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

Last updated: August 12, 2024
Sponsor: University of Rochester NCORP Research Base
Overall Status: Active - Recruiting

Phase

3

Condition

Neoplasms

Treatment

Behavioral Intervention

Quality-of-Life Assessment

Questionnaire Administration

Clinical Study ID

NCT04829539
URCC19185
URCC19185
URCC-19185
UG1CA189961
R01CA214647
NCI-2020-07175
R01CA239714
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Be at least 18 years of age

  • Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of atleast 12 months

  • Be currently receiving any cancer treatment (surgery alone is excluded)

  • Report sleep disturbance of 3 or greater on the sleep disturbance question: "Rateyour sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problemsand 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 studyassessments and interventions

Exclusion

Exclusion Criteria:

  • Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (evenif controlled)

  • Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presentlyor in the past 30 days. Use of psychotropics and sleep medication are allowed

Study Design

Total Participants: 400
Treatment Group(s): 3
Primary Treatment: Behavioral Intervention
Phase: 3
Study Start date:
June 24, 2021
Estimated Completion Date:
June 30, 2027

Study 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 OBJECTIVES:

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.

Connect with a study center

  • Nevada Cancer Research Foundation NCORP

    Las Vegas, Nevada 89106
    United States

    Active - Recruiting

    1.44 miles

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada 89102
    United States

    Active - Recruiting

    3.19 miles

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada 89169
    United States

    Active - Recruiting

    3.31 miles

  • Urology Specialists of Nevada - Northwest

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

    7.15 miles

  • OptumCare Cancer Care at MountainView

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

    7.15 miles

  • Urology Specialists of Nevada - Southwest

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

    7.15 miles

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada 89128
    United States

    Active - Recruiting

    7.15 miles

  • Urology Specialists of Nevada - Green Valley

    Henderson, Nevada 89074
    United States

    Active - Recruiting

    9.92 miles

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada 89074
    United States

    Active - Recruiting

    9.92 miles

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

    10.01 miles

  • Summerlin Hospital Medical Center

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

    10.01 miles

  • Comprehensive Cancer Centers of Nevada - Town Center

    Las Vegas, Nevada 89144
    United States

    Active - Recruiting

    10.01 miles

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

    11.52 miles

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

    11.52 miles

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada 89052
    United States

    Active - Recruiting

    13.39 miles

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada 89052
    United States

    Active - Recruiting

    13.39 miles

  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation

    Las Vegas, Nevada 89135
    United States

    Active - Recruiting

    13.97 miles

  • Kingman Regional Medical Center

    Kingman, Arizona 86401
    United States

    Active - Recruiting

    108.99 miles

  • Kaiser Permanente NCORP

    Oakland, California 94612
    United States

    Active - Recruiting

    409.06 miles

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado 80124
    United States

    Active - Recruiting

    604.89 miles

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado 80026
    United States

    Active - Recruiting

    606.55 miles

  • Kaiser Permanente-Franklin

    Denver, Colorado 80205
    United States

    Active - Recruiting

    606.7 miles

  • Providence Newberg Medical Center

    Newberg, Oregon 97132
    United States

    Active - Recruiting

    753.13 miles

  • Providence Portland Medical Center

    Portland, Oregon 97213
    United States

    Active - Recruiting

    754.64 miles

  • Providence Saint Vincent Medical Center

    Portland, Oregon 97225
    United States

    Active - Recruiting

    757.2 miles

  • PeaceHealth United General Medical Center

    Sedro-Woolley, Washington 98284
    United States

    Active - Recruiting

    925.58 miles

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington 98225
    United States

