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Management of Insomnia in Breast Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01011218
Recruitment Status : Completed
First Posted : November 11, 2009
Results First Posted : October 9, 2018
Last Update Posted : November 29, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Oxana Palesh, Stanford University

Tracking Information
First Submitted Date  ICMJE November 9, 2009
First Posted Date  ICMJE November 11, 2009
Results First Submitted Date  ICMJE September 13, 2018
Results First Posted Date  ICMJE October 9, 2018
Last Update Posted Date November 29, 2018
Study Start Date  ICMJE January 2011
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Insomnia Severity Index (ISI) [ Time Frame: up to 32 Weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
Insomnia Severity Index [ Time Frame: pre, post, 3 months, 6 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2018)
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) [ Time Frame: up to 32 Weeks ]
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 10, 2009)
  • Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: pre, post, 3 months and 6 months ]
  • Brief Fatigue Inventory [ Time Frame: pre, post, at 3 and 6 months ]
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2018)
  • The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) [ Time Frame: up to 32 Weeks ]
    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.
  • Brief Fatigue Inventory (BFI) [ Time Frame: up to 32 Weeks ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Insomnia in Breast Cancer Patients
Official Title  ICMJE Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Insomnia
  • Fatigue
Intervention  ICMJE
  • Behavioral: BBT-I
    Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
    Other Name: Brief Behavioral Intervention for Insomnia
  • Behavioral: Control
    Control behavioral intervention is a sleep hygiene handout completed by participant.
    Other Name: Behavioral placebo
  • 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 Name: Nuvigil
Study Arms  ICMJE
  • 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.

    Interventions:
    • Behavioral: BBT-I
    • Drug: Armodafinil
  • Experimental: Behavioral placebo + Armodafinil

    Control behavioral intervention is a sleep hygiene handout completed by participant.

    Armodafinil 150 mg/day by mouth.

    Interventions:
    • Behavioral: Control
    • Drug: Armodafinil
  • 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.

    Intervention: Behavioral: BBT-I
  • Placebo Comparator: Behavioral placebo without Armodafinil

    Control behavioral intervention is a sleep hygiene handout completed by participant.

    No pharmaceutical intervention.

    Intervention: Behavioral: Control
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2018)
70
Original Estimated Enrollment  ICMJE
 (submitted: November 10, 2009)
60
Actual Study Completion Date  ICMJE July 2016
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Females with breast cancer
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01011218
Other Study ID Numbers  ICMJE IRB-17323
K07CA132916-01A1 ( U.S. NIH Grant/Contract )
25740 ( Other Identifier: University of Rochester - old protocol ID )
BRS0008 ( Other Identifier: OnCore )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Oxana Palesh, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Oxana RG Palesh, PhD, MPH Stanford University
PRS Account Stanford University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP