Background: Sleep disturbances, particularly insomnia, are prevalent in cancer patients undergoing chemotherapy. Our clinically based Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI) is a new approach for treating insomnia symptoms during cancer care and can serve as a model for other behavioral interventions during medical treatment. Our design allows us to capture patients just as they are developing insomnia symptoms, but before their problems become chronic and require more intensive intervention. Our behavioral intervention is innovative because we can deliver it in tandem with patients? biomedical treatments, at the bedside, which significantly reduces patient burden. BBT-CI is a brief (2 face-to-face meetings, four 15-minute phone calls), feasible and acceptable intervention that has shown promise in reducing insomnia and other cancer-related side effects and in improving circadian rhythms at four community oncology clinic sites. Methods: The proposed project will test the efficacy of a novel BBT-CI in multiple private practice clinical oncology settings (n=20) across the country through the University of Rochester Cancer Center NCI Community Oncology Research Program (NCORP). We propose to randomize 400 cancer patients receiving chemotherapy to either BBT-CI or Healthy EAting Education Learning for healthy sleep (HEAL). Our HEAL control condition has been tested in our preliminary trial and is matched to BBT-CI for time and attention while excluding active components of the BBT-CI intervention (i.e., stimulus control, physical activity, circadian entrainment). The proposed innovative study will: 1) test the efficacy of a novel BBT-CI intervention in a community setting (NCORP network), 2) train nurses and clinical assistants to deliver the intervention in the infusion clinic, making it easier to disseminate in the future, and 3) elucidate the psychophysiology of insomnia and treatment response by collecting physiological circadian and autonomic nervous system markers. The proposed study aims to change the paradigm of how behavioral treatments can be delivered by creating and delivering the intervention in tandem with acute cancer care.

Public Health Relevance

Cancer is a common disorder; at some point during their lifetimes, one out of every three Americans will be diagnosed with cancer. Nearly 80% of cancer patients will experience either insomnia symptoms or insomnia disorder during chemotherapy. Insomnia is associated with numerous adverse health outcomes; it affects quality of life, contributes to fatigue, and may influence response to cancer treatments and survival. The proposed study will improve our understanding of insomnia pathophysiology and management in a clinical oncology community clinic.

Agency
National Institute of Health (NIH)
Institute
National Cancer Institute (NCI)
Type
Research Project (R01)
Project #
5R01CA239714-02
Application #
10087498
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Good, Marge
Project Start
2020-02-01
Project End
2025-01-31
Budget Start
2021-02-01
Budget End
2022-01-31
Support Year
2
Fiscal Year
2021
Total Cost
Indirect Cost
Name
Stanford University
Department
Psychiatry
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305