    Active - Recruiting

    945.78 miles

  • Mercy Hospital Joplin

    Joplin, Missouri 64804
    United States

    Active - Recruiting

    1,143.52 miles

  • Mercy Hospital Fort Smith

    Fort Smith, Arkansas 72903
    United States

    Active - Recruiting

    1,164.12 miles

  • Mercy Hospital Springfield

    Springfield, Missouri 65804
    United States

    Active - Recruiting

    1,212.24 miles

  • Cancer Research for the Ozarks NCORP

    Springfield, Missouri 65804
    United States

    Active - Recruiting

    1,212.24 miles

  • Mission Cancer and Blood - Des Moines

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

    1,212.51 miles

  • Iowa Methodist Medical Center

    Des Moines, Iowa 50309
    United States

    Active - Recruiting

    1,212.51 miles

  • Rice Memorial Hospital

    Willmar, Minnesota 56201
    United States

    Active - Recruiting

    1,216.09 miles

  • New Ulm Medical Center

    New Ulm, Minnesota 56073
    United States

    Active - Recruiting

    1,221.79 miles

  • Monticello Cancer Center

    Monticello, Minnesota 55362
    United States

    Active - Recruiting

    1,275.57 miles

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota 55379
    United States

    Active - Recruiting

    1,276.45 miles

  • Metro-Minnesota Ncorp

    Minneapolis, Minnesota 55426
    United States

    Active - Recruiting

    1,287.52 miles

  • Metro Minnesota Community Oncology Research Consortium

    Minneapolis, Minnesota 55426
    United States

    Active - Recruiting

    1,287.52 miles

  • Fairview Southdale Hospital

    Edina, Minnesota 55435
    United States

    Active - Recruiting

    1,287.67 miles

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota 55337
    United States

    Active - Recruiting

    1,288.13 miles

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota 55416
    United States

    Active - Recruiting

    1,289.18 miles

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota 55407
    United States

    Active - Recruiting

    1,292.91 miles

  • Hennepin County Medical Center

    Minneapolis, Minnesota 55415
    United States

    Active - Recruiting

    1,293.63 miles

  • Mercy Hospital

    Coon Rapids, Minnesota 55433
    United States

    Active - Recruiting

    1,295.51 miles

  • Regions Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

    1,300.88 miles

  • United Hospital

    Saint Paul, Minnesota 55101
    United States

    Active - Recruiting

    1,300.88 miles

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

    1,305.19 miles

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota 55109
    United States

    Active - Recruiting

    1,305.19 miles

  • Minnesota Oncology Hematology PA-Woodbury

    Woodbury, Minnesota 55125
    United States

    Active - Recruiting

    1,306.74 miles

  • Fairview Lakes Medical Center

    Wyoming, Minnesota 55092
    United States

    Active - Recruiting

    1,310.95 miles

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa 52402
    United States

    Active - Recruiting

    1,317.35 miles

  • Westfields Hospital/Cancer Center of Western Wisconsin

    New Richmond, Wisconsin 54017
    United States

    Active - Recruiting

    1,330.84 miles

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri 63011
    United States

    Active - Recruiting

    1,355.72 miles

  • Mercy Hospital Saint Louis

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

    1,361.05 miles

  • Mercy Hospital South

    Saint Louis, Missouri 63128
    United States

    Active - Recruiting

    1,365.3 miles

  • HSHS Sacred Heart Hospital

    Eau Claire, Wisconsin 54701
    United States

    Active - Recruiting

    1,369.48 miles

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois 61401
    United States

    Active - Recruiting

    1,372.22 miles

  • Illinois CancerCare-Canton

    Canton, Illinois 61520
    United States

    Active - Recruiting

    1,388.88 miles

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois 62269
    United States

    Active - Recruiting

    1,390.57 miles

  • Illinois CancerCare-Pekin

    Pekin, Illinois 61554
    United States

    Active - Recruiting

    1,409.82 miles

  • Illinois CancerCare-Peoria

    Peoria, Illinois 61615
    United States

    Active - Recruiting

    1,410.6 miles

