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

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 Sex
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 sleep medications 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)
Masking Description
After completion of all baseline assessments, the coordinator will tell the study participant which group they are in but will not reveal which intervention is hypothesized to have a greater effect on insomnia. Both interventions will be presented with equipoise. The investigator and the statistical team will be blinded to the intervention group. The rest of the study staff will not be blinded.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group I (BBT-CI) 		Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
  • 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
  • Other: Electronic Health Record Review
    Ancillary studies
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies
Active Comparator
Group II (HEAL) 		Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.
  • 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
  • Other: Quality-of-Life Assessment
    Ancillary studies
    Other names:
    • Quality of Life Assessment
  • Other: Questionnaire Administration
    Ancillary studies

Recruiting Locations

Kingman Regional Medical Center
Kingman 5301067, Arizona 5551752 86401
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Mercy Hospital Fort Smith
Fort Smith 4111410, Arkansas 4099753 72903
Contact:
Site Public Contact
800-378-9373

Kaiser Permanente-Franklin
Denver 5419384, Colorado 5417618 80205
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

Kaiser Permanente-Rock Creek
Lafayette 5427771, Colorado 5417618 80026
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

Kaiser Permanente-Lone Tree
Lone Tree 5429208, Colorado 5417618 80124
Contact:
Site Public Contact
303-720-2685
kristi.m.bronkan@kp.org

Beebe South Coastal Health Campus
Millville 4143696, Delaware 4142224 19967
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Helen F Graham Cancer Center
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Medical Oncology Hematology Consultants PA
Newark 4143861, Delaware 4142224 19713
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Beebe Health Campus
Rehoboth Beach 4144284, Delaware 4142224 19971
Contact:
Site Public Contact
302-291-6730
research@beebehealthcare.org

Memorial Health University Medical Center
Savannah 4221552, Georgia 4197000 31404
Contact:
Site Public Contact
912-350-7887
Lorraine.OHara@hcahealthcare.com

Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-524-6115
i.webster@hawaiicancercare.com

Queen's Cancer Cenrer - POB I
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-532-0315

Queen's Medical Center
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-545-8548

Straub Clinic and Hospital
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-522-4333

University of Hawaii Cancer Center
Honolulu 5856195, Hawaii 5855797 96813
Contact:
Site Public Contact
808-586-2979

Queen's Cancer Center - Kuakini
Honolulu 5856195, Hawaii 5855797 96817
Contact:
Site Public Contact
808-531-8521

The Cancer Center of Hawaii-Liliha
Honolulu 5856195, Hawaii 5855797 96817
Contact:
Site Public Contact
808-547-6881

Kapiolani Medical Center for Women and Children
Honolulu 5856195, Hawaii 5855797 96826
Contact:
Site Public Contact
808-983-6090

Tripler Army Medical Center
Honolulu 5856195, Hawaii 5855797 96859
Contact:
Site Public Contact
808-433-6336

Hawaii Cancer Care - Westridge
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-539-2273
info@hawaiicancercare.com

Pali Momi Medical Center
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-486-6000

The Cancer Center of Hawaii-Pali Momi
‘Aiea 5856430, Hawaii 5855797 96701
Contact:
Site Public Contact
808-678-9000

Illinois CancerCare-Bloomington
Bloomington 4885164, Illinois 4896861 61704
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Canton
Canton 4831990, Illinois 4896861 61520
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Memorial Hospital of Carbondale
Carbondale 4235193, Illinois 4896861 62902
Contact:
Site Public Contact
618-457-5200
clinical.research@sih.net

SIH Cancer Institute
Carterville 4235311, Illinois 4896861 62918
Contact:
Site Public Contact
618-985-3333
clinical.research@sih.net

Illinois CancerCare-Carthage
Carthage 4886716, Illinois 4896861 62321
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Centralia Oncology Clinic
Centralia 4235587, Illinois 4896861 62801
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Carle at The Riverfront
Danville 4889426, Illinois 4896861 61832
Contact:
Site Public Contact
800-446-5532
Research@Carle.com

Cancer Care Specialists of Illinois - Decatur
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Decatur Memorial Hospital
Decatur 4236895, Illinois 4896861 62526
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Dixon
Dixon 4889959, Illinois 4896861 61021
Contact:
Site Public Contact
815-285-7800

