Active, not recruitingPhase 3
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Cancer Treatment
Key facts
- Where
- ‘Aiea, Ankeny, Appleton, Ballwin, Battle Creek, Bellingham, Belpre, Bloomington, Burnsville, Canton, Carbondale, Carterville, Carthage, Cary, Cedar Rapids, Centralia, Chadds Ford, Charleston, Chesapeake, Clive, Columbus, Coon Rapids, Danville, Decatur, Denver, Des Moines, Dixon, Eau Claire, Edina, Effingham, Elkton, Eureka, Farmington, Fort Smith, Fredericksburg, Fridley, Galesburg, Grand Rapids, Green Bay, Grove City, Hazleton, Henderson, Honolulu, Joplin, Kewanee, Kingman, Lafayette, Las Vegas, Lewisburg, Lone Tree, Longview, Lynchburg, Macomb, Maplewood, Marietta, Millville, Minneapolis, Monticello, Mount Vernon, Mt. Pleasant, Nags Head, New Orleans, New Richmond, New Ulm, Newark, Newberg, O'Fallon, Oregon City, Osage Beach, Ottawa, Pekin, Peoria, Peru, Portland, Pottsville, Princeton, Reed City, Rehoboth Beach, Renton, Richmond, Saint Louis Park, Saint Paul, Sainte Genevieve, Savannah, Scranton, Sedro-Woolley, Shakopee, South Hill, Springfield, St Louis, Sturgeon Bay, Sullivan, Sunset Hills, Urbana, Vancouver, Waconia, Washington, Westerville, Wilkes-Barre, Willmar, Winchester, Woodbury, and Wyoming, United StatesSee the 153 sites
- Phase
- Phase 3
Where in United States
- Hawaii Cancer Care - Westridge‘Aiea, United StatesNo longer taking part
- Pali Momi Medical Center‘Aiea, United StatesNo longer taking part
- The Cancer Center of Hawaii-Pali Momi‘Aiea, United StatesNo longer taking part
- UI Health Care Mission Cancer and Blood - Ankeny ClinicAnkeny, United StatesNo longer taking part
- ThedaCare Regional Cancer CenterAppleton, United StatesNo longer taking part
- Saint Louis Cancer and Breast Institute-BallwinBallwin, United StatesNo longer taking part
- Bronson Battle CreekBattle Creek, United StatesNo longer taking part
- PeaceHealth Saint Joseph Medical CenterBellingham, United StatesNo longer taking part
- Strecker Cancer Center-BelpreBelpre, United StatesNo longer taking part
- Illinois CancerCare-BloomingtonBloomington, United StatesNo longer taking part
- Minnesota Oncology - BurnsvilleBurnsville, United StatesNo longer taking part
- Illinois CancerCare-CantonCanton, United StatesNo longer taking part
- Memorial Hospital of CarbondaleCarbondale, United StatesNo longer taking part
- SIH Cancer InstituteCarterville, United StatesNo longer taking part
- Illinois CancerCare-CarthageCarthage, United StatesNo longer taking part
- Waverly Hematology OncologyCary, United StatesNo longer taking part
- Physicians' Clinic of Iowa PCCedar Rapids, United StatesNo longer taking part
- Centralia Oncology ClinicCentralia, United StatesNo longer taking part
- Christiana Care Health System-Concord Health CenterChadds Ford, United StatesNo longer taking part
- Bon Secours Saint Francis HospitalCharleston, United StatesNo longer taking part
- Charleston Oncology - RoperCharleston, United StatesNo longer taking part
- Charleston Oncology - Saint FrancisCharleston, United StatesNo longer taking part
- Lowcountry Hematology Oncology PA-North CharlestonCharleston, United StatesNo longer taking part
- Lowcountry Hematology Oncology PA-West AshleyCharleston, United StatesNo longer taking part
- Roper HospitalCharleston, United StatesNo longer taking part
- Chesapeake Regional Medical CenterChesapeake, United StatesNo longer taking part
- Mercy Cancer Center-West LakesClive, United StatesNo longer taking part
- UI Health Care Mission Cancer and Blood - West Des Moines ClinicClive, United StatesNo longer taking part
- Mount Carmel East HospitalColumbus, United StatesNo longer taking part
- The Mark H Zangmeister CenterColumbus, United StatesNo longer taking part
- Mercy HospitalCoon Rapids, United StatesNo longer taking part
- Carle at The RiverfrontDanville, United StatesNo longer taking part
- Geisinger Medical CenterDanville, United StatesNo longer taking part
- Cancer Care Specialists of Illinois - DecaturDecatur, United StatesNo longer taking part
- Decatur Memorial HospitalDecatur, United StatesNo longer taking part
- Kaiser Permanente-FranklinDenver, United StatesNo longer taking part
- Iowa Methodist Medical CenterDes Moines, United StatesNo longer taking part
- Mercy Medical Center - Des MoinesDes Moines, United StatesNo longer taking part
- UI Health Care Mission Cancer and Blood - Des Moines ClinicDes Moines, United StatesNo longer taking part
- UI Health Care Mission Cancer and Blood - Laurel ClinicDes Moines, United StatesNo longer taking part
- Illinois CancerCare-DixonDixon, United StatesNo longer taking part
- HSHS Sacred Heart HospitalEau Claire, United StatesNo longer taking part
- Fairview Southdale HospitalEdina, United StatesNo longer taking part
