Fatigue, Insomnia
Conditions
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.
Interventions
BEHAVIORALBBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
BEHAVIORALControl
Control behavioral intervention is a sleep hygiene handout completed by participant.
DRUGArmodafinil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 9 |
| Behavioral Placebo + Armodafinil 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. | 9 |
| 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.
BBT-I: Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | 26 |
| Behavioral Placebo Without Armodafinil 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. | 26 |
| Total | 70 |
Baseline characteristics
| Characteristic | BBT-I + Armodafinil | Behavioral Placebo + Armodafinil | BBT-I Without Armodafinil | Behavioral Placebo Without Armodafinil | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 23 Participants | 24 Participants | 65 Participants |
| Age, Continuous | 49.1 years STANDARD_DEVIATION 10.5 | 46.7 years STANDARD_DEVIATION 9.2 | 51.5 years STANDARD_DEVIATION 9 | 50.3 years STANDARD_DEVIATION 8.6 | 50.1 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 1 Participants | 4 Participants | 6 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 4 Participants | 17 Participants | 11 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants | 4 Participants | 5 Participants | 9 Participants | 23 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 5 Participants | 4 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 3 Participants | 3 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 8 Participants | 14 Participants | 16 Participants | 46 Participants |
| Region of Enrollment United States | 9 participants | 9 participants | 26 participants | 26 participants | 70 participants |
| Sex: Female, Male Female | 9 Participants | 9 Participants | 26 Participants | 26 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 1 / 9 | 1 / 26 | 1 / 26 |
| other Total, other adverse events | 9 / 9 | 9 / 9 | 5 / 26 | 3 / 26 |
| serious Total, serious adverse events | 1 / 9 | 1 / 9 | 1 / 26 | 1 / 26 |
Outcome results
Primary
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.
Time frame: up to 32 Weeks
Population: After baseline, it was not uncommon for participants to not contribute data for every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBT-I + Armodafinil | Insomnia Severity Index (ISI) | 10 Weeks | 6.0 units on a scale | Standard Deviation 3.6 |
| BBT-I + Armodafinil | Insomnia Severity Index (ISI) | 3 Weeks | 13.0 units on a scale | Standard Deviation 7.1 |
| BBT-I + Armodafinil | Insomnia Severity Index (ISI) | 32 Weeks | 3.0 units on a scale | — |
| BBT-I + Armodafinil | Insomnia Severity Index (ISI) | 6 Weeks | 9 units on a scale | Standard Deviation 6.1 |
| BBT-I + Armodafinil | Insomnia Severity Index (ISI) | Baseline | 16.3 units on a scale | Standard Deviation 7.4 |
| Behavioral Placebo + Armodafinil | Insomnia Severity Index (ISI) | 6 Weeks | 10 units on a scale | Standard Deviation 6.9 |
| Behavioral Placebo + Armodafinil | Insomnia Severity Index (ISI) | 10 Weeks | 8.3 units on a scale | Standard Deviation 5.6 |
| Behavioral Placebo + Armodafinil | Insomnia Severity Index (ISI) | 32 Weeks | 7.6 units on a scale | Standard Deviation 4.4 |
| Behavioral Placebo + Armodafinil | Insomnia Severity Index (ISI) | 3 Weeks | 10.8 units on a scale | Standard Deviation 6.5 |
| Behavioral Placebo + Armodafinil | Insomnia Severity Index (ISI) | Baseline | 14.6 units on a scale | Standard Deviation 6.3 |
| BBT-I Without Armodafinil | Insomnia Severity Index (ISI) | 6 Weeks | 8.0 units on a scale | Standard Deviation 5.7 |
| BBT-I Without Armodafinil | Insomnia Severity Index (ISI) | Baseline | 13.5 units on a scale | Standard Deviation 5.2 |
| BBT-I Without Armodafinil | Insomnia Severity Index (ISI) | 3 Weeks | 11.4 units on a scale | Standard Deviation 7.1 |
| BBT-I Without Armodafinil | Insomnia Severity Index (ISI) | 10 Weeks | 7.8 units on a scale | Standard Deviation 4.5 |
| BBT-I Without Armodafinil | Insomnia Severity Index (ISI) | 32 Weeks | 7.0 units on a scale | Standard Deviation 4.6 |
| Behavioral Placebo Without Armodafinil | Insomnia Severity Index (ISI) | 10 Weeks | 10.6 units on a scale | Standard Deviation 6.2 |
| Behavioral Placebo Without Armodafinil | Insomnia Severity Index (ISI) | 3 Weeks | 12.3 units on a scale | Standard Deviation 4.9 |
| Behavioral Placebo Without Armodafinil | Insomnia Severity Index (ISI) | Baseline | 12.1 units on a scale | Standard Deviation 5.4 |
| Behavioral Placebo Without Armodafinil | Insomnia Severity Index (ISI) | 6 Weeks | 10.5 units on a scale | Standard Deviation 6.5 |
| Behavioral Placebo Without Armodafinil | Insomnia Severity Index (ISI) | 32 Weeks | 8.1 units on a scale | Standard Deviation 6.3 |
Secondary
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.