Crossroads Cancer Center
Effingham 4237727, Illinois 4896861 62401
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Eureka
Eureka 4891310, Illinois 4896861 61530
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Galesburg
Galesburg 4893392, Illinois 4896861 61401
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Kewanee Clinic
Kewanee 4898433, Illinois 4896861 61443
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Macomb
Macomb 4900817, Illinois 4896861 61455
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Cancer Care Center of O'Fallon
O'Fallon 4245926, Illinois 4896861 62269
Contact:
Site Public Contact
217-876-4762
morganthaler.jodi@mhsil.com

Illinois CancerCare-Ottawa Clinic
Ottawa 4905006, Illinois 4896861 61350
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Pekin
Pekin 4905599, Illinois 4896861 61554
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peoria
Peoria 4905687, Illinois 4896861 61615
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Peru
Peru 4905770, Illinois 4896861 61354
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Illinois CancerCare-Princeton
Princeton 4906818, Illinois 4896861 61356
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

Carle Cancer Center
Urbana 4914570, Illinois 4896861 61801
Contact:
Site Public Contact
800-446-5532
Research@carle.com

Illinois CancerCare - Washington
Washington 4915545, Illinois 4896861 61571
Contact:
Site Public Contact
309-243-3605
andersonj@illinoiscancercare.com

UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny 4846960, Iowa 4862182 50023
Contact:
Site Public Contact
515-241-3305

Physicians' Clinic of Iowa PC
Cedar Rapids 4850751, Iowa 4862182 52402
Contact:
Site Public Contact
319-297-2900

Mercy Cancer Center-West Lakes
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive 4852065, Iowa 4862182 50325
Contact:
Site Public Contact
515-241-3305

Iowa Methodist Medical Center
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-6727

UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines 4853828, Iowa 4862182 50309
Contact:
Site Public Contact
515-241-3305

Mercy Medical Center - Des Moines
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-358-6613
cancerresearch@mercydesmoines.org

UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines 4853828, Iowa 4862182 50314
Contact:
Site Public Contact
515-241-3305

Louisiana State University Health Science Center
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

University Medical Center New Orleans
New Orleans 4335045, Louisiana 4331987 70112
Contact:
Site Public Contact
504-210-3539
emede1@lsuhsc.edu

Christiana Care - Union Hospital
Elkton 4354234, Maryland 4361885 21921
Contact:
Site Public Contact
410-443-1360
frank.crum@christianacare.org

Bronson Battle Creek
Battle Creek 4985153, Michigan 5001836 49017
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Trinity Health Grand Rapids Hospital
Grand Rapids 4994358, Michigan 5001836 49503
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Corewell Health Reed City Hospital
Reed City 5006946, Michigan 5001836 49677
Contact:
Site Public Contact
616-391-1230
crcwm-regulatory@crcwm.org

Minnesota Oncology - Burnsville
Burnsville 5019767, Minnesota 5037779 55337
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Mercy Hospital
Coon Rapids 5022025, Minnesota 5037779 55433
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Southdale Hospital
Edina 5025264, Minnesota 5037779 55435
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Maplewood
Maplewood 5036588, Minnesota 5037779 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint John's Hospital - Healtheast
Maplewood 5036588, Minnesota 5037779 55109
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Abbott-Northwestern Hospital
Minneapolis 5037649, Minnesota 5037779 55407
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Hennepin County Medical Center
Minneapolis 5037649, Minnesota 5037779 55415
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Monticello Cancer Center
Monticello 5038045, Minnesota 5037779 55362
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

New Ulm Medical Center
New Ulm 5039173, Minnesota 5037779 56073
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Park Nicollet Clinic - Saint Louis Park
Saint Louis Park 5045021, Minnesota 5037779 55416
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Regions Hospital
Saint Paul 5045360, Minnesota 5037779 55101
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

United Hospital
Saint Paul 5045360, Minnesota 5037779 55102
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Francis Regional Medical Center
Shakopee 5046997, Minnesota 5037779 55379
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Ridgeview Medical Center
Waconia 5051640, Minnesota 5037779 55387
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Rice Memorial Hospital
Willmar 5052916, Minnesota 5037779 56201
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Minnesota Oncology Hematology PA-Woodbury
Woodbury 5053358, Minnesota 5037779 55125
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Fairview Lakes Medical Center
Wyoming 5053526, Minnesota 5037779 55092
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Louis Cancer and Breast Institute-Ballwin
Ballwin 4375663, Missouri 4398678 63011
Contact:
Site Public Contact
314-251-7058

