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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Hematopoietic and Lymphoid Cell Neoplasm
Intervention / Treatment

-

Contacts and Locations

Kingman

Kingman Regional Medical Center, Kingman, Arizona, United States, 86401

Fort Smith

Mercy Hospital Fort Smith, Fort Smith, Arkansas, United States, 72903

Oakland

Kaiser Permanente NCORP, Oakland, California, United States, 94612

Denver

Kaiser Permanente-Franklin, Denver, Colorado, United States, 80205

Lafayette

Kaiser Permanente-Rock Creek, Lafayette, Colorado, United States, 80026

Lone Tree

Kaiser Permanente-Lone Tree, Lone Tree, Colorado, United States, 80124

Frankford

Beebe South Coastal Health Campus, Frankford, Delaware, United States, 19945

Newark

Helen F Graham Cancer Center, Newark, Delaware, United States, 19713

Newark

Medical Oncology Hematology Consultants PA, Newark, Delaware, United States, 19713

Rehoboth Beach

Beebe Health Campus, Rehoboth Beach, Delaware, United States, 19971

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Rochester NCORP Research Base,

Oxana Palesh, PRINCIPAL_INVESTIGATOR, University of Rochester NCORP Research Base

Study Record Dates

2027-06-30