  • Heartland Cancer Research NCORP

    Decatur, Illinois 61526
    United States

    Active - Recruiting

    1,411.75 miles

  • Illinois CancerCare - Washington

    Washington, Illinois 61571
    United States

    Active - Recruiting

    1,421.04 miles

  • Centralia Oncology Clinic

    Centralia, Illinois 62801
    United States

    Active - Recruiting

    1,432.4 miles

  • Memorial Hospital of Carbondale

    Carbondale, Illinois 62902
    United States

    Active - Recruiting

    1,436.59 miles

  • SIH Cancer Institute

    Carterville, Illinois 62918
    United States

    Active - Recruiting

    1,437.64 miles

  • Heartland NCORP

    Decatur, Illinois 62526
    United States

    Active - Recruiting

    1,440.75 miles

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois 62526
    United States

    Active - Recruiting

    1,440.75 miles

  • Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Active - Recruiting

    1,440.75 miles

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois 61704
    United States

    Active - Recruiting

    1,445.07 miles

  • Crossroads Cancer Center

    Effingham, Illinois 62401
    United States

    Active - Recruiting

    1,462.7 miles

  • Carle Cancer Center NCORP

    Urbana, Illinois 61801
    United States

    Active - Recruiting

    1,482.4 miles

  • Louisiana State University Health Science Center

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

    1,508.48 miles

  • University Medical Center New Orleans

    New Orleans, Louisiana 70112
    United States

    Active - Recruiting

    1,508.48 miles

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin 54911
    United States

    Active - Recruiting

    1,510.18 miles

  • Carle at The Riverfront

    Danville, Illinois 61832
    United States

    Active - Recruiting

    1,513.04 miles

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin 54303
    United States

    Active - Recruiting

    1,529.96 miles

  • Cancer Research of Wisconsin and Northern Michigan Consortium

    Green Bay, Wisconsin 54301
    United States

    Active - Recruiting

    1,530.57 miles

  • Saint Vincent Hospital

    Green Bay, Wisconsin 54301
    United States

    Active - Recruiting

    1,530.57 miles

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin 54301
    United States

    Active - Recruiting

    1,530.57 miles

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan 49503
    United States

    Active - Recruiting

    1,629.24 miles

  • Delaware/Christiana Care NCORP

    Dayton, Ohio 45459
    United States

    Active - Recruiting

    1,696.81 miles

  • Mount Carmel Grove City Hospital

    Grove City, Ohio 43123
    United States

    Active - Recruiting

    1,751.85 miles

  • The Mark H Zangmeister Center

    Columbus, Ohio 43219
    United States

    Active - Recruiting

    1,762.06 miles

  • Saint Ann's Hospital

    Westerville, Ohio 43081
    United States

    Active - Recruiting

    1,763.52 miles

  • Mount Carmel East Hospital

    Columbus, Ohio 43213
    United States

    Active - Recruiting

    1,765.04 miles

  • Knox Community Hospital

    Mount Vernon, Ohio 43050
    United States

    Active - Recruiting

    1,783.94 miles

  • Licking Memorial Hospital

    Newark, Ohio 43055
    United States

    Active - Recruiting

    1,790.66 miles

  • Strecker Cancer Center-Belpre

    Belpre, Ohio 45714
    United States

    Active - Recruiting

    1,833.58 miles

  • Marietta Memorial Hospital

    Marietta, Nevada 45750
    United States

    Active - Recruiting

    1,843.22 miles

  • Southeast Clinical Oncology Research Consortium

    Winston-Salem, North Carolina 27104
    United States

    Active - Recruiting

    1,932.07 miles

  • Centra Lynchburg Hematology-Oncology Clinic Inc

    Lynchburg, Virginia 24501
    United States

    Active - Recruiting

    1,981.25 miles

  • Bon Secours Saint Francis Hospital

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

    1,996.89 miles

  • Lowcountry Hematology Oncology PA-West Ashley

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

    1,996.89 miles

  • Charleston Oncology - Saint Francis

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

    1,996.89 miles

  • Lowcountry Hematology Oncology PA-North Charleston

    Charleston, South Carolina 29406
    United States

    Active - Recruiting