Parkland Health Center - Farmington
Farmington 4386289, Missouri 4398678 63640
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Joplin
Joplin 4392768, Missouri 4398678 64804
Contact:
Site Public Contact
417-556-3074
esmeralda.carrillo@mercy.net

Lake Regional Hospital
Osage Beach 4402040, Missouri 4398678 65065
Contact:
Site Public Contact
573-302-2768
clinicaltrials@lakeregional.com

Sainte Genevieve County Memorial Hospital
Sainte Genevieve 4407294, Missouri 4398678 63670
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Springfield
Springfield 4409896, Missouri 4398678 65804
Contact:
Site Public Contact
417-269-4520

Mercy Hospital South
St Louis 4407066, Missouri 4398678 63128
Contact:
Site Public Contact
314-525-6042
Danielle.Werle@mercy.net

Missouri Baptist Medical Center
St Louis 4407066, Missouri 4398678 63131
Contact:
Site Public Contact
314-996-5569

Mercy Hospital Saint Louis
St Louis 4407066, Missouri 4398678 63141
Contact:
Site Public Contact
314-251-7066

Missouri Baptist Sullivan Hospital
Sullivan 4410669, Missouri 4398678 63080
Contact:
Site Public Contact
314-996-5569

BJC Outpatient Center at Sunset Hills
Sunset Hills 4410836, Missouri 4398678 63127
Contact:
Site Public Contact
314-996-5569

Comprehensive Cancer Centers of Nevada - Henderson
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Seven Hills
Henderson 5505411, Nevada 5509151 89052
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Green Valley
Henderson 5505411, Nevada 5509151 89074
Contact:
Site Public Contact
research@sncrf.org

OptumCare Cancer Care at Charleston
Las Vegas 5506956, Nevada 5509151 89102
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Southwest
Las Vegas 5506956, Nevada 5509151 89113
Contact:
Site Public Contact
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at MountainView
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Urology Specialists of Nevada - Northwest
Las Vegas 5506956, Nevada 5509151 89128
Contact:
Site Public Contact
research@sncrf.org

Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas 5506956, Nevada 5509151 89135
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Summerlin Hospital Medical Center
Las Vegas 5506956, Nevada 5509151 89144
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

OptumCare Cancer Care at Fort Apache
Las Vegas 5506956, Nevada 5509151 89148
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas 5506956, Nevada 5509151 89169
Contact:
Site Public Contact
702-384-0013
research@sncrf.org

Waverly Hematology Oncology
Cary 4459467, North Carolina 4482348 27518
Contact:
Site Public Contact
919-350-1700
TCHILDRESS@wakemed.org

Strecker Cancer Center-Belpre
Belpre 4506187, Ohio 5165418 45714
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel East Hospital
Columbus 4509177, Ohio 5165418 43213
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

The Mark H Zangmeister Center
Columbus 4509177, Ohio 5165418 43219
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Mount Carmel Grove City Hospital
Grove City 4513409, Ohio 5165418 43123
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Marietta Memorial Hospital
Marietta 4517586, Ohio 5165418 45750
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Knox Community Hospital
Mount Vernon 5163799, Ohio 5165418 43050
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Licking Memorial Hospital
Newark 5164466, Ohio 5165418 43055
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Saint Ann's Hospital
Westerville 5176472, Ohio 5165418 43081
Contact:
Site Public Contact
614-488-2745
Jeffh@columbusccop.org

Providence Newberg Medical Center
Newberg 5742726, Oregon 5744337 97132
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Willamette Falls Medical Center
Oregon City 5744253, Oregon 5744337 97045
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Portland Medical Center
Portland 5746545, Oregon 5744337 97213
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Providence Saint Vincent Medical Center
Portland 5746545, Oregon 5744337 97225
Contact:
Site Public Contact
503-215-2614
CanRsrchStudies@providence.org

Christiana Care Health System-Concord Health Center
Chadds Ford 4557084, Pennsylvania 6254927 19317
Contact:
Site Public Contact
302-623-4450
lbarone@christianacare.org

Geisinger Medical Center
Danville 5186327, Pennsylvania 6254927 17822
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Geisinger Medical Center-Cancer Center Hazleton
Hazleton 5193011, Pennsylvania 6254927 18201
Contact:
Site Public Contact
570-459-2901
HemonCCTrials@geisinger.edu

