Management of Insomnia in Breast Cancer Patients

Status Completed

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.

Clinical Trial 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

Related Conditions & MeSH terms

Fatigue
Insomnia
Sleep Initiation and Maintenance Disorders

Clinical Trial Details

NCT number	NCT01011218
Study type	Interventional
Source	Stanford University
Contact
Status	Completed
Phase	Phase 2
Start date	January 2011
Completion date	July 2016

View Details

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