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

April 22, 2026 updated by: Karen Mustian, University of Rochester NCORP Research Base

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index (ISI) at post-intervention.

SECONDARY OBJECTIVE:

I. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at post-intervention.

MECHANISTIC OBJECTIVE:

I. Examine the efficacy of BBT-CI compared to HEAL for regulating circadian rhythms as measured via actigraphy (i.e., Mesor, Acrophase, Amplitude, I<O dichotomy index).

EXPLORATORY OBJECTIVES:

I. Examine potential moderators of BBT-CI effects on insomnia (ISI). II. Examine potential mediators of BBT-CI effects on insomnia (ISI). III. Determine the efficacy of BBT-CI compared to HEAL for treating insomnia as measured by the Insomnia Severity Index at the 6-month follow-up.

IV. Determine the efficacy of BBT-CI compared to HEAL for improving sleep efficiency as measured via actigraphy at the 6-month follow-up.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (BBT-CI): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

GROUP II (HEAL): Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

After completion of study, patients are followed for up to 6 months.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, United States, 72903
        • Mercy Hospital Fort Smith
    • Colorado
      • Denver, Colorado, United States, 80205
        • Kaiser Permanente-Franklin
      • Lafayette, Colorado, United States, 80026
        • Kaiser Permanente-Rock Creek
      • Lone Tree, Colorado, United States, 80124
        • Kaiser Permanente-Lone Tree
    • Delaware
      • Millville, Delaware, United States, 19967
        • Beebe South Coastal Health Campus
      • Newark, Delaware, United States, 19713
        • Helen F Graham Cancer Center
      • Newark, Delaware, United States, 19713
        • Medical Oncology Hematology Consultants PA
      • Rehoboth Beach, Delaware, United States, 19971
        • Beebe Health Campus
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Memorial Health University Medical Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queen's Medical Center
      • Honolulu, Hawaii, United States, 96817
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, United States, 96813
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic and Hospital
      • Honolulu, Hawaii, United States, 96813
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, United States, 96817
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center for Women and Children
      • Honolulu, Hawaii, United States, 96859
        • Tripler Army Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • Hawaii Cancer Care - Westridge
      • ‘Aiea, Hawaii, United States, 96701
        • Pali Momi Medical Center
      • ‘Aiea, Hawaii, United States, 96701
        • The Cancer Center of Hawaii-Pali Momi
    • Illinois
      • Bloomington, Illinois, United States, 61704
        • Illinois CancerCare-Bloomington
      • Canton, Illinois, United States, 61520
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, United States, 62902
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, United States, 62918
        • SIH Cancer Institute
      • Carthage, Illinois, United States, 62321
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, United States, 62801
        • Centralia Oncology Clinic
      • Danville, Illinois, United States, 61832
        • Carle at The Riverfront
      • Decatur, Illinois, United States, 62526
        • Decatur Memorial Hospital
      • Decatur, Illinois, United States, 62526
        • Cancer Care Specialists of Illinois - Decatur
      • Dixon, Illinois, United States, 61021
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, United States, 62401
        • Crossroads Cancer Center
      • Eureka, Illinois, United States, 61530
        • Illinois CancerCare-Eureka
      • Galesburg, Illinois, United States, 61401
        • Illinois CancerCare-Galesburg
      • Kewanee, Illinois, United States, 61443
        • Illinois CancerCare-Kewanee Clinic
      • Macomb, Illinois, United States, 61455
        • Illinois CancerCare-Macomb
      • O'Fallon, Illinois, United States, 62269
        • Cancer Care Center of O'Fallon
      • Ottawa, Illinois, United States, 61350
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, United States, 61554
        • Illinois CancerCare-Pekin
      • Peoria, Illinois, United States, 61615
        • Illinois CancerCare-Peoria
      • Peru, Illinois, United States, 61354
        • Illinois CancerCare-Peru
      • Princeton, Illinois, United States, 61356
        • Illinois CancerCare-Princeton
      • Urbana, Illinois, United States, 61801
        • Carle Cancer Center
      • Washington, Illinois, United States, 61571
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, United States, 50023
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
      • Cedar Rapids, Iowa, United States, 52402
        • Physicians' Clinic of Iowa PC
      • Clive, Iowa, United States, 50325
        • Mercy Cancer Center-West Lakes
      • Clive, Iowa, United States, 50325
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
      • Des Moines, Iowa, United States, 50309
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, United States, 50314
        • Mercy Medical Center - Des Moines
      • Des Moines, Iowa, United States, 50309
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Des Moines, Iowa, United States, 50314