- Crossroads Cancer CenterEffingham, United StatesNo longer taking part
- Christiana Care - Union HospitalElkton, United StatesNo longer taking part
- Illinois CancerCare-EurekaEureka, United StatesNo longer taking part
- Parkland Health Center - FarmingtonFarmington, United StatesNo longer taking part
- Mercy Hospital Fort SmithFort Smith, United StatesNo longer taking part
- Hematology Oncology Associates of Fredericksburg IncFredericksburg, United StatesNo longer taking part
- Unity HospitalFridley, United StatesNo longer taking part
- Illinois CancerCare-GalesburgGalesburg, United StatesNo longer taking part
- Corewell Health Grand Rapids Hospitals - Butterworth HospitalGrand Rapids, United StatesNo longer taking part
- Trinity Health Grand Rapids HospitalGrand Rapids, United StatesNo longer taking part
- Saint Vincent Hospital Cancer Center at Saint Mary'sGreen Bay, United StatesNo longer taking part
- Saint Vincent Hospital Cancer Center Green BayGreen Bay, United StatesNo longer taking part
- Mount Carmel Grove City HospitalGrove City, United StatesNo longer taking part
- Geisinger Medical Center-Cancer Center HazletonHazleton, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - HendersonHenderson, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada-Southeast HendersonHenderson, United StatesNo longer taking part
- OptumCare Cancer Care at Seven HillsHenderson, United StatesNo longer taking part
- Urology Specialists of Nevada - Green ValleyHenderson, United StatesNo longer taking part
- Hawaii Cancer Care Inc - Waterfront PlazaHonolulu, United StatesNo longer taking part
- Kapiolani Medical Center for Women and ChildrenHonolulu, United StatesNo longer taking part
- Queen's Cancer Cenrer - POB IHonolulu, United StatesNo longer taking part
- Queen's Cancer Center - KuakiniHonolulu, United StatesNo longer taking part
- Queen's Medical CenterHonolulu, United StatesNo longer taking part
- Straub Clinic and HospitalHonolulu, United StatesNo longer taking part
- The Cancer Center of Hawaii-LilihaHonolulu, United StatesNo longer taking part
- Tripler Army Medical CenterHonolulu, United StatesNo longer taking part
- University of Hawaii Cancer CenterHonolulu, United StatesNo longer taking part
- Mercy Hospital JoplinJoplin, United StatesNo longer taking part
- Illinois CancerCare-Kewanee ClinicKewanee, United StatesNo longer taking part
- Kingman Regional Medical CenterKingman, United StatesNo longer taking part
- Kaiser Permanente-Rock CreekLafayette, United StatesNo longer taking part
- Alliance for Childhood Diseases/Cure 4 the Kids FoundationLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of NevadaLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - Central ValleyLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - NorthwestLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada - Town CenterLas Vegas, United StatesNo longer taking part
- Comprehensive Cancer Centers of Nevada-SummerlinLas Vegas, United StatesNo longer taking part
- OptumCare Cancer Care at CharlestonLas Vegas, United StatesNo longer taking part
- OptumCare Cancer Care at Fort ApacheLas Vegas, United StatesNo longer taking part
- OptumCare Cancer Care at MountainViewLas Vegas, United StatesNo longer taking part
- Summerlin Hospital Medical CenterLas Vegas, United StatesNo longer taking part
- Urology Specialists of Nevada - NorthwestLas Vegas, United StatesNo longer taking part
- Urology Specialists of Nevada - SouthwestLas Vegas, United StatesNo longer taking part
- Geisinger Medical Oncology-LewisburgLewisburg, United StatesNo longer taking part
- Kaiser Permanente-Lone TreeLone Tree, United StatesNo longer taking part
- PeaceHealth Saint John Medical CenterLongview, United StatesNo longer taking part
- Centra Alan B Pearson Regional Cancer CenterLynchburg, United StatesNo longer taking part
- Illinois CancerCare-MacombMacomb, United StatesNo longer taking part
- Minnesota Oncology Hematology PA-MaplewoodMaplewood, United StatesNo longer taking part
- Saint John's Hospital - HealtheastMaplewood, United StatesNo longer taking part
- Marietta Memorial HospitalMarietta, United StatesNo longer taking part
- Beebe South Coastal Health CampusMillville, United StatesNo longer taking part
- Abbott-Northwestern HospitalMinneapolis, United StatesNo longer taking part
- Hennepin County Medical CenterMinneapolis, United StatesNo longer taking part
- Monticello Cancer CenterMonticello, United StatesNo longer taking part
- Knox Community HospitalMount Vernon, United StatesNo longer taking part
- Lowcountry Hematology Oncology PA-Mount PleasantMt. Pleasant, United StatesNo longer taking part
- Outer Banks HospitalNags Head, United StatesNo longer taking part
