Management of Insomnia in Breast Cancer Patients

Insomnia Clinical Trial

Official title:

Management of Insomnia in Breast Cancer Patients: A Preliminary Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011218
• Other study ID #: IRB-17323
• Secondary ID: K07CA132916-01A1
• Status: Completed
• Phase: Phase 2
• Start date: January 2011
• Est. completion date: July 2016

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

• 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Fatigue
• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Behavioral:
• BBT-I
Brief Behavioral Intervention for Insomnia (BBT-I): 2 sessions in person and additional brief sessions over the phone
• Control
Control behavioral intervention is a sleep hygiene handout completed by participant.

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	up to 32 Weeks
Other	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.	up to 32 Weeks
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.	up to 32 Weeks
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.	up to 32 Weeks