NCT01033162

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
368

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

November 18, 2019

Status Verified

February 1, 2016

Enrollment Period

3.8 years

First QC Date

December 14, 2009

Last Update Submit

November 14, 2019

Conditions

Primary Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Usual Care

NO INTERVENTION

A group using a Basic ICCS provided by KPNW

Intervention

EXPERIMENTAL

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.)

Interventions

Enhanced ICCS with KPNW web resources and the Comprehensive Health Enhancement Support System (CHESS.)BEHAVIORAL

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)

Intervention

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects must be within 2 months of their primary breast cancer diagnosis,
  • All subjects must be at least 18 years of age

You may not qualify if:

  • Illiterate
  • Homeless

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

Related Links

Study Officials

  • Timothy Baker

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2009

First Posted

December 16, 2009

Study Start

November 1, 2009

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

November 18, 2019

Record last verified: 2016-02

Locations

US(1)