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

Running, not enrolling · Phase 3

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

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.

Key facts

Study ID

NCT04829539

Run by

University of Rochester NCORP Research Base

People needed

400

Starts

2021-06-24

Expected to finish

2027-04-12

Last updated by the study team

2026-04-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• 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
• Pali Momi Medical Center — ‘Aiea, Hawaii, United States
• The Cancer Center of Hawaii-Pali Momi — ‘Aiea, Hawaii, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• Kingman Regional Medical Center — Kingman, Arizona, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.