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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA214647 | U.S. NIH Grant/Contract | View source | |
| R01CA239714 | U.S. NIH Grant/Contract | View source | |
| UG1CA189961 | U.S. NIH Grant/Contract | View source | |
| NCI-2020-07175 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| URCC19185 | Other Identifier | University of Rochester NCORP Research Base | |
| URCC-19185 | Other Identifier | DCP | |
| URCC-19185 | Other Identifier | CTEP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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\
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (BBT-CI) | Experimental | Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. |
|
| Group II (HEAL) | Active Comparator | Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Intervention | Behavioral | Receive BBT-CI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Insomnia Severity Index (ISI) | Will evaluate the mean between arm difference in ISI score change from time point baseline to post-intervention. To assess this, will use analysis of covariance model with ISI at post-intervention as the outcome, study arm (group) as a fixed effect and baseline ISI as a covariate. Will test baseline group interaction. | post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency | Will be measured via actigraphy. | post intervention |
| Circadian phenomena | Circadian phenomena will be measured via actigraphy (Mesor, Acrophase, Amplitude, I < O dichotomy index). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oxana Palesh, PhD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingman Regional Medical Center | Kingman | Arizona | 86401 | United States | ||
| Mercy Hospital Fort Smith |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41170811 | Derived | Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2. |
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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.
| Behavioral Intervention | Behavioral | Receive HEAL |
|
|
| Electronic Health Record Review | Other | Ancillary studies |
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Up to 6 months post intervention |
| Fort Smith |
| Arkansas |
| 72903 |
| 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 | Millville | Delaware | 19967 | 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 |
| Memorial Health University Medical Center | Savannah | Georgia | 31404 | United States |
| Hawaii Cancer Care Inc - Waterfront Plaza | Honolulu | Hawaii | 96813 | United States |
| Queen's Cancer Cenrer - 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 |
| The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | 96817 | United States |
| Kapiolani Medical Center for Women and Children | Honolulu | Hawaii | 96826 | United States |
| Tripler Army Medical Center | Honolulu | Hawaii | 96859 | United States |
| Hawaii Cancer Care - Westridge | ‘Aiea | Hawaii | 96701 | United States |
| Pali Momi Medical Center | ‘Aiea | Hawaii | 96701 | United States |
| The Cancer Center of Hawaii-Pali Momi | ‘Aiea | Hawaii | 96701 | 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 |
| Illinois CancerCare-Carthage | Carthage | Illinois | 62321 | United States |
| Centralia Oncology Clinic | Centralia | Illinois | 62801 | United States |
| Carle at The Riverfront | Danville | Illinois | 61832 | United States |
| Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | 62526 | United States |
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States |
| Illinois CancerCare-Dixon | Dixon | Illinois | 61021 | United States |
| Crossroads Cancer Center | Effingham | Illinois | 62401 | United States |
| Illinois CancerCare-Eureka | Eureka | Illinois | 61530 | United States |
| Illinois CancerCare-Galesburg | Galesburg | Illinois | 61401 | United States |
| Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | 61443 | United States |
| Illinois CancerCare-Macomb | Macomb | Illinois | 61455 | United States |
| Cancer Care Center of O'Fallon | O'Fallon | Illinois | 62269 | United States |
| Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | 61350 | United States |
| Illinois CancerCare-Pekin | Pekin | Illinois | 61554 | United States |
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States |
| Illinois CancerCare-Peru | Peru | Illinois | 61354 | United States |
| Illinois CancerCare-Princeton | Princeton | Illinois | 61356 | United States |
| Carle Cancer Center | Urbana | Illinois | 61801 | United States |
| Illinois CancerCare - Washington | Washington | Illinois | 61571 | United States |
| UI Health Care Mission Cancer and Blood - Ankeny Clinic | Ankeny | Iowa | 50023 | United States |
| Physicians' Clinic of Iowa PC | Cedar Rapids | Iowa | 52402 | United States |
| Mercy Cancer Center-West Lakes | Clive | Iowa | 50325 | United States |
| UI Health Care Mission Cancer and Blood - West Des Moines Clinic | Clive | Iowa | 50325 | United States |
| Iowa Methodist Medical Center | Des Moines | Iowa | 50309 | United States |
| UI Health Care Mission Cancer and Blood - Des Moines Clinic | Des Moines | Iowa | 50309 | United States |
| Mercy Medical Center - Des Moines | Des Moines | Iowa | 50314 | United States |
| UI Health Care Mission Cancer and Blood - Laurel Clinic | Des Moines | Iowa | 50314 | 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 |
| Bronson Battle Creek | Battle Creek | Michigan | 49017 | United States |
| Corewell Health Grand Rapids Hospitals - Butterworth Hospital | Grand Rapids | Michigan | 49503 | United States |
| Trinity Health Grand Rapids Hospital | Grand Rapids | Michigan | 49503 | United States |
| Corewell Health Reed City Hospital | Reed City | Michigan | 49677 | 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 |
| Unity Hospital | Fridley | Minnesota | 55432 | 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 |
| 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 | 55102 | United States |
| Saint Francis Regional Medical Center | Shakopee | Minnesota | 55379 | United States |
| Ridgeview Medical Center | Waconia | Minnesota | 55387 | 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 |
| Parkland Health Center - Farmington | Farmington | Missouri | 63640 | United States |
| Mercy Hospital Joplin | Joplin | Missouri | 64804 | United States |
| Lake Regional Hospital | Osage Beach | Missouri | 65065 | United States |
| Sainte Genevieve County Memorial Hospital | Sainte Genevieve | Missouri | 63670 | United States |
| Mercy Hospital Springfield | Springfield | Missouri | 65804 | United States |
| Mercy Hospital South | St Louis | Missouri | 63128 | United States |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | United States |
| Mercy Hospital Saint Louis | St Louis | Missouri | 63141 | United States |
| Missouri Baptist Sullivan Hospital | Sullivan | Missouri | 63080 | United States |
| BJC Outpatient Center at Sunset Hills | Sunset Hills | Missouri | 63127 | 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 |
| Urology Specialists of Nevada - Southwest | Las Vegas | Nevada | 89113 | 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 |
| 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 |
| Waverly Hematology Oncology | Cary | North Carolina | 27518 | United States |
| Outer Banks Hospital | Nags Head | North Carolina | 27959 | 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 |
| Mount Carmel Grove City Hospital | Grove City | Ohio | 43123 | United States |
| Marietta Memorial Hospital | Marietta | Ohio | 45750 | 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 | 97045 | 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 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 | Mt. 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 Alan B Pearson Regional Cancer Center | Lynchburg | Virginia | 24501 | United States |
| Virginia Cancer Institute | Richmond | Virginia | 23229 | 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 |
| Valley Health / Winchester Medical Center | Winchester | Virginia | 22601 | United States |
| PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | 98225 | United States |
| PeaceHealth Saint John Medical Center | Longview | Washington | 98632 | United States |
| Valley Medical Center | Renton | Washington | 98055 | United States |
| PeaceHealth United General Medical Center | Sedro-Woolley | Washington | 98284 | United States |
| PeaceHealth Southwest Medical Center | Vancouver | Washington | 98664 | United States |
| ThedaCare Regional Cancer Center | Appleton | Wisconsin | 54911 | United States |
| HSHS Sacred Heart Hospital | Eau Claire | Wisconsin | 54701 | 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 |
| Cancer Center of Western Wisconsin | New Richmond | Wisconsin | 54017 | United States |
| Saint Vincent Hospital Cancer Center at Sturgeon Bay | Sturgeon Bay | Wisconsin | 54235-1495 | United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| ID | Term |
|---|---|
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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