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

This study has been withdrawn prior to enrollment.
(The study never opened due to technical upgrades that were needed for the SHUTi computer system.)
Sponsor:
Information provided by:
Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT01141868
First received: June 9, 2010
Last updated: May 16, 2013
Last verified: June 2010
  Purpose

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 Intervention
Insomnia
Breast Cancer
Behavioral: Internet Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • sleep efficiency [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    sleep-onset latency, wake after sleep onset, and number of awakenings


Secondary Outcome Measures:
  • total sleep time [ Time Frame: 6 wks ] [ Designated as safety issue: No ]
    total hours of sleep per 24 hour period


Enrollment: 0
Study Start Date: July 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141868

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

No publications provided

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
Study First Received: June 9, 2010
Last Updated: May 16, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014