Geisinger Medical Oncology-Lewisburg
Lewisburg 5197842, Pennsylvania 6254927 17837
Contact:
Site Public Contact
570-374-8555
HemonCCTrials@geisinger.edu

Geisinger Cancer Services-Pottsville
Pottsville 5207080, Pennsylvania 6254927 17901
Contact:
Site Public Contact
800-275-6401
HemonCCTrials@geisinger.edu

Community Medical Center
Scranton 5211303, Pennsylvania 6254927 18510
Contact:
Site Public Contact
570-703-4768
HemonCCTrials@geisinger.edu

Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre 5219488, Pennsylvania 6254927 18711
Contact:
Site Public Contact
570-271-5251
HemonCCTrials@geisinger.edu

Chesapeake Regional Medical Center
Chesapeake 4752186, Virginia 6254928 23320
Contact:
Site Public Contact
CancerCare@ChesapeakeRegional.com

Hematology Oncology Associates of Fredericksburg Inc
Fredericksburg 4760059, Virginia 6254928 22408
Contact:
Site Public Contact
540-371-0079
cvaughn@hoafredericksburg.com

Centra Alan B Pearson Regional Cancer Center
Lynchburg 4771075, Virginia 6254928 24501
Contact:
Site Public Contact
434-200-1495
Kevin.Patel@centrahealth.com

Virginia Cancer Institute
Richmond 4781708, Virginia 6254928 23229
Contact:
Site Public Contact
804-287-3000
smoore@vacancer.com

VCU Massey Cancer Center at Stony Point
Richmond 4781708, Virginia 6254928 23235
Contact:
Site Public Contact
ctoclinops@vcu.edu

Virginia Commonwealth University/Massey Cancer Center
Richmond 4781708, Virginia 6254928 23298
Contact:
Site Public Contact
CTOclinops@vcu.edu

VCU Community Memorial Health Center
South Hill 4786619, Virginia 6254928 23970
Contact:
Site Public Contact
nemer.elmouallem@vcuhealth.org

Shenandoah Oncology PC
Winchester 4794120, Virginia 6254928 22601
Contact:
Site Public Contact
540-662-1108
William.Houck@usoncology.com

Valley Health / Winchester Medical Center
Winchester 4794120, Virginia 6254928 22601
Contact:
Site Public Contact
540-536-7820

PeaceHealth Saint Joseph Medical Center
Bellingham 5786899, Washington 5815135 98225
Contact:
Site Public Contact
360-788-8223

PeaceHealth Saint John Medical Center
Longview 5801617, Washington 5815135 98632
Contact:
Site Public Contact
360-514-2016
kmakin-bond@peacehealth.org

Valley Medical Center
Renton 5808189, Washington 5815135 98055
Contact:
Site Public Contact
425-228-3440
research@valleymed.org

PeaceHealth United General Medical Center
Sedro-Woolley 5809902, Washington 5815135 98284
Contact:
Site Public Contact
360-788-8223
rcrompton@peacehealth.org

PeaceHealth Southwest Medical Center
Vancouver 5814616, Washington 5815135 98664
Contact:
Site Public Contact
360-514-3940
kmakin-bond@peacehealth.org

ThedaCare Regional Cancer Center
Appleton 5244080, Wisconsin 5279468 54911
Contact:
Site Public Contact
920-364-3604
ResearchDept@thedacare.org

Saint Vincent Hospital Cancer Center Green Bay
Green Bay 5254962, Wisconsin 5279468 54301
Contact:
Site Public Contact
920-433-8889
WI_research_admin@hshs.org

Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay 5254962, Wisconsin 5279468 54303
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

Cancer Center of Western Wisconsin
New Richmond 5264475, Wisconsin 5279468 54017
Contact:
Site Public Contact
952-993-1517
mmcorc@healthpartners.com

Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay 5274867, Wisconsin 5279468 54235-1495
Contact:
Site Public Contact
920-433-8889
wi_research_admin@hshs.org

More Details

NCT ID
NCT04829539
Status
Recruiting
Sponsor
University of Rochester NCORP Research Base

Study Contact

Brooke Burgess, MS
585-274-2346
URCC_19185@urmc.rochester.edu

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.

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Vanderbilt University Medical Center