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Withdrawn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
About this trial
This is an interventional supportive care trial for Insomnia focused on measuring insomnia, breast cancer survivor, Internet intervention
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
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
NCT ID
NCT01141868
First Posted
June 9, 2010
Last Updated
May 16, 2013
Sponsor
Milton S. Hershey Medical Center
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Withdrawn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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