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Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy
Recruiting
Trial ID: NCT04829539
Purpose
This phase III trial compares BBT-CI to HEAL for the reduction of insomnia in patients with
stage I-III cancer who are receiving chemotherapy. Chemotherapy 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.
Official Title
Multicenter Randomized Controlled Trial Comparing Brief Behavioral Therapy for Cancer Related Insomnia (BBT-CI) and Healthy Eating Education Learning (HEAL)
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
Intervention(s):
behavioral: Behavioral Intervention
behavioral: Behavioral Intervention
other: Quality-of-Life Assessment
other: Questionnaire Administration
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305