RECRUITING

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

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Conditions

Hematopoietic and Lymphoid Cell NeoplasmMalignant Solid Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-24
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04829539

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Be at least 18 years of age
  2. * Be diagnosed with cancer (stage I, II, III, or IV) with a life expectancy of at least 12 months
  3. * Be currently receiving any cancer treatment (surgery alone is excluded)
  4. * 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"
  5. * Have a score of 2, 1, or 0 on the Eastern Cooperative Oncology Group (ECOG) performance status scale
  6. * Be able to speak, understand and read English to participate in the study assessments and interventions
  1. * Have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled)
  2. * Be engaged in a formal Cognitive Behavioral Therapy for Insomnia program presently or in the past 30 days. Use of psychotropics and sleep medication are allowed

Contacts and Locations

Principal Investigator

Oxana Palesh
PRINCIPAL_INVESTIGATOR
University of Rochester NCORP Research Base

Study Locations (Sites)

Kingman Regional Medical Center
Kingman, Arizona, 86401
United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, 72903
United States
Kaiser Permanente NCORP
Oakland, California, 94612
United States
Kaiser Permanente-Franklin
Denver, Colorado, 80205
United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, 80026
United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, 80124
United States
Beebe South Coastal Health Campus
Frankford, Delaware, 19945
United States
Helen F Graham Cancer Center
Newark, Delaware, 19713
United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, 19713
United States
Beebe Health Campus
Rehoboth Beach, Delaware, 19971
United States
Hawaii Cancer Care - Westridge
'Aiea, Hawaii, 96701
United States
Pali Momi Medical Center
'Aiea, Hawaii, 96701
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, 96813
United States
Hawaii Minority Underserved NCORP
Honolulu, Hawaii, 96813
United States
Queen's Cancer Center - POB I
Honolulu, Hawaii, 96813
United States
Queen's Medical Center
Honolulu, Hawaii, 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
United States
University of Hawaii Cancer Center
Honolulu, Hawaii, 96813
United States
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, 96817
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
United States
Illinois CancerCare-Bloomington
Bloomington, Illinois, 61704
United States
Illinois CancerCare-Canton
Canton, Illinois, 61520
United States
Memorial Hospital of Carbondale
Carbondale, Illinois, 62902
United States
SIH Cancer Institute
Carterville, Illinois, 62918
United States
Centralia Oncology Clinic
Centralia, Illinois, 62801
United States
Carle at The Riverfront
Danville, Illinois, 61832
United States
Heartland Cancer Research NCORP
Decatur, Illinois, 61526
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois, 62526
United States
Decatur Memorial Hospital
Decatur, Illinois, 62526
United States
Heartland Cancer Research NCORP
Decatur, Illinois, 62526
United States
Crossroads Cancer Center
Effingham, Illinois, 62401
United States
Illinois CancerCare-Galesburg
Galesburg, Illinois, 61401
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois, 62269
United States
Illinois CancerCare-Pekin
Pekin, Illinois, 61554
United States
Illinois CancerCare-Peoria
Peoria, Illinois, 61615
United States
Carle Cancer Center NCORP
Urbana, Illinois, 61801
United States
Illinois CancerCare - Washington
Washington, Illinois, 61571
United States
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa, 52402
United States
Iowa Methodist Medical Center
Des Moines, Iowa, 50309
United States
Mission Cancer and Blood - Des Moines
Des Moines, Iowa, 50309
United States
Louisiana State University Health Science Center
New Orleans, Louisiana, 70112
United States
University Medical Center New Orleans
New Orleans, Louisiana, 70112
United States
Christiana Care - Union Hospital
Elkton, Maryland, 21921
United States
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan, 49503
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota, 55337
United States
Mercy Hospital
Coon Rapids, Minnesota, 55433
United States
Fairview Southdale Hospital
Edina, Minnesota, 55435
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota, 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota, 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota, 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
United States
Metro Minnesota Community Oncology Research Consortium
Minneapolis, Minnesota, 55426
United States
Monticello Cancer Center
Monticello, Minnesota, 55362
United States
New Ulm Medical Center
New Ulm, Minnesota, 56073
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, 55416
United States
Regions Hospital
Saint Paul, Minnesota, 55101
United States
United Hospital
Saint Paul, Minnesota, 55101
United States
Saint Francis Regional Medical Center
Shakopee, Minnesota, 55379
United States
Rice Memorial Hospital
Willmar, Minnesota, 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota, 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota, 55092
United States
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri, 63011
United States
Mercy Hospital Joplin
Joplin, Missouri, 64804
United States
Mercy Hospital South
Saint Louis, Missouri, 63128
United States
Mercy Hospital Saint Louis
Saint Louis, Missouri, 63141
United States
Cancer Research for the Ozarks NCORP
Springfield, Missouri, 65804
United States
Mercy Hospital Springfield
Springfield, Missouri, 65804
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada, 89052
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada, 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada, 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada, 89074
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada, 89102
United States
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada, 89106
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada, 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada, 89128
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada, 89128
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada, 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89148
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada, 89148
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada, 89169
United States
Marietta Memorial Hospital
Marietta, Nevada, 45750
United States
Outer Banks Hospital
Nags Head, North Carolina, 27959
United States
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina, 27104
United States
Strecker Cancer Center-Belpre
Belpre, Ohio, 45714
United States
Mount Carmel East Hospital
Columbus, Ohio, 43213
United States
The Mark H Zangmeister Center
Columbus, Ohio, 43219
United States
Delaware/Christiana Care NCORP
Dayton, Ohio, 45459
United States
Mount Carmel Grove City Hospital
Grove City, Ohio, 43123
United States
Knox Community Hospital
Mount Vernon, Ohio, 43050
United States
Licking Memorial Hospital
Newark, Ohio, 43055
United States
Saint Ann's Hospital
Westerville, Ohio, 43081
United States
Providence Newberg Medical Center
Newberg, Oregon, 97132
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon, 997045
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon, 97225
United States
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania, 19317
United States
Geisinger Medical Center
Danville, Pennsylvania, 17822
United States
Geisinger Cancer Institute NCORP
Dayton, Pennsylvania, 17822
United States
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania, 18201
United States
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania, 17837
United States
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania, 17901
United States
Community Medical Center
Scranton, Pennsylvania, 18510
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania, 18711
United States
Roper Hospital
Charleston, South Carolina, 29401
United States
Charleston Oncology - Roper
Charleston, South Carolina, 29403
United States
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina, 29406
United States
Bon Secours Saint Francis Hospital
Charleston, South Carolina, 29414
United States
Charleston Oncology - Saint Francis
Charleston, South Carolina, 29414
United States
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina, 29414
United States
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant, South Carolina, 29464
United States
Chesapeake Regional Medical Center
Chesapeake, Virginia, 23320
United States
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia, 22408
United States
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia, 24501
United States
Virginia Cancer Institute
Richmond, Virginia, 23230
United States
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
United States
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
United States
VCU Community Memorial Health Center
South Hill, Virginia, 23970
United States
Shenandoah Oncology PC
Winchester, Virginia, 22601
United States
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington, 98225
United States
PeaceHealth United General Medical Center
Sedro-Woolley, Washington, 98284
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin, 54911
United States
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin, 54701
United States
Cancer Research of Wisconsin and Northern Michigan Consortium
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin, 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin, 54303
United States
Westfields Hospital/Cancer Center of Western Wisconsin
New Richmond, Wisconsin, 54017
United States

Collaborators and Investigators

Sponsor: University of Rochester NCORP Research Base

  • Oxana Palesh, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

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 Registration Dates

Study Start Date2021-06-24
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2021-06-24
Study Completion Date2027-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm