# The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients

> **NIH NIH R21** · UNIVERSITY OF PENNSYLVANIA · 2022 · $417,828

## Abstract

Contact PD/PI: Perlis, Michael (w/ Muench, Alexandria)
ABSTRACT (PROJECT SUMMARY)
Insomnia and fatigue commonly occur during and/or after cancer treatment. While variable by
diagnosis and stage of illness, 30-60% of cancer patients endorse difficulty initiating and/or
maintaining sleep and 50-90% endorse fatigue. Despite these high prevalence rates, and the
substantial overlap in occurrence, most research related to cancer-related fatigue (CRF) has
assessed this pervasive and persistent symptom in a manner that does not take into account
sleep quality and quantity. This is, in part, due to the definition of CRF as “pathological levels of
persistent physical, emotional, and/or cognitive ‘enervation’ that appear not to be relieved, or
improved by, rest or sleep”. To date only a few studies have evaluated whether behavioral
treatments such as Cognitive Behavioral Therapy for Insomnia (CBT-I) can provide some relief to
patients who are experiencing CRF. The effect sizes for CBT-I outcomes, in the context of cancer,
have been found to be comparable to those observed in “primary insomnia”. The findings with
respect to CBT-I effects on CRF have been more modest. The smaller effects of CBT-I on CRF
may be due to a variety of factors, but one simple possibility is that CBT-I is under-dosed for
patients with cancer. In other words, subjects with cancer may require more sessions to achieve
sleep durations that can affect daytime fatigue. Accordingly, we propose to evaluate the
association between CBT-I dose (Low dose [4 or 8 sessions] or High Dose [10 or 12 sessions])
and changes in sleep duration and CRF. The study will enroll 70 subjects to obtain an analysis
sample of 60 subjects. Subjects will be diagnosed with breast cancer and will be between the
ages of 25-85 (inclusive). In order to allow age to be an analyzable factor, recruitment will be
stratified so that the following cohorts are equally populated (i.e., 25-45, 45-65, 65-85). The focus
of the R21 study will be on feasibility. The primary outcomes will be related to recruitment, subject
adherence, treatment acceptability, and subject retention. Descriptive data will also be obtained
to examine whether high dose CBT-I (i.e., larger improvements in sleep efficiency and/or sleep
duration) positively affects CRF. The study will be undertaken in collaboration with our program
post doc (Dr. Muench) as she transitions to Jr. Faculty and pursues this program of research on
a more independent basis. The study collaborators will also include: Dr. Knashawn Morales
(statistics); Dr. Sheila Garland (psycho-oncology & sleep); and Dr. Donn Posner (CBT-I).

## Key facts

- **NIH application ID:** 10433647
- **Project number:** 1R21CA270987-01
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Michael Lloyd Perlis
- **Activity code:** R21 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $417,828
- **Award type:** 1
- **Project period:** 2022-09-23 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10433647

## Citation

> US National Institutes of Health, RePORTER application 10433647, The Association Between CBT-I Dose, Sleep Duration, and Fatigue in Breast Cancer Patients (1R21CA270987-01). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10433647. Licensed CC0.

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