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

Primary Purpose

Insomnia, Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet Intervention
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Insomnia focused on measuring insomnia, breast cancer survivor, Internet intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Internet Intervention

    Delayed Intervention

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    sleep efficiency
    sleep-onset latency, wake after sleep onset, and number of awakenings

    Secondary Outcome Measures

    total sleep time
    total hours of sleep per 24 hour period

    Full Information

    First Posted
    June 9, 2010
    Last Updated
    May 16, 2013
    Sponsor
    Milton S. Hershey Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01141868
    Brief Title
    Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
    Official Title
    Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2010
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The study never opened due to technical upgrades that were needed for the SHUTi computer system.
    Study Start Date
    July 2010 (undefined)
    Primary Completion Date
    July 2010 (Actual)
    Study Completion Date
    July 2010 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Milton S. Hershey Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Insomnia, Breast Cancer
    Keywords
    insomnia, breast cancer survivor, Internet intervention

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Internet Intervention
    Arm Type
    Experimental
    Arm Title
    Delayed Intervention
    Arm Type
    Experimental
    Arm Description
    Receive access to the online Internet intervention after completing post-assessments.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet Intervention
    Other Intervention Name(s)
    Internet
    Intervention Description
    online treatment for insomnia
    Primary Outcome Measure Information:
    Title
    sleep efficiency
    Description
    sleep-onset latency, wake after sleep onset, and number of awakenings
    Time Frame
    6 weeks
    Secondary Outcome Measure Information:
    Title
    total sleep time
    Description
    total hours of sleep per 24 hour period
    Time Frame
    6 wks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jane Schubart, PhD
    Organizational Affiliation
    Penn State
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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