Trial ID or NCT#

NCT01011218

Status

NOT RECRUITING

Purpose

Primary Objective: 1. To provide preliminary data on the effects of armodafinil and Brief Behavioral Therapy for Insomnia (BBT-I) (alone or in combination) on insomnia in breast cancer patients receiving chemotherapy. Secondary Objectives: 1. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on cancer-related fatigue (CRF) in breast cancer patients receiving chemotherapy. 2. To provide preliminary data on the influence of armodafinil and BBT-I (alone or in combination) on QOL in breast cancer patients receiving chemotherapy. 3. To provide preliminary data on influence of armodafinil and BBT-I (alone or in combination) on endocrine and inflammatory physiological markers (measured by cortisol and inflammatory cytokines markers)

Official Title

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Eligibility Criteria

Ages Eligible for Study: Older than 21 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No

Investigator(s)

Oxana Palesh, Ph.D., M.P.H.
Psychologist
Assistant Professor of Psychiatry and Behavioral Sciences (Public Mental Health and Population Sciences) at the Stanford University Medical Center
Shruti Sheth
Medical oncologist, Breast specialist
Clinical Assistant Professor, Medicine - Oncology
David Spiegel, M.D.
Psychiatrist
Jack, Samuel and Lulu Willson Professor in Medicine
Frank E. Stockdale, MD, PhD
Medical oncologist, Breast specialist
Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus

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CONTACT

Oxana Palesh, PhD, MPH
(650) 725-7011