Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors

NCT ID: NCT01141868

Last Updated: 2013-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2010-07-31

Brief Summary

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This study examines the efficacy of an Internet-delivered intervention to reduce symptoms of insomnia in breast cancer survivors. Breast cancer patients with insomnia (N=30) will be assigned to either gain access to the 6-week treatment program immediately (experimental group) or following study participation (control group).

Detailed Description

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Conditions

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Insomnia Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Internet Intervention

Group Type EXPERIMENTAL

Internet Intervention

Intervention Type BEHAVIORAL

online treatment for insomnia

Delayed Intervention

Receive access to the online Internet intervention after completing post-assessments.

Group Type EXPERIMENTAL

Internet Intervention

Intervention Type BEHAVIORAL

online treatment for insomnia

Interventions

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Internet Intervention

online treatment for insomnia

Intervention Type BEHAVIORAL

Other Intervention Names

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Internet

Eligibility Criteria

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Inclusion Criteria

* Female
* Diagnosed with breast cancer
* Age 18 and older
* Completed primary treatment at least one month prior to enrollment
* Diagnosis of insomnia

Exclusion Criteria

* Experiencing a sleep disorder other than insomnia (e.g., sleep apnea)
* Experiencing a major depressive episode or other serious psychiatric disturbance
* Modification of psychotropic medications within the previous month
* Undergoing current psychotherapy treatment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Milton S. Hershey Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Penn State College of Medicine, Penn State Milton S. Hershey Medical Center

Principal Investigators

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Jane Schubart, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State

Other Identifiers

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31944EP

Identifier Type: -

Identifier Source: org_study_id

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