NCT04829539|Active Not RecruitingPhase 3DMC

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

BBT-II

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

University of Rochester NCORP Research Base ClinicalTrials.gov

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6 other identifiers

URCC-19185R01CA214647R01CA239714UG1CA189961NCI-2020-07175URCC19185

Study Type

interventional

Target

400

Locations

1 country

Sites

153

Timeline

RegisteredApr 2021

StartedJun 2021

CompletionApr 2027

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

400

participants targeted

Target at P50-P75 for phase_3

Timeline

12mo left

Started Jun 2021

Longer than P75 for phase_3

Geographic Reach

1 country

153 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.8 years study duration

Study Progress84%

Jun 2021Apr 2027

First Submitted

Initial submission to the registry

March 11, 2021

Completed

22 days until next milestone

First Posted

Study publicly available on registry

April 2, 2021

Completed

3 months until next milestone

Study Start

First participant enrolled

June 24, 2021

Completed

5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2026

Expected

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 12, 2027

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

5.3 years

First QC Date

March 11, 2021

Last Update Submit

April 22, 2026

Conditions

Malignant Solid Neoplasm Hematopoietic and Lymphoid Cell Neoplasm

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

Sleep efficiency
post intervention
Circadian phenomena
Up to 6 months post intervention

Study Arms (2)

Group I (BBT-CI)

EXPERIMENTAL

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Behavioral: Behavioral InterventionOther: Electronic Health Record ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Group II (HEAL)

ACTIVE COMPARATOR

Patients complete face to face/video sessions with a trained staff member. Patients also complete phone sessions.

Behavioral: Behavioral InterventionOther: Electronic Health Record ReviewOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

Electronic Health Record ReviewOTHER

Ancillary studies

Group I (BBT-CI)Group II (HEAL)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (BBT-CI)Group II (HEAL)

Questionnaire AdministrationOTHER

Ancillary studies

Group I (BBT-CI)Group II (HEAL)

Behavioral InterventionBEHAVIORAL

Receive BBT-CI

Also known as: Behavior Conditioning Therapy, Behavior Modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, Behavioral Therapy, Behavioral Treatment, Behavioral Treatments

Group I (BBT-CI)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

University of Rochester NCORP Research Baselead
National Cancer Institute (NCI)collaborator

Study Sites (153)

Kingman Regional Medical Center

Kingman, Arizona, 86401, United States

Location

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903, United States

Location

Kaiser Permanente-Franklin

Denver, Colorado, 80205, United States

Location

Kaiser Permanente-Rock Creek

Lafayette, Colorado, 80026, United States

Location

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, 80124, United States

Location

Beebe South Coastal Health Campus

Millville, Delaware, 19967, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza