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Management of Insomnia in Breast Cancer Patients

Primary Purpose

Insomnia, Fatigue

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BBT-I
Control
Armodafinil
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Sham Comparator

Placebo Comparator

Arm Label

BBT-I + Armodafinil

Behavioral placebo + Armodafinil

BBT-I without Armodafinil

Behavioral placebo without Armodafinil

Arm Description

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.

Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.

Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention.

Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
November 9, 2009
Last Updated
November 1, 2018
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01011218
Brief Title
Management of Insomnia in Breast Cancer Patients
Official Title
Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Fatigue

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BBT-I + Armodafinil
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioral placebo + Armodafinil
Arm Type
Experimental
Arm Description
Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.
Arm Title
BBT-I without Armodafinil
Arm Type
Sham Comparator
Arm Description
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention.
Arm Title
Behavioral placebo without Armodafinil
Arm Type
Placebo Comparator
Arm Description
Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention.
Intervention Type
Behavioral
Intervention Name(s)
BBT-I
Other Intervention Name(s)
Brief Behavioral Intervention for Insomnia
Intervention Description
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
Intervention Type
Behavioral
Intervention Name(s)
Control
Other Intervention Name(s)
Behavioral placebo
Intervention Description
Control behavioral intervention is a sleep hygiene handout completed by participant.
Intervention Type
Drug
Intervention Name(s)
Armodafinil
Other Intervention Name(s)
Nuvigil
Intervention Description
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Primary Outcome Measure Information:
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
up to 32 Weeks
Secondary Outcome Measure Information:
Title
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Description
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.
Time Frame
up to 32 Weeks
Other Pre-specified Outcome Measures:
Title
The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
Description
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.
Time Frame
up to 32 Weeks
Title
Brief Fatigue Inventory (BFI)
Description
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.
Time Frame
up to 32 Weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Females with breast cancer
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oxana RG Palesh, PhD, MPH
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Management of Insomnia in Breast Cancer Patients

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