Clinical trial NCT04829539: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-04-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean change in the Insomnia Severity Index (ISI) total score
timeFrame: Baseline to day 49
Secondary outcomes:
measure: Mean change in Sleep Efficiency assessed via Actigraphy
timeFrame: Baseline to day 49
Other outcomes:
Locations:
city: Kingman
country: United States
facility: Kingman Regional Medical Center
state: Arizona
city: Fort Smith
country: United States
facility: Mercy Hospital Fort Smith
state: Arkansas
city: Oakland
country: United States
facility: Kaiser Permanente NCORP
state: California
city: Denver
country: United States
facility: Kaiser Permanente-Franklin
state: Colorado
city: Lafayette
country: United States
facility: Kaiser Permanente-Rock Creek
state: Colorado
city: Lone Tree
country: United States
facility: Kaiser Permanente-Lone Tree
state: Colorado
city: Frankford
country: United States
facility: Beebe South Coastal Health Campus
state: Delaware
city: Newark
country: United States
facility: Helen F Graham Cancer Center
state: Delaware
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants PA
state: Delaware
city: Rehoboth Beach
country: United States
facility: Beebe Health Campus
state: Delaware
city: 'Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Minority Underserved NCORP
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Bloomington
country: United States
facility: Illinois CancerCare-Bloomington
state: Illinois
city: Canton
country: United States
facility: Illinois CancerCare-Canton
state: Illinois
city: Carbondale
country: United States
facility: Memorial Hospital of Carbondale
state: Illinois
city: Carterville
country: United States
facility: SIH Cancer Institute
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Heartland Cancer Research NCORP
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Decatur
country: United States
facility: Heartland Cancer Research NCORP
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Galesburg
country: United States
facility: Illinois CancerCare-Galesburg
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Pekin
country: United States
facility: Illinois CancerCare-Pekin
state: Illinois
city: Peoria
country: United States
facility: Illinois CancerCare-Peoria
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center NCORP
state: Illinois
city: Washington
country: United States
facility: Illinois CancerCare - Washington
state: Illinois
city: Cedar Rapids
country: United States
facility: Physicians' Clinic of Iowa PC
state: Iowa
city: Des Moines
country: United States
facility: Iowa Methodist Medical Center
state: Iowa
city: Des Moines
country: United States
facility: Mission Cancer and Blood - Des Moines
state: Iowa
city: New Orleans
country: United States
facility: Louisiana State University Health Science Center
state: Louisiana
city: New Orleans
country: United States
facility: University Medical Center New Orleans
state: Louisiana
city: Elkton
country: United States
facility: Christiana Care - Union Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Burnsville
country: United States
facility: Minnesota Oncology - Burnsville
state: Minnesota
city: Coon Rapids
country: United States
facility: Mercy Hospital
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Maplewood
country: United States
facility: Minnesota Oncology Hematology PA-Maplewood
state: Minnesota
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: Metro Minnesota Community Oncology Research Consortium
state: Minnesota
city: Monticello
country: United States
facility: Monticello Cancer Center
state: Minnesota
city: New Ulm
country: United States
facility: New Ulm Medical Center
state: Minnesota
city: Saint Louis Park
country: United States
facility: Park Nicollet Clinic - Saint Louis Park
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Shakopee
country: United States
facility: Saint Francis Regional Medical Center
state: Minnesota
city: Willmar
country: United States
facility: Rice Memorial Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Wyoming
country: United States
facility: Fairview Lakes Medical Center
state: Minnesota
city: Ballwin
country: United States
facility: Saint Louis Cancer and Breast Institute-Ballwin
state: Missouri
city: Joplin
country: United States
facility: Mercy Hospital Joplin
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital South
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital Saint Louis
state: Missouri
city: Springfield
country: United States
facility: Cancer Research for the Ozarks NCORP
state: Missouri
city: Springfield
country: United States
facility: Mercy Hospital Springfield
state: Missouri
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada - Henderson
state: Nevada
city: Henderson
country: United States
facility: OptumCare Cancer Care at Seven Hills
state: Nevada
city: Henderson
country: United States
facility: Comprehensive Cancer Centers of Nevada-Southeast Henderson
state: Nevada
city: Henderson
country: United States
facility: Urology Specialists of Nevada - Green Valley