Time frame: up to 32 Weeks
Population: After baseline, it was not uncommon for participants to not contribute data for every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBT-I + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 10 Weeks | 41.5 units on a scale | Standard Deviation 10 |
| BBT-I + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline | 27.2 units on a scale | Standard Deviation 27.3 |
| BBT-I + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 6 Weeks | 32.5 units on a scale | Standard Deviation 10.6 |
| BBT-I + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3 Weeks | 33.5 units on a scale | Standard Deviation 12.5 |
| BBT-I + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 32 Weeks | 51 units on a scale | — |
| Behavioral Placebo + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline | 29.1 units on a scale | Standard Deviation 8.2 |
| Behavioral Placebo + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 10 Weeks | 34.2 units on a scale | Standard Deviation 12.7 |
| Behavioral Placebo + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3 Weeks | 29.6 units on a scale | Standard Deviation 10.2 |
| Behavioral Placebo + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 32 Weeks | 35.8 units on a scale | Standard Deviation 4.32 |
| Behavioral Placebo + Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 6 Weeks | 33.7 units on a scale | Standard Deviation 11.4 |
| BBT-I Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3 Weeks | 29.4 units on a scale | Standard Deviation 11.3 |
| BBT-I Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline | 29.1 units on a scale | Standard Deviation 12.2 |
| BBT-I Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 6 Weeks | 33.1 units on a scale | Standard Deviation 12.4 |
| BBT-I Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 10 Weeks | 33.2 units on a scale | Standard Deviation 11.5 |
| BBT-I Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 32 Weeks | 37.9 units on a scale | Standard Deviation 11.9 |
| Behavioral Placebo Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 6 Weeks | 34.2 units on a scale | Standard Deviation 11.7 |
| Behavioral Placebo Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 3 Weeks | 31.0 units on a scale | Standard Deviation 11.5 |
| Behavioral Placebo Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | Baseline | 30.3 units on a scale | Standard Deviation 11.5 |
| Behavioral Placebo Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 32 Weeks | 35.9 units on a scale | Standard Deviation 10.8 |
| Behavioral Placebo Without Armodafinil | Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) | 10 Weeks | 34.5 units on a scale | Standard Deviation 13.8 |
Other Pre-specified
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.
Time frame: up to 32 Weeks
Population: After baseline, it was not uncommon for participants to not contribute data for every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBT-I + Armodafinil | Brief Fatigue Inventory (BFI) | 10 Weeks | 2.5 units on a scale | Standard Deviation 2.2 |
| BBT-I + Armodafinil | Brief Fatigue Inventory (BFI) | 6 Weeks | 4.0 units on a scale | Standard Deviation 2.5 |
| BBT-I + Armodafinil | Brief Fatigue Inventory (BFI) | 32 Weeks | 1.0 units on a scale | — |
| BBT-I + Armodafinil | Brief Fatigue Inventory (BFI) | 3 Weeks | 2.8 units on a scale | Standard Deviation 1.9 |
| BBT-I + Armodafinil | Brief Fatigue Inventory (BFI) | Baseline | 5.5 units on a scale | Standard Deviation 2.6 |
| Behavioral Placebo + Armodafinil | Brief Fatigue Inventory (BFI) | Baseline | 5.2 units on a scale | Standard Deviation 2 |
| Behavioral Placebo + Armodafinil | Brief Fatigue Inventory (BFI) | 3 Weeks | 4.2 units on a scale | Standard Deviation 2.5 |
| Behavioral Placebo + Armodafinil | Brief Fatigue Inventory (BFI) | 6 Weeks | 3.8 units on a scale | Standard Deviation 2.5 |
| Behavioral Placebo + Armodafinil | Brief Fatigue Inventory (BFI) | 32 Weeks | 3.6 units on a scale | Standard Deviation 2 |
| Behavioral Placebo + Armodafinil | Brief Fatigue Inventory (BFI) | 10 Weeks | 3.1 units on a scale | Standard Deviation 2.2 |
