Evaluating an Internet-based Intervention for Insomnia in Breast Cancer Survivors
May 16, 2013 updated by: Milton S. Hershey Medical Center
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Internet Intervention
|
online treatment for insomnia
Other Names:
|
|
Experimental: Delayed Intervention
Receive access to the online Internet intervention after completing post-assessments.
|
online treatment for insomnia
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sleep efficiency
Time Frame: 6 weeks
|
sleep-onset latency, wake after sleep onset, and number of awakenings
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total sleep time
Time Frame: 6 wks
|
total hours of sleep per 24 hour period
|
6 wks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jane Schubart, PhD, Penn State
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
July 1, 2010
Study Completion (Actual)
July 1, 2010
Study Registration Dates
First Submitted
June 9, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimate)
June 11, 2010
Study Record Updates
Last Update Posted (Estimate)
May 17, 2013
Last Update Submitted That Met QC Criteria
May 16, 2013
Last Verified
June 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 31944EP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.