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NCT04829539 Clinical Trial

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

Malignant Solid Neoplasm Clinical Trial

Official title:
Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04829539
Other study ID # URCC19185
Secondary ID NCI-2020-07175UR
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 24, 2021
Est. completion date June 30, 2027

Study information
Verified date April 2024
Source University of Rochester
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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

Recruitment information / eligibility
Status Recruiting
Enrollment 400
Est. completion date June 30, 2027
Est. primary completion date January 30, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• Behavioral Intervention
Receive BBT-CI
• Behavioral Intervention
Receive HEAL
Other:
• Quality-of-Life Assessment
Ancillary studies
• Questionnaire Administration
Ancillary studies

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

Sponsors (2)
Lead Sponsor Collaborator
University of Rochester NCORP Research Base National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean change in the Insomnia Severity Index (ISI) total score The Insomnia Severity Index (ISI) is a validated self-report measure of insomnia. A 5-point Likert Scale of seven questions is used to rate each item (0=no problem; 4=very severe problem), yielding a total score ranging from 0-28 with higher scores indicating higher severity of insomnia. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL. Baseline to day 49
Secondary Mean change in Sleep Efficiency assessed via Actigraphy Actigraphy will assess sleep efficiency, calculated as the percent of total sleep time to time in bed. Higher percentage indicates better sleep efficiency. A linear mixed effects analysis of covariance model (ANCOVA) will be used to assess the statistical significance of the differences in mean change between BBT-CI and HEAL. Baseline to day 49
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