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

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ClinicalTrials.gov Identifier: NCT01141868
Recruitment Status : Withdrawn (The study never opened due to technical upgrades that were needed for the SHUTi computer system.)
First Posted : June 11, 2010
Last Update Posted : May 17, 2013
Sponsor:
Information provided by:
Milton S. Hershey Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Insomnia Breast Cancer Behavioral: Internet Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
Study Start Date : July 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Internet Intervention Behavioral: Internet Intervention
online treatment for insomnia
Other Name: Internet
Experimental: Delayed Intervention
Receive access to the online Internet intervention after completing post-assessments.
Behavioral: Internet Intervention
online treatment for insomnia
Other Name: Internet



Primary Outcome Measures :
  1. sleep efficiency [ Time Frame: 6 weeks ]
    sleep-onset latency, wake after sleep onset, and number of awakenings


Secondary Outcome Measures :
  1. total sleep time [ Time Frame: 6 wks ]
    total hours of sleep per 24 hour period



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141868


Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Jane Schubart, PhD Penn State

Responsible Party: Jane Schubart, PhD, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT01141868     History of Changes
Other Study ID Numbers: 31944EP
First Posted: June 11, 2010    Key Record Dates
Last Update Posted: May 17, 2013
Last Verified: June 2010

Keywords provided by Milton S. Hershey Medical Center:
insomnia
breast cancer survivor
Internet intervention

Additional relevant MeSH terms:
Breast Neoplasms
Sleep Initiation and Maintenance Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders