Spots Global Cancer Trial Database for Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
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Trial Identification
Brief Title: Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
Official Title: Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
Study ID: NCT04829539
Study Description
Brief 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.
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 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Kingman Regional Medical Center, Kingman, Arizona, United States
Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States
Kaiser Permanente NCORP, Oakland, California, 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, Frankford, 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
Hawaii Cancer Care - Westridge, 'Aiea, Hawaii, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Hawaii Minority Underserved NCORP, Honolulu, Hawaii, United States
Queen's Cancer Center - 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
Kapiolani Medical Center for Women and Children, Honolulu, 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
Centralia Oncology Clinic, Centralia, Illinois, United States
Carle at The Riverfront, Danville, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Heartland Cancer Research NCORP, Decatur, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Cancer Care Center of O'Fallon, O'Fallon, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Carle Cancer Center NCORP, Urbana, Illinois, United States
Illinois CancerCare - Washington, Washington, Illinois, United States
Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Mission Cancer and Blood - Des Moines, 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
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
Minnesota Oncology - Burnsville, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, 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
Metro Minnesota Community Oncology Research Consortium, 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
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
Mercy Hospital Joplin, Joplin, Missouri, United States
Mercy Hospital South, Saint Louis, Missouri, United States
Mercy Hospital Saint Louis, Saint Louis, Missouri, United States
Cancer Research for the Ozarks NCORP, Springfield, Missouri, United States
Mercy Hospital Springfield, Springfield, 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
Nevada Cancer Research Foundation NCORP, 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
Urology Specialists of Nevada - Southwest, 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
Marietta Memorial Hospital, Marietta, Nevada, United States
Outer Banks Hospital, Nags Head, North Carolina, United States
Southeast Clinical Oncology Research Consortium, Winston-Salem, 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
Delaware/Christiana Care NCORP, Dayton, Ohio, United States
Mount Carmel Grove City Hospital, Grove City, 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 Cancer Institute NCORP, Dayton, 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, Mount Pleasant, South Carolina, United States
Chesapeake Regional Medical Center, Chesapeake, Virginia, United States
Hematology Oncology Associates of Fredericksburg Inc, Fredericksburg, Virginia, United States
Centra Lynchburg Hematology-Oncology Clinic Inc, 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
PeaceHealth Saint Joseph Medical Center, Bellingham, Washington, United States
PeaceHealth United General Medical Center, Sedro-Woolley, Washington, United States
ThedaCare Regional Cancer Center, Appleton, Wisconsin, United States
HSHS Sacred Heart Hospital, Eau Claire, Wisconsin, United States
Cancer Research of Wisconsin and Northern Michigan Consortium, Green Bay, 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
Westfields Hospital/Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Contact Details
Name: Oxana Palesh
Affiliation: University of Rochester NCORP Research Base
Role: PRINCIPAL_INVESTIGATOR
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