Management of Insomnia in Breast Cancer Patients

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

To provide preliminary data on the effects of brief behavioral therapy for insomnia (BBT-I) on insomnia in breast cancer patients expecting to receive cancer treatment (unspecified).

Participants will be randomized into 4 groups:

• Arm 1: Brief Behavioral Treatment of Insomnia (BBT-I) + Armodafinil 150 mg/day.
• Arm 2: Behavioral therapy for insomnia (CBT-I) + Armodafinil 150 mg/day.
• Arm 3: Brief Behavioral Treatment of Insomnia (BBT-I) without pharmaceutical intervention.
• Arm 4: Behavioral therapy for insomnia (CBT-I) without pharmaceutical intervention.

Study Overview

• Status: Completed
• Conditions: Fatigue; Insomnia
• Intervention / Treatment: Behavioral: BBT-I; Drug: Armodafinil; Behavioral: Control

Detailed Description

The purpose of this study is to test the efficacy of Brief Behavioral Treatment of Insomnia (BBT-I) in the treatment of insomnia in humans.

Insomnia is an extraordinarily common problem for cancer patients that is often associated with diminished social and vocational functioning and QOL. It is also likely that insomnia exacerbates other cancer-related symptoms (eg, fatigue, nausea, depressive mood, pain and/or reduced pain tolerance) and thus gives rise to the possibility of additive or multiplicative interactions. It is possible that untreated insomnia in the context of cancer therapy may lead to chronic forms of insomnia in cancer survivors which, in turn, independently confers risk for increased psychiatric and medical morbidity.

Thus, insomnia, by itself, is a significant problem that requires better understanding in order that its high prevalence can be reduced.

Developing interventions that might prevent onset of insomnia in breast cancer patients is vital.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

INCLUSION CRITERIA

• Be scheduled for cancer treatment with chemotherapy or biologics (prior chemotherapy and/or diagnosis of metastatic breast are allowed)
• Have at least 6 weeks of treatment remaining
• ≥ 21 years old
• Able to understand written and spoken English
• Able to swallow medication (until amendment omitting armodafinil treatment)
• Score of 3+ on the Sleep Disruption Evaluation form, OR a score of 8+ on Insomnia Severity Index (ISI)

EXCLUSION CRITERIA

• Prior treatment with armodafinil or modafinil (until amendment omitting armodafinil treatment)
• Prior treatment with psycho-stimulant medication within the past 28 days (until amendment omitting armodafinil treatment)
• Prior treatment with antiseizure medications (until amendment omitting armodafinil treatment)
• Has continuously taken sleep medication daily for the last 28 days (until amendment omitting armodafinil treatment)
• History (self-reported) of unstable medical or psychiatric illness (within the last 5 years)
• History of uncontrolled, cardiac disease, hypertension, severe headaches, glaucoma, or seizures (until amendment omitting armodafinil treatment)
• Pregnant or nursing
• History of substance abuse or meet criteria for current alcohol abuse or dependence
• History (self-reported) of chronic, preexisting insomnia, sleep apnea, or restless leg syndrome (RLS)
• Severe hepatic impairment (until amendment omitting armodafinil treatment)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BBT-I + Armodafinil; Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. Armodafinil 150 mg/day by mouth.	Behavioral: BBT-I; Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone; Other Names: Brief Behavioral Intervention for Insomnia; Drug: Armodafinil; 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.; Other Names: Nuvigil
Experimental: Behavioral placebo + Armodafinil; Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.	Drug: Armodafinil; 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.; Other Names: Nuvigil; Behavioral: Control; Control behavioral intervention is a sleep hygiene handout completed by participant.; Other Names: Behavioral placebo
Sham Comparator: BBT-I without Armodafinil; Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention.	Behavioral: BBT-I; Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone; Other Names: Brief Behavioral Intervention for Insomnia
Placebo Comparator: Behavioral placebo without Armodafinil; Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention.	Behavioral: Control; Control behavioral intervention is a sleep hygiene handout completed by participant.; Other Names: Behavioral placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insomnia Severity Index (ISI)	Insomnia Severity Index (ISI) survey questionnaire is a 7-question survey, with each question having 5 possible answers (none, mild, moderate, severe, or very severe), scored as 0, 1, 2, 3, or 4, respectively. The full range of ISI scores is from 0 to 28. Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater insomnia. Clinical interpretation is as follows.; 0 to 7 No clinically significant insomnia; 8 to14 Subthreshold insomnia; 15 to 21 Clinical insomnia (moderate severity); 22 to 28 Clinical insomnia (severe) ISI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean ISI score with standard deviation.	up to 32 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)	The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) survey questionnaire is a 13-question subset of the 41-question Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) questionnaire, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of FACIT-Fatigue scores is from 0 to 52. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-Fatigue survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.	up to 32 Weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)	The full Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) survey questionnaire is a 41-question survey, with each question having 5 possible answers (not at all; a little bit; somewhat; quite a bit; very much), scored as 0, 1, 2, 3, or 4, respectively. The full range of scores is from 0 to 164. Higher scores are considered good, better, or healthy, and increasingly lower scores are considered to indicate greater fatigue. The FACIT-F survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean with standard deviation.	up to 32 Weeks
Brief Fatigue Inventory (BFI)	The Brief Fatigue Inventory (BFI) survey questionnaire is a 9-question survey, with each question having 11 possible answers ("No fatigue" to "As bad as you can imagine"), scored from 0 to 10, with each patient's overall BFI score being the mean of the values from each question (overall range 0 to 10). Lower scores are considered good, better, or healthy, and increasingly higher scores are considered to indicate greater fatigue. The BFI survey was conducted at baseline, 3 weeks, 6 weeks, 10 weeks, and 32 weeks. The outcome is reported as the mean of the overall BFI scores with standard deviation.	up to 32 Weeks

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Oxana RG Palesh, PhD, MPH, Stanford University

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): July 1, 2016

Study Registration Dates

• First Submitted: November 9, 2009
• First Submitted That Met QC Criteria: November 10, 2009
• First Posted (Estimate): November 11, 2009

Study Record Updates

• Last Update Posted (Actual): November 29, 2018
• Last Update Submitted That Met QC Criteria: November 1, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 Enzyme Inducers; Cytochrome P-450 CYP3A Inducers; Central Nervous System Stimulants; Wakefulness-Promoting Agents; Modafinil
• Other Study ID Numbers: IRB-17323; K07CA132916-01A1 (U.S. NIH Grant/Contract); 25740 (Other Identifier: University of Rochester - old protocol ID); BRS0008 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No