Status:
COMPLETED
Reducing Distress and Depressive-symptoms in Rural Women
Lead Sponsor:
University of Nebraska
Collaborating Sponsors:
University of Kansas Medical Center
Conditions:
Breast Cancer
Psychological Adjustment
Eligibility:
FEMALE
19-85 years
Phase:
NA
Brief Summary
Approximately 30% of U.S. breast cancer survivors experience significant cancer-related distress ranging from adjustment disorders, depression-symptoms and major depression up to 20 years after diagno...
Detailed Description
Of the 3.1 million U.S. breast cancer survivors, approximately 30% experience significant cancer-related distress ranging from sub-threshold to diagnosable adjustment disorders, depression-symptoms an...
Eligibility Criteria
Inclusion
- experiencing their first, stage 0 - IIIA breast cancer diagnosis (either clinical or definitive early stage at enrollment), and be 19 to 85 years of age,
- enroll \< 3 months post-diagnosis (as soon as possible after diagnosis is desirable),
- reside in a non-metro county of the United States according to the USDA Rural-Urban Continuum Codes (6 -9) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting Area (RUCA) codes (4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2-4, 8.0, 8.2-4, 9.0-2, 10.0, 10.2-6)
- be able to read and write in English since the CaringGuidance™ program is in English,
- have regular access (e.g. home or work) to high speed/satellite broadband Internet on desk/laptop or wireless iPad, Android or iPhone throughout the 3 months of the study,\*
- have an email address at which to receive CaringGuidance™ prompts,
- have a Baseline Distress Thermometer score of \> 4, or an Impact of Events Scale score of \> 9, or Center for Epidemiological Studies Depression Scale score of \> 16 (i.e. clinically meaningful thresholds).
- Able to comprehend and provide informed consent
Exclusion
- Men and women with recurrent or advanced breast cancer
- Those mentally or physically unable to read the consent form or other study materials and/or participate in the consent and engagement with the CaringGuidance program. Women who have been hospitalized for mental health issues or substance abuse in the past year are ineligible.
Key Trial Info
Start Date :
July 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2019
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03465813
Start Date
July 19 2017
End Date
May 30 2019
Last Update
September 25 2023
Active Locations (1)
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1
University of Nebraska Medical Center, Oncology Clinics
Omaha, Nebraska, United States, 68131