- Louisiana State University Health Science CenterNew Orleans, United StatesNo longer taking part
- University Medical Center New OrleansNew Orleans, United StatesNo longer taking part
- Cancer Center of Western WisconsinNew Richmond, United StatesNo longer taking part
- New Ulm Medical CenterNew Ulm, United StatesNo longer taking part
- Helen F Graham Cancer CenterNewark, United StatesNo longer taking part
- Licking Memorial HospitalNewark, United StatesNo longer taking part
- Medical Oncology Hematology Consultants PANewark, United StatesNo longer taking part
- Providence Newberg Medical CenterNewberg, United StatesNo longer taking part
- Cancer Care Center of O'FallonO'Fallon, United StatesNo longer taking part
- Providence Willamette Falls Medical CenterOregon City, United StatesNo longer taking part
- Lake Regional HospitalOsage Beach, United StatesNo longer taking part
- Illinois CancerCare-Ottawa ClinicOttawa, United StatesNo longer taking part
- Illinois CancerCare-PekinPekin, United StatesNo longer taking part
- Illinois CancerCare-PeoriaPeoria, United StatesNo longer taking part
- Illinois CancerCare-PeruPeru, United StatesNo longer taking part
- Providence Portland Medical CenterPortland, United StatesNo longer taking part
- Providence Saint Vincent Medical CenterPortland, United StatesNo longer taking part
- Geisinger Cancer Services-PottsvillePottsville, United StatesNo longer taking part
- Illinois CancerCare-PrincetonPrinceton, United StatesNo longer taking part
- Corewell Health Reed City HospitalReed City, United StatesNo longer taking part
- Beebe Health CampusRehoboth Beach, United StatesNo longer taking part
- Valley Medical CenterRenton, United StatesNo longer taking part
- VCU Massey Cancer Center at Stony PointRichmond, United StatesNo longer taking part
- Virginia Cancer InstituteRichmond, United StatesNo longer taking part
- Virginia Commonwealth University/Massey Cancer CenterRichmond, United StatesNo longer taking part
- Park Nicollet Clinic - Saint Louis ParkSaint Louis Park, United StatesNo longer taking part
- Regions HospitalSaint Paul, United StatesNo longer taking part
- United HospitalSaint Paul, United StatesNo longer taking part
- Sainte Genevieve County Memorial HospitalSainte Genevieve, United StatesNo longer taking part
- Memorial Health University Medical CenterSavannah, United StatesNo longer taking part
- Community Medical CenterScranton, United StatesNo longer taking part
- PeaceHealth United General Medical CenterSedro-Woolley, United StatesNo longer taking part
- Saint Francis Regional Medical CenterShakopee, United StatesNo longer taking part
- VCU Community Memorial Health CenterSouth Hill, United StatesNo longer taking part
- Mercy Hospital SpringfieldSpringfield, United StatesNo longer taking part
- Mercy Hospital Saint LouisSt Louis, United StatesNo longer taking part
- Mercy Hospital SouthSt Louis, United StatesNo longer taking part
- Missouri Baptist Medical CenterSt Louis, United StatesNo longer taking part
- Saint Vincent Hospital Cancer Center at Sturgeon BaySturgeon Bay, United StatesNo longer taking part
- Missouri Baptist Sullivan HospitalSullivan, United StatesNo longer taking part
- BJC Outpatient Center at Sunset HillsSunset Hills, United StatesNo longer taking part
- Carle Cancer CenterUrbana, United StatesNo longer taking part
- PeaceHealth Southwest Medical CenterVancouver, United StatesNo longer taking part
- Ridgeview Medical CenterWaconia, United StatesNo longer taking part
- Illinois CancerCare - WashingtonWashington, United StatesNo longer taking part
- Saint Ann's HospitalWesterville, United StatesNo longer taking part
- Geisinger Wyoming Valley/Henry Cancer CenterWilkes-Barre, United StatesNo longer taking part
- Rice Memorial HospitalWillmar, United StatesNo longer taking part
- Shenandoah Oncology PCWinchester, United StatesNo longer taking part
- Valley Health / Winchester Medical CenterWinchester, United StatesNo longer taking part
- Minnesota Oncology Hematology PA-WoodburyWoodbury, United StatesNo longer taking part
- Fairview Lakes Medical CenterWyoming, United StatesNo longer taking part
Trial details
- Who runs it
- University of Rochester NCORP Research Base
- Trial code
- NCT04829539
- Record updated
- 24 April 2026
- Original description
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.Read full original descriptionShow less
Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
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.
Inclusion: 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.
Exclusion: Be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. Use of sleep medications are allowed; Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled).