Management of Insomnia in Breast Cancer Patients
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ClinicalTrials.gov Identifier: NCT01011218 |
Recruitment Status :
Completed
First Posted : November 11, 2009
Results First Posted : October 9, 2018
Last Update Posted : November 29, 2018
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Supportive Care |
Conditions |
Insomnia Fatigue |
Interventions |
Behavioral: BBT-I Behavioral: Control Drug: Armodafinil |
Enrollment | 70 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil |
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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. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. |
Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. |
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone |
Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
Period Title: Overall Study | ||||
Started | 9 | 9 | 26 | 26 |
Completed | 9 | 9 | 26 | 26 |
Not Completed | 0 | 0 | 0 | 0 |
Arm/Group Title | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | Total | |
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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. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. |
Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil: 150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. |
Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone |
Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. Control: Control behavioral intervention is a sleep hygiene handout completed by participant. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 9 | 9 | 26 | 26 | 70 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
9 100.0%
|
9 100.0%
|
23 88.5%
|
24 92.3%
|
65 92.9%
|
|
>=65 years |
0 0.0%
|
0 0.0%
|
3 11.5%
|
2 7.7%
|
5 7.1%
|
|
Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
||||||
Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants | |
49.1 (10.5) | 46.7 (9.2) | 51.5 (9.0) | 50.3 (8.6) | 50.1 (9.0) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants | |
Female |
9 100.0%
|
9 100.0%
|
26 100.0%
|
26 100.0%
|
70 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants | |
Hispanic or Latino |
3 33.3%
|
1 11.1%
|
4 15.4%
|
6 23.1%
|
14 20.0%
|
|
Not Hispanic or Latino |
1 11.1%
|
4 44.4%
|
17 65.4%
|
11 42.3%
|
33 47.1%
|
|
Unknown or Not Reported |
5 55.6%
|
4 44.4%
|
5 19.2%
|
9 34.6%
|
23 32.9%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||||
Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
2 7.7%
|
2 2.9%
|
|
Asian |
0 0.0%
|
0 0.0%
|
5 19.2%
|
4 15.4%
|
9 12.9%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
2 7.7%
|
0 0.0%
|
2 2.9%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
2 7.7%
|
1 3.8%
|
3 4.3%
|
|
White |
8 88.9%
|
8 88.9%
|
14 53.8%
|
16 61.5%
|
46 65.7%
|
|
More than one race |
1 11.1%
|
1 11.1%
|
3 11.5%
|
3 11.5%
|
8 11.4%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants |
9 | 9 | 26 | 26 | 70 |
Name/Title: | Oxana RG Palesh, MD, PhD; Assistant Professor of Psychiatry and Behavioral Sciences |
Organization: | Stanford University Medical Center |
Phone: | 650-725-7011 |
EMail: | oxana.palesh@stanford.edu |
Responsible Party: | Oxana Palesh, Stanford University |
ClinicalTrials.gov Identifier: | NCT01011218 |
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 ) |
First Submitted: | November 9, 2009 |
First Posted: | November 11, 2009 |
Results First Submitted: | September 13, 2018 |
Results First Posted: | October 9, 2018 |
Last Update Posted: | November 29, 2018 |