# Multicenter Randomized Controlled Trial of Brief Behavioral Therapy for Cancer Related Insomnia

> **NIH NIH R01** · STANFORD UNIVERSITY · 2021 · $892,934

## Abstract

Abstract
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.

## Key facts

- **NIH application ID:** 10087498
- **Project number:** 5R01CA239714-02
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Oxana G Palesh
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $892,934
- **Award type:** 5
- **Project period:** 2020-02-01 → 2025-01-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10087498

## Citation

> US National Institutes of Health, RePORTER application 10087498, Multicenter Randomized Controlled Trial of Brief Behavioral Therapy for Cancer Related Insomnia (5R01CA239714-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10087498. Licensed CC0.

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