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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01033162
Other study ID # H-2008-0222
Secondary ID 5P50CA095817XP08
Status Completed
Phase N/A
First received
Last updated
Start date November 2009
Est. completion date August 2013

Study information

Verified date February 2016
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study's aim is to provide information about the clinical and business cases for comprehensive interactive cancer communication systems (ICCS) in the context of real world use for cancer care.

This study will be conducted within the Kaiser Permanente Northwest (KPNW) healthcare system. Outcomes for this study include amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits.


Recruitment information / eligibility

Status Completed
Enrollment 368
Est. completion date August 2013
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- All subjects must be within 2 months of their primary breast cancer diagnosis,

- All subjects must be at least 18 years of age

Exclusion Criteria:

- Illiterate

- Homeless

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)
Half of the participating women will be randomly assigned to use an informative but static website (Basic ICCS), and half will be offered a fully interactive CHESS (Enhanced ICCS + the Basic ICCS). Study outcome data will be gathered from patients, clinicians, and the healthcare system (i.e., from the electronic medical record: EMR) for at least 8 months after study entry. We propose that the Enhanced ICCS relative to the Basic ICCS, will: Improve patients' sense of cancer information competence (perceived ability to obtain and use relevant information) Reduce patients' negative affect and increase their emotional well being Improve patients' sense of social support Improve patients' health self-efficacy Improve patients' ratings of experience with cancer specialty care services Improve patients' health related quality of life (HRQL) Improve clinicians' ratings of quality of patient contacts Reduce healthcare utilization and costs (obtained via the EMR)

Locations

Country Name City State
United States Kaiser Permanente Northwest Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
University of Wisconsin, Madison National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amount of ICCS use and women's ratings of cancer information competence, perceived social support, and emotional well being. Secondary outcomes will include healthcare utilization, cost-effectiveness, and clinician ratings of healthcare visits. 12 Months
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