InsomniaPhase 2NCT01011218
Management of Insomnia in Breast Cancer Patients
A Phase 2 study testing BBT-I and Armodafinil in people with Insomnia and Fatigue, run by Stanford University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- What is being tested?
- BBT-I and Armodafinil
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 10Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- BBT-I, Control, Armodafinil
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBT-IBehavioural
Also called Brief Behavioral Intervention for Insomnia
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
ControlBehavioural
Also called Behavioral placebo
Control behavioral intervention is a sleep hygiene handout completed by participant.
ArmodafinilDrug
Also called Nuvigil
150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil.
| Study group | Role | What they receive |
|---|---|---|
| BBT-I + Armodafinil | Experimental | 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. Receives: Behavioral: BBT-I; Drug: Armodafinil |
| Behavioral placebo + Armodafinil | Experimental | Control behavioral intervention is a sleep hygiene handout completed by participant.
Armodafinil 150 mg/day by mouth. Receives: Behavioral: Control; Drug: Armodafinil |
| BBT-I without Armodafinil | Sham comparator | Two Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone.
No pharmaceutical intervention. Receives: Behavioral: BBT-I |
| Behavioral placebo without Armodafinil | Placebo comparator | Control behavioral intervention is a sleep hygiene handout completed by participant.
No pharmaceutical intervention. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 32 Weeks
Secondary outcomes (1)
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.
Measured: up to 32 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startJan 2011
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Oxana Palesh, Stanford University
- Investigators
- Oxana RG Palesh, PhD, MPH, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011218
- Sponsor's protocol ID
- IRB-17323
- Other IDs
- K07CA132916-01A1, 25740, BRS0008
- Status last verified
- Nov 2018
- First submitted
- 9 Nov 2009
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
PubMed 41170811
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study
- ClinicalTrials.gov ID
- NCT01011218
- Acronym / sponsor ID
- IRB-17323
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2011
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BBT-I + Armodafinil | Experimental | Behavioral: BBT-I, Drug: ArmodafinilTwo 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 placebo + Armodafinil | Experimental | Behavioral: Control, Drug: ArmodafinilControl behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth. |
| BBT-I without Armodafinil | Sham comparator | Behavioral: BBT-ITwo Brief Behavioral Therapy for Insomnia (BBT-I) sessions in person and additional brief BBT-I sessions over the phone. No pharmaceutical intervention. |
| Behavioral placebo without Armodafinil | Placebo comparator | Behavioral: ControlControl behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BBT-IAlso: Brief Behavioral Intervention for InsomniaBrief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone | Behavioural | BBT-I + Armodafinil, BBT-I without Armodafinil |
| ControlAlso: Behavioral placeboControl behavioral intervention is a sleep hygiene handout completed by participant. | Behavioural | Behavioral placebo + Armodafinil, Behavioral placebo without Armodafinil |
| ArmodafinilAlso: Nuvigil150 mg by mouth. Armodafinil is the enantiopure compound of the eugeroic modafinil (Provigil), containing only the (R)-(-)-enantiomer of the racemic modafinil. | Drug | BBT-I + Armodafinil, Behavioral placebo + Armodafinil |
Primary outcome
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.
1 secondary outcome
Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: up to 32 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41170811Cai Z, Tang Y, Liu C, Li H, Zhao G, Zhao Z, Zhang B. Cognitive behavioural therapy for insomnia in people with cancer. Cochrane Database Syst Rev. 2025 Oct 31;10(10):CD015176. doi: 10.1002/14651858.CD015176.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oxana RG Palesh, PhD, MPH principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BBT-I and Armodafinil in people with Insomnia and Fatigue, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: up to 32 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011218, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2018.