Management of Insomnia in Breast Cancer Patients

Phase 2

Completed

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
BBT-I + Armodafinil	BBT-I	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 + Armodafinil	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.
Behavioral placebo + Armodafinil	Control	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.
BBT-I without Armodafinil	BBT-I	Two 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	Control	Control behavioral intervention is a sleep hygiene handout completed by participant. No pharmaceutical intervention.
Behavioral placebo + Armodafinil	Armodafinil	Control behavioral intervention is a sleep hygiene handout completed by participant. Armodafinil 150 mg/day by mouth.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.