Effectiveness of the CHESS eHealth Cancer Support Intervention in Population-based Care

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Completed

CT.gov ID

NCT01033162

Collaborator

National Cancer Institute (NCI) (NIH)

368

Enrollment

Location

Arms

Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Primary Breast Cancer	Behavioral: Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

368 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Using Technology to Enhance Cancer Communication and Improve Clinical Outcome: Effectiveness of the CHESS Ehealth Cancer Support Intervention in Population-Based Care Study

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Aug 1, 2013

Actual Study Completion Date :

Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care A group using a Basic ICCS provided by KPNW
Experimental: Intervention A group using an enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)	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)

Arm

Intervention/Treatment

No Intervention: Usual Care

A group using a Basic ICCS provided by KPNW

Experimental: Intervention

A group using an enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)

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)

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kaiser Permanente Northwest	Portland	Oregon	United States	97227

Sponsors and Collaborators

University of Wisconsin, Madison
National Cancer Institute (NCI)

Investigators

Principal Investigator: Timothy Baker, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

University of Wisconsin Carbone Cancer Center

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT01033162

Other Study ID Numbers:

H-2008-0222
5P50CA095817
XP08323
NCI-2013-01101
A534253
SMPH/MEDICINE/MEDICINE*G

First Posted:

Dec 16, 2009

Last Update Posted:

Nov 18, 2019

Last Verified:

Feb 1, 2016

Study Results

No Results Posted as of Nov 18, 2019