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Charleston
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Research Foundation NCORP
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Northwest
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at MountainView
state: Nevada
city: Las Vegas
country: United States
facility: Urology Specialists of Nevada - Northwest
state: Nevada
city: Las Vegas
country: United States
facility: Urology Specialists of Nevada - Southwest
state: Nevada
city: Las Vegas
country: United States
facility: Alliance for Childhood Diseases/Cure 4 the Kids Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Town Center
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada-Summerlin
state: Nevada
city: Las Vegas
country: United States
facility: Summerlin Hospital Medical Center
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Las Vegas
country: United States
facility: OptumCare Cancer Care at Fort Apache
state: Nevada
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada - Central Valley
state: Nevada
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Nevada
city: Nags Head
country: United States
facility: Outer Banks Hospital
state: North Carolina
city: Winston-Salem
country: United States
facility: Southeast Clinical Oncology Research Consortium
state: North Carolina
city: Belpre
country: United States
facility: Strecker Cancer Center-Belpre
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Columbus
country: United States
facility: The Mark H Zangmeister Center
state: Ohio
city: Dayton
country: United States
facility: Delaware/Christiana Care NCORP
state: Ohio
city: Grove City
country: United States
facility: Mount Carmel Grove City Hospital
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Westerville
country: United States
facility: Saint Ann's Hospital
state: Ohio
city: Newberg
country: United States
facility: Providence Newberg Medical Center
state: Oregon
city: Oregon City
country: United States
facility: Providence Willamette Falls Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Chadds Ford
country: United States
facility: Christiana Care Health System-Concord Health Center
state: Pennsylvania
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Dayton
country: United States
facility: Geisinger Cancer Institute NCORP
state: Pennsylvania
city: Hazleton
country: United States
facility: Geisinger Medical Center-Cancer Center Hazleton
state: Pennsylvania
city: Lewisburg
country: United States
facility: Geisinger Medical Oncology-Lewisburg
state: Pennsylvania
city: Pottsville
country: United States
facility: Geisinger Cancer Services-Pottsville
state: Pennsylvania
city: Scranton
country: United States
facility: Community Medical Center
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Wyoming Valley/Henry Cancer Center
state: Pennsylvania
city: Charleston
country: United States
facility: Roper Hospital
state: South Carolina
city: Charleston
country: United States
facility: Charleston Oncology - Roper
state: South Carolina
city: Charleston
country: United States
facility: Lowcountry Hematology Oncology PA-North Charleston
state: South Carolina
city: Charleston
country: United States
facility: Bon Secours Saint Francis Hospital
state: South Carolina
city: Charleston
country: United States
facility: Charleston Oncology - Saint Francis
state: South Carolina
city: Charleston
country: United States
facility: Lowcountry Hematology Oncology PA-West Ashley
state: South Carolina
city: Mount Pleasant
country: United States
facility: Lowcountry Hematology Oncology PA-Mount Pleasant
state: South Carolina
city: Chesapeake
country: United States
facility: Chesapeake Regional Medical Center
state: Virginia
city: Fredericksburg
country: United States
facility: Hematology Oncology Associates of Fredericksburg Inc
state: Virginia
city: Lynchburg
country: United States
facility: Centra Lynchburg Hematology-Oncology Clinic Inc
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: South Hill
country: United States
facility: VCU Community Memorial Health Center
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology PC
state: Virginia
city: Bellingham
country: United States
facility: PeaceHealth Saint Joseph Medical Center
state: Washington
city: Sedro-Woolley
country: United States
facility: PeaceHealth United General Medical Center
state: Washington
city: Appleton
country: United States
facility: ThedaCare Regional Cancer Center
state: Wisconsin
city: Eau Claire
country: United States
facility: HSHS Sacred Heart Hospital
state: Wisconsin
city: Green Bay
country: United States
facility: Cancer Research of Wisconsin and Northern Michigan Consortium
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center Green Bay
state: Wisconsin
city: Green Bay
country: United States
facility: Saint Vincent Hospital Cancer Center at Saint Mary's
state: Wisconsin
city: New Richmond
country: United States
facility: Westfields Hospital/Cancer Center of Western Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Rochester NCORP Research Base
name: Oxana Palesh
role: PRINCIPAL_INVESTIGATOR
References: