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RECRUITINGPhase 3INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Be at least 18 years of age - Be diagnosed with cancer (stage I, II, III, or IV) with a expected to live 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 sleep medications are allowed

Treatments Being Tested

BEHAVIORAL

Behavioral Intervention

Receive BBT-CI

BEHAVIORAL

Behavioral Intervention

Receive HEAL

OTHER

Electronic Health Record Review

Ancillary studies

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Locations (20)

Kingman Regional Medical Center
Kingman, Arizona, United States
Mercy Hospital Fort Smith
Fort Smith, Arkansas, United States
Kaiser Permanente-Franklin
Denver, Colorado, United States
Kaiser Permanente-Rock Creek
Lafayette, Colorado, United States
Kaiser Permanente-Lone Tree
Lone Tree, Colorado, United States
Beebe South Coastal Health Campus
Millville, Delaware, United States
Helen F Graham Cancer Center
Newark, Delaware, United States
Medical Oncology Hematology Consultants PA
Newark, Delaware, United States
Beebe Health Campus
Rehoboth Beach, Delaware, United States
Memorial Health University Medical Center
Savannah, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii, United States
Queen's Cancer Cenrer - 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
Queen's Cancer Center - Kuakini
Honolulu, Hawaii, United States
The Cancer Center of Hawaii-Liliha
Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States
Tripler Army Medical Center
Honolulu, Hawaii, United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii, United States