    1,999.41 miles

  • Charleston Oncology - Roper

    Charleston, South Carolina 29403
    United States

    Active - Recruiting

    2,006.71 miles

  • Roper Hospital

    Charleston, South Carolina 29401
    United States

    Active - Recruiting

    2,007.77 miles

  • Lowcountry Hematology Oncology PA-Mount Pleasant

    Mount Pleasant, South Carolina 29464
    United States

    Active - Recruiting

    2,011.37 miles

  • Shenandoah Oncology PC

    Winchester, Virginia 22601
    United States

    Active - Recruiting

    2,018.11 miles

  • University of Rochester NCORP Research Base

    Rochester, New York 14642
    United States

    Site Not Available

    2,034.58 miles

  • VCU Community Memorial Health Center

    South Hill, Virginia 23970
    United States

    Active - Recruiting

    2,040.88 miles

  • Hematology Oncology Associates of Fredericksburg Inc

    Fredericksburg, Virginia 22408
    United States

    Active - Recruiting

    2,065.34 miles

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia 23235
    United States

    Active - Recruiting

    2,065.84 miles

  • Virginia Cancer Institute

    Richmond, Virginia 23230
    United States

    Active - Recruiting

    2,068.98 miles

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Active - Recruiting

    2,072.82 miles

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania 17837
    United States

    Active - Recruiting

    2,072.97 miles

  • Geisinger Cancer Institute NCORP

    Dayton, Pennsylvania 17822
    United States

    Active - Recruiting

    2,090.64 miles

  • Geisinger Medical Center

    Danville, Pennsylvania 17822
    United States

    Active - Recruiting

    2,090.64 miles

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania 17901
    United States

    Active - Recruiting

    2,110.12 miles

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania 18201
    United States

    Active - Recruiting

    2,124.54 miles

  • Christiana Care - Union Hospital

    Elkton, Maryland 21921
    United States

    Active - Recruiting

    2,137.72 miles

  • Community Medical Center

    Scranton, Pennsylvania 18510
    United States

    Active - Recruiting

    2,138.6 miles

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware 19713
    United States

    Active - Recruiting

    2,145.28 miles

  • Helen F Graham Cancer Center

    Newark, Delaware 19713
    United States

    Active - Recruiting

    2,145.28 miles

  • Chesapeake Regional Medical Center

    Chesapeake, Virginia 23320
    United States

    Active - Recruiting

    2,147.97 miles

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania 19317
    United States

    Active - Recruiting

    2,149.57 miles

  • Beebe South Coastal Health Campus

    Frankford, Delaware 19945
    United States

    Active - Recruiting

    2,181.16 miles

  • Beebe Health Campus

    Rehoboth Beach, Delaware 19971
    United States

    Active - Recruiting

    2,186.1 miles

  • Outer Banks Hospital

    Nags Head, North Carolina 27959
    United States

    Active - Recruiting

    2,193.94 miles

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii 96817
    United States

    Active - Recruiting

    2,755.33 miles

  • Hawaii Cancer Care - Westridge

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

    2,756.41 miles

  • Pali Momi Medical Center

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

    2,756.41 miles

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii 96826
    United States

    Active - Recruiting

    2,756.5 miles

  • Queen's Medical Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • Queen's Cancer Center - POB I

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • Straub Clinic and Hospital

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • Hawaii Minority Underserved NCORP

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • University of Hawaii Cancer Center

    Honolulu, Hawaii 96813
    United States

    Active - Recruiting

    2,756.52 miles

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon 997045
    United States

    Active - Recruiting

  • Geisinger Wyoming Valley/Henry Cancer Center

    Wilkes-Barre, Pennsylvania 18711
    United States

    Active - Recruiting

  • Michigan Cancer Research Consortium

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.