| BBT-I Without Armodafinil | Brief Fatigue Inventory (BFI) | 3 Weeks | 4.4 units on a scale | Standard Deviation 2.8 |
| BBT-I Without Armodafinil | Brief Fatigue Inventory (BFI) | 10 Weeks | 3.1 units on a scale | Standard Deviation 2.2 |
| BBT-I Without Armodafinil | Brief Fatigue Inventory (BFI) | 32 Weeks | 2.7 units on a scale | Standard Deviation 2.3 |
| BBT-I Without Armodafinil | Brief Fatigue Inventory (BFI) | Baseline | 4.4 units on a scale | Standard Deviation 2.7 |
| BBT-I Without Armodafinil | Brief Fatigue Inventory (BFI) | 6 Weeks | 3.0 units on a scale | Standard Deviation 2.4 |
| Behavioral Placebo Without Armodafinil | Brief Fatigue Inventory (BFI) | 3 Weeks | 4.0 units on a scale | Standard Deviation 2.5 |
| Behavioral Placebo Without Armodafinil | Brief Fatigue Inventory (BFI) | 6 Weeks | 3.4 units on a scale | Standard Deviation 2.3 |
| Behavioral Placebo Without Armodafinil | Brief Fatigue Inventory (BFI) | 10 Weeks | 3.4 units on a scale | Standard Deviation 2.6 |
| Behavioral Placebo Without Armodafinil | Brief Fatigue Inventory (BFI) | Baseline | 4.1 units on a scale | Standard Deviation 2.4 |
| Behavioral Placebo Without Armodafinil | Brief Fatigue Inventory (BFI) | 32 Weeks | 3.6 units on a scale | Standard Deviation 2.6 |
Other Pre-specified
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.
Time frame: up to 32 Weeks
Population: After baseline, it was not uncommon for participants to not contribute data for every time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| BBT-I + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 32 Weeks | 155 units on a scale | — |
| BBT-I + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 10 Weeks | 125.5 units on a scale | Standard Deviation 21.6 |
| BBT-I + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline | 99.3 units on a scale | Standard Deviation 32 |
| BBT-I + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 3 Weeks | 109.8 units on a scale | Standard Deviation 25.8 |
| BBT-I + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 6 Weeks | 110.8 units on a scale | Standard Deviation 24.1 |
| Behavioral Placebo + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 6 Weeks | 106.3 units on a scale | Standard Deviation 25.8 |
| Behavioral Placebo + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 3 Weeks | 99.2 units on a scale | Standard Deviation 26.8 |
| Behavioral Placebo + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline | 101.2 units on a scale | Standard Deviation 21.6 |
| Behavioral Placebo + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 32 Weeks | 118.2 units on a scale | Standard Deviation 11.9 |
| Behavioral Placebo + Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 10 Weeks | 111.2 units on a scale | Standard Deviation 29.6 |
| BBT-I Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 6 Weeks | 106.4 units on a scale | Standard Deviation 31.6 |
| BBT-I Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline | 100.0 units on a scale | Standard Deviation 26.2 |
| BBT-I Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 10 Weeks | 107.3 units on a scale | Standard Deviation 26.9 |
| BBT-I Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 32 Weeks | 118.1 units on a scale | Standard Deviation 29.2 |
| BBT-I Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 3 Weeks | 101.8 units on a scale | Standard Deviation 27.3 |
| Behavioral Placebo Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 3 Weeks | 103.3 units on a scale | Standard Deviation 29.5 |
| Behavioral Placebo Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | Baseline | 103.0 units on a scale | Standard Deviation 24.4 |
| Behavioral Placebo Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 32 Weeks | 116.4 units on a scale | Standard Deviation 23.4 |
| Behavioral Placebo Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 10 Weeks | 107.9 units on a scale | Standard Deviation 32 |
| Behavioral Placebo Without Armodafinil | The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) | 6 Weeks | 108.1 units on a scale | Standard Deviation 26.6 |