Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
Purpose
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.
Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Malignant Solid Neoplasm
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 psychotropics and sleep medication are allowed
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group I (BBT-CI) |
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. |
|
|
Active Comparator Group II (HEAL) |
Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. |
|
Recruiting Locations
Kingman Regional Medical Center
Kingman, Arizona 86401
Kingman, Arizona 86401
Mercy Hospital Fort Smith
Fort Smith, Arkansas 72903
Fort Smith, Arkansas 72903
Kaiser Permanente NCORP
Oakland, California 94612
Oakland, California 94612
Kaiser Permanente-Franklin
Denver, Colorado 80205
Denver, Colorado 80205
Kaiser Permanente-Rock Creek
Lafayette, Colorado 80026
Lafayette, Colorado 80026
Kaiser Permanente-Lone Tree
Lone Tree, Colorado 80124
Lone Tree, Colorado 80124
Beebe South Coastal Health Campus
Frankford, Delaware 19945
Frankford, Delaware 19945
Helen F Graham Cancer Center
Newark, Delaware 19713
Newark, Delaware 19713
Medical Oncology Hematology Consultants PA
Newark, Delaware 19713
Newark, Delaware 19713
Beebe Health Campus
Rehoboth Beach, Delaware 19971
Rehoboth Beach, Delaware 19971
Hawaii Cancer Care - Westridge
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Pali Momi Medical Center
'Aiea, Hawaii 96701
'Aiea, Hawaii 96701
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Hawaii Minority Underserved NCORP
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Queen's Cancer Center - POB I
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Queen's Medical Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Straub Clinic and Hospital
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
University of Hawaii Cancer Center
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Queen's Cancer Center - Kuakini
Honolulu, Hawaii 96817
Honolulu, Hawaii 96817
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
Honolulu, Hawaii 96826
Illinois CancerCare-Bloomington
Bloomington, Illinois 61704
Bloomington, Illinois 61704
Illinois CancerCare-Canton
Canton, Illinois 61520
Canton, Illinois 61520
Memorial Hospital of Carbondale
Carbondale, Illinois 62902
Carbondale, Illinois 62902
SIH Cancer Institute
Carterville, Illinois 62918
Carterville, Illinois 62918
Centralia Oncology Clinic
Centralia, Illinois 62801
Centralia, Illinois 62801
Carle at The Riverfront
Danville, Illinois 61832
Danville, Illinois 61832
Heartland Cancer Research NCORP
Decatur, Illinois 61526
Decatur, Illinois 61526
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
Decatur, Illinois 62526
Decatur Memorial Hospital
Decatur, Illinois 62526
Decatur, Illinois 62526
Heartland Cancer Research NCORP
Decatur, Illinois 62526
Decatur, Illinois 62526
Crossroads Cancer Center
Effingham, Illinois 62401
Effingham, Illinois 62401
Illinois CancerCare-Galesburg
Galesburg, Illinois 61401
Galesburg, Illinois 61401
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
O'Fallon, Illinois 62269
Illinois CancerCare-Pekin
Pekin, Illinois 61554
Pekin, Illinois 61554
Illinois CancerCare-Peoria
Peoria, Illinois 61615
Peoria, Illinois 61615
Carle Cancer Center NCORP
Urbana, Illinois 61801
Urbana, Illinois 61801
Illinois CancerCare - Washington
Washington, Illinois 61571
Washington, Illinois 61571
Physicians' Clinic of Iowa PC
Cedar Rapids, Iowa 52402
Cedar Rapids, Iowa 52402
Iowa Methodist Medical Center
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Mission Cancer and Blood - Des Moines
Des Moines, Iowa 50309
Des Moines, Iowa 50309
Louisiana State University Health Science Center
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
University Medical Center New Orleans
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Christiana Care - Union Hospital
Elkton, Maryland 21921
Elkton, Maryland 21921
Spectrum Health at Butterworth Campus
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
Burnsville, Minnesota 55337
Mercy Hospital
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
Fairview Southdale Hospital
Edina, Minnesota 55435
Edina, Minnesota 55435
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
Maplewood, Minnesota 55109
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Hennepin County Medical Center
Minneapolis, Minnesota 55415
Minneapolis, Minnesota 55415
Metro Minnesota Community Oncology Research Consortium
Minneapolis, Minnesota 55426
Minneapolis, Minnesota 55426
Monticello Cancer Center
Monticello, Minnesota 55362
Monticello, Minnesota 55362
New Ulm Medical Center
New Ulm, Minnesota 56073
New Ulm, Minnesota 56073
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
Saint Louis Park, Minnesota 55416
Regions Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
United Hospital
Saint Paul, Minnesota 55101
Saint Paul, Minnesota 55101
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
Shakopee, Minnesota 55379
Rice Memorial Hospital
Willmar, Minnesota 56201
Willmar, Minnesota 56201
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
Woodbury, Minnesota 55125
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
Wyoming, Minnesota 55092
Saint Louis Cancer and Breast Institute-Ballwin
Ballwin, Missouri 63011
Ballwin, Missouri 63011
Mercy Hospital Joplin
Joplin, Missouri 64804
Joplin, Missouri 64804
Mercy Hospital South
Saint Louis, Missouri 63128
Saint Louis, Missouri 63128
Mercy Hospital Saint Louis
Saint Louis, Missouri 63141
Saint Louis, Missouri 63141
Cancer Research for the Ozarks NCORP
Springfield, Missouri 65804
Springfield, Missouri 65804
Mercy Hospital Springfield
Springfield, Missouri 65804
Springfield, Missouri 65804
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
Henderson, Nevada 89052
OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
Henderson, Nevada 89052
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
Henderson, Nevada 89074
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
Henderson, Nevada 89074
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
Las Vegas, Nevada 89102
Nevada Cancer Research Foundation NCORP
Las Vegas, Nevada 89106
Las Vegas, Nevada 89106
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89128
Las Vegas, Nevada 89128
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
Las Vegas, Nevada 89135
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
Las Vegas, Nevada 89144
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
Las Vegas, Nevada 89148
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
Las Vegas, Nevada 89169
Marietta Memorial Hospital
Marietta, Nevada 45750
Marietta, Nevada 45750
Outer Banks Hospital
Nags Head, North Carolina 27959
Nags Head, North Carolina 27959
Southeast Clinical Oncology Research Consortium
Winston-Salem, North Carolina 27104
Winston-Salem, North Carolina 27104
Strecker Cancer Center-Belpre
Belpre, Ohio 45714
Belpre, Ohio 45714
Mount Carmel East Hospital
Columbus, Ohio 43213
Columbus, Ohio 43213
The Mark H Zangmeister Center
Columbus, Ohio 43219
Columbus, Ohio 43219
Delaware/Christiana Care NCORP
Dayton, Ohio 45459
Dayton, Ohio 45459
Mount Carmel Grove City Hospital
Grove City, Ohio 43123
Grove City, Ohio 43123
Knox Community Hospital
Mount Vernon, Ohio 43050
Mount Vernon, Ohio 43050
Licking Memorial Hospital
Newark, Ohio 43055
Newark, Ohio 43055
Saint Ann's Hospital
Westerville, Ohio 43081
Westerville, Ohio 43081
Providence Newberg Medical Center
Newberg, Oregon 97132
Newberg, Oregon 97132
Providence Willamette Falls Medical Center
Oregon City, Oregon 997045
Oregon City, Oregon 997045
Providence Portland Medical Center
Portland, Oregon 97213
Portland, Oregon 97213
Providence Saint Vincent Medical Center
Portland, Oregon 97225
Portland, Oregon 97225
Christiana Care Health System-Concord Health Center
Chadds Ford, Pennsylvania 19317
Chadds Ford, Pennsylvania 19317
Geisinger Medical Center
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
Geisinger Cancer Institute NCORP
Dayton, Pennsylvania 17822
Dayton, Pennsylvania 17822
Geisinger Medical Center-Cancer Center Hazleton
Hazleton, Pennsylvania 18201
Hazleton, Pennsylvania 18201
Geisinger Medical Oncology-Lewisburg
Lewisburg, Pennsylvania 17837
Lewisburg, Pennsylvania 17837
Geisinger Cancer Services-Pottsville
Pottsville, Pennsylvania 17901
Pottsville, Pennsylvania 17901
Community Medical Center
Scranton, Pennsylvania 18510
Scranton, Pennsylvania 18510
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
Wilkes-Barre, Pennsylvania 18711
Roper Hospital
Charleston, South Carolina 29401
Charleston, South Carolina 29401
Charleston Oncology - Roper
Charleston, South Carolina 29403
Charleston, South Carolina 29403
Lowcountry Hematology Oncology PA-North Charleston
Charleston, South Carolina 29406
Charleston, South Carolina 29406
Bon Secours Saint Francis Hospital
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Charleston Oncology - Saint Francis
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Lowcountry Hematology Oncology PA-West Ashley
Charleston, South Carolina 29414
Charleston, South Carolina 29414
Lowcountry Hematology Oncology PA-Mount Pleasant
Mount Pleasant, South Carolina 29464
Mount Pleasant, South Carolina 29464
Chesapeake Regional Medical Center
Chesapeake, Virginia 23320
Chesapeake, Virginia 23320
Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg, Virginia 22408
Fredericksburg, Virginia 22408
Centra Lynchburg Hematology-Oncology Clinic Inc
Lynchburg, Virginia 24501
Lynchburg, Virginia 24501
Virginia Cancer Institute
Richmond, Virginia 23230
Richmond, Virginia 23230
VCU Massey Cancer Center at Stony Point
Richmond, Virginia 23235
Richmond, Virginia 23235
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia 23298
Richmond, Virginia 23298
VCU Community Memorial Health Center
South Hill, Virginia 23970
South Hill, Virginia 23970
Shenandoah Oncology PC
Winchester, Virginia 22601
Winchester, Virginia 22601
PeaceHealth Saint Joseph Medical Center
Bellingham, Washington 98225
Bellingham, Washington 98225
PeaceHealth United General Medical Center
Sedro-Woolley, Washington 98284
Sedro-Woolley, Washington 98284
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
Appleton, Wisconsin 54911
HSHS Sacred Heart Hospital
Eau Claire, Wisconsin 54701
Eau Claire, Wisconsin 54701
Cancer Research of Wisconsin and Northern Michigan Consortium
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
Green Bay, Wisconsin 54301
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
Green Bay, Wisconsin 54303
Westfields Hospital/Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
New Richmond, Wisconsin 54017
More Details
- NCT ID
- NCT04829539
- Status
- Recruiting
- Sponsor
- University of Rochester NCORP Research Base
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.