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • University Medical Center New Orleans
      • New Orleans, Louisiana, United States, 70112
        • Louisiana State University Health Science Center
    • Maryland
      • Elkton, Maryland, United States, 21921
        • Christiana Care - Union Hospital
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Bronson Battle Creek
      • Grand Rapids, Michigan, United States, 49503
        • Trinity Health Grand Rapids Hospital
      • Grand Rapids, Michigan, United States, 49503
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
      • Reed City, Michigan, United States, 49677
        • Corewell Health Reed City Hospital
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Minnesota Oncology - Burnsville
      • Coon Rapids, Minnesota, United States, 55433
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Unity Hospital
      • Maplewood, Minnesota, United States, 55109
        • Saint John's Hospital - Healtheast
      • Maplewood, Minnesota, United States, 55109
        • Minnesota Oncology Hematology PA-Maplewood
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Abbott-Northwestern Hospital
      • Monticello, Minnesota, United States, 55362
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • New Ulm Medical Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Saint Francis Regional Medical Center
      • Waconia, Minnesota, United States, 55387
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, United States, 63011
        • Saint Louis Cancer and Breast Institute-Ballwin
      • Farmington, Missouri, United States, 63640
        • Parkland Health Center - Farmington
      • Joplin, Missouri, United States, 64804
        • Mercy Hospital Joplin
      • Osage Beach, Missouri, United States, 65065
        • Lake Regional Hospital
      • Sainte Genevieve, Missouri, United States, 63670
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, United States, 65804
        • Mercy Hospital Springfield
      • St Louis, Missouri, United States, 63131
        • Missouri Baptist Medical Center
      • St Louis, Missouri, United States, 63141
        • Mercy Hospital Saint Louis
      • St Louis, Missouri, United States, 63128
        • Mercy Hospital South
      • Sullivan, Missouri, United States, 63080
        • Missouri Baptist Sullivan Hospital
      • Sunset Hills, Missouri, United States, 63127
        • BJC Outpatient Center at Sunset Hills
    • Nevada
      • Henderson, Nevada, United States, 89052
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, United States, 89052
        • OptumCare Cancer Care at Seven Hills
      • Henderson, Nevada, United States, 89074
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, United States, 89074
        • Urology Specialists of Nevada - Green Valley
      • Las Vegas, Nevada, United States, 89144
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, United States, 89102
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, United States, 89128
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89128
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, United States, 89135
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, United States, 89144
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, United States, 89148
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, United States, 89148
        • OptumCare Cancer Care at Fort Apache
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, United States, 89128
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, United States, 89113
        • Urology Specialists of Nevada - Southwest
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Waverly Hematology Oncology
      • Nags Head, North Carolina, United States, 27959
        • Outer Banks Hospital
    • Ohio
      • Belpre, Ohio, United States, 45714
        • Strecker Cancer Center-Belpre
      • Columbus, Ohio, United States, 43219
        • The Mark H Zangmeister Center
      • Columbus, Ohio, United States, 43213
        • Mount Carmel East Hospital
      • Grove City, Ohio, United States, 43123
        • Mount Carmel Grove City Hospital
      • Marietta, Ohio, United States, 45750
        • Marietta Memorial Hospital
      • Mount Vernon, Ohio, United States, 43050
        • Knox Community Hospital
      • Newark, Ohio, United States, 43055
        • Licking Memorial Hospital
      • Westerville, Ohio, United States, 43081
        • Saint Ann's Hospital
    • Oregon
      • Newberg, Oregon, United States, 97132
        • Providence Newberg Medical Center
      • Oregon City, Oregon, United States, 97045
        • Providence Willamette Falls Medical Center
      • Portland, Oregon, United States, 97213
        • Providence Portland Medical Center
      • Portland, Oregon, United States, 97225
        • Providence Saint Vincent Medical Center
    • Pennsylvania
      • Chadds Ford, Pennsylvania, United States, 19317
        • Christiana Care Health System-Concord Health Center
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Medical Center
      • Hazleton, Pennsylvania, United States, 18201
        • Geisinger Medical Center-Cancer Center Hazleton
      • Lewisburg, Pennsylvania, United States, 17837
        • Geisinger Medical Oncology-Lewisburg
      • Pottsville, Pennsylvania, United States, 17901
        • Geisinger Cancer Services-Pottsville
      • Scranton, Pennsylvania, United States, 18510
        • Community Medical Center
      • Wilkes-Barre, Pennsylvania, United States, 18711
        • Geisinger Wyoming Valley/Henry Cancer Center
    • South Carolina
      • Charleston, South Carolina, United States, 29401
        • Roper Hospital
      • Charleston, South Carolina, United States, 29406
        • Lowcountry Hematology Oncology PA-North Charleston
      • Charleston, South Carolina, United States, 29414
        • Bon Secours Saint Francis Hospital
      • Charleston, South Carolina, United States, 29414
        • Lowcountry Hematology Oncology PA-West Ashley
      • Charleston, South Carolina, United States, 29403
        • Charleston Oncology - Roper
      • Charleston, South Carolina, United States, 29414
        • Charleston Oncology - Saint Francis
      • Mt. Pleasant, South Carolina, United States, 29464
        • Lowcountry Hematology Oncology PA-Mount Pleasant
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Chesapeake Regional Medical Center
      • Fredericksburg, Virginia, United States, 22408
        • Hematology Oncology Associates of Fredericksburg Inc
      • Lynchburg, Virginia, United States, 24501
        • Centra Alan B Pearson Regional Cancer Center
      • Richmond, Virginia, United States, 23235
        • VCU Massey Cancer Center at Stony Point
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University/Massey Cancer Center
      • Richmond, Virginia, United States, 23229
        • Virginia Cancer Institute
      • South Hill, Virginia, United States, 23970
        • VCU Community Memorial Health Center
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology PC
      • Winchester, Virginia, United States, 22601
        • Valley Health / Winchester Medical Center
    • Washington
      • Bellingham, Washington, United States, 98225
        • PeaceHealth Saint Joseph Medical Center
      • Longview, Washington, United States, 98632
        • PeaceHealth Saint John Medical Center
      • Renton, Washington, United States, 98055
        • Valley Medical Center
      • Sedro-Woolley, Washington, United States, 98284
        • PeaceHealth United General Medical Center
      • Vancouver, Washington, United States, 98664
        • PeaceHealth Southwest Medical Center
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • ThedaCare Regional Cancer Center
      • Eau Claire, Wisconsin, United States, 54701
        • HSHS Sacred Heart Hospital
      • Green Bay, Wisconsin, United States, 54301
        • Saint Vincent Hospital Cancer Center Green Bay
      • Green Bay, Wisconsin, United States, 54303
        • Saint Vincent Hospital Cancer Center at Saint Mary's
      • New Richmond, Wisconsin, United States, 54017
        • Cancer Center of Western Wisconsin
      • Sturgeon Bay, Wisconsin, United States, 54235-1495
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
  • Be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. Use of sleep medications are allowed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (BBT-CI)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Behavioral: Behavioral Intervention
Receive BBT-CI
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Behavioral: Behavioral Intervention
Receive HEAL
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Other: Electronic Health Record Review
Ancillary studies
Active Comparator: Group II (HEAL)
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Other: Questionnaire Administration
Ancillary studies
Behavioral: Behavioral Intervention
Receive BBT-CI
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Behavioral: Behavioral Intervention
Receive HEAL
Other Names:
  • Behavior Conditioning Therapy
  • Behavior Modification
  • Behavior or Life Style Modifications
  • Behavior Therapy
  • Behavioral Interventions
  • Behavioral Modification
  • Behavioral Therapy
  • Behavioral Treatment
  • Behavioral Treatments
Other: Electronic Health Record Review
Ancillary studies

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI)
Time Frame: post intervention
Will evaluate the mean between arm difference in ISI score change from time point baseline to post-intervention. To assess this, will use analysis of covariance model with ISI at post-intervention as the outcome, study arm (group) as a fixed effect and baseline ISI as a covariate. Will test baseline group interaction.
post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep efficiency
Time Frame: post intervention
Will be measured via actigraphy.
post intervention
Circadian phenomena
Time Frame: Up to 6 months post intervention
Circadian phenomena will be measured via actigraphy (Mesor, Acrophase, Amplitude, I < O dichotomy index).
Up to 6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rochester NCORP Research Base

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Oxana Palesh, PhD, Massey Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2021

Primary Completion (Estimated)

October 14, 2026

Study Completion (Estimated)

April 12, 2027

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

April 1, 2021

First Posted (Actual)

April 2, 2021

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • URCC-19185 (Other Identifier: CTEP)
  • URCC19185 (Other Identifier: University of Rochester NCORP Research Base)
  • NCI-2020-07175 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • R01CA214647 (U.S. NIH Grant/Contract)
  • UG1CA189961 (U.S. NIH Grant/Contract)
  • R01CA239714 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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