moines Clinic

Des Moines, Iowa, United States

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

UI Health Care Mission Cancer and Blood - Laurel Clinic

Des Moines, Iowa, United States

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

University Medical Center New Orleans

New Orleans, Louisiana, United States

Christiana Care - Union Hospital

Elkton, Maryland, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Saint Louis Cancer and Breast Institute-Ballwin

Ballwin, Missouri, United States

Parkland Health Center - Farmington

Farmington, Missouri, United States

Mercy Hospital Joplin

Joplin, Missouri, United States

Lake Regional Hospital

Osage Beach, Missouri, United States

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, United States

Mercy Hospital Springfield

Springfield, Missouri, United States

Mercy Hospital South

St Louis, Missouri, United States

Missouri Baptist Medical Center

St Louis, Missouri, United States

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, United States

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, United States

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, United States

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Waverly Hematology Oncology

Cary, North Carolina, United States

Outer Banks Hospital

Nags Head, North Carolina, United States

Strecker Cancer Center-Belpre

Belpre, Ohio, United States

Mount Carmel East Hospital

Columbus, Ohio, United States

The Mark H Zangmeister Center

Columbus, Ohio, United States

Mount Carmel Grove City Hospital

Grove City, Ohio, United States

Marietta Memorial Hospital

Marietta, Ohio, United States

Knox Community Hospital

Mount Vernon, Ohio, United States

Licking Memorial Hospital

Newark, Ohio, United States

Saint Ann's Hospital

Westerville, Ohio, United States

Providence Newberg Medical Center

Newberg, Oregon, United States

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Providence Portland Medical Center

Portland, Oregon, United States

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, United States

Geisinger Medical Center

Danville, Pennsylvania, United States

Geisinger Medical Center-Cancer Center Hazleton

Hazleton, Pennsylvania, United States

Geisinger Medical Oncology-Lewisburg

Lewisburg, Pennsylvania, United States

Geisinger Cancer Services-Pottsville

Pottsville, Pennsylvania, United States

Community Medical Center

Scranton, Pennsylvania, United States

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Roper Hospital

Charleston, South Carolina, United States

Charleston Oncology - Roper

Charleston, South Carolina, United States

Lowcountry Hematology Oncology PA-North Charleston

Charleston, South Carolina, United States

Bon Secours Saint Francis Hospital

Charleston, South Carolina, United States

Charleston Oncology - Saint Francis

Charleston, South Carolina, United States

Lowcountry Hematology Oncology PA-West Ashley

Charleston, South Carolina, United States

Lowcountry Hematology Oncology PA-Mount Pleasant

Mt. Pleasant, South Carolina, United States

Chesapeake Regional Medical Center

Chesapeake, Virginia, United States

Hematology Oncology Associates of Fredericksburg Inc

Fredericksburg, Virginia, United States

Centra Alan B Pearson Regional Cancer Center

Lynchburg, Virginia, United States

Virginia Cancer Institute

Richmond, Virginia, United States

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

VCU Community Memorial Health Center

South Hill, Virginia, United States

Shenandoah Oncology PC

Winchester, Virginia, United States

Valley Health / Winchester Medical Center

Winchester, Virginia, United States

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Valley Medical Center

Renton, Washington, United States

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, United States

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

ThedaCare Regional Cancer Center

Appleton, Wisconsin, United States

HSHS Sacred Heart Hospital

Eau Claire, Wisconsin, United States

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Cancer Center of Western Wisconsin

New Richmond, Wisconsin, United States

Saint Vincent Hospital Cancer Center at Sturgeon Bay

Sturgeon Bay, Wisconsin, United States