Expired Study
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Madison, Wisconsin 53706


Purpose:

Web-Based Support for Informal Caregivers in Cancer Brief Summary (including hypothesis): Informal caregivers need information, skills and emotional support to address physical, spiritual, and emotional needs associated with chronic illnesses including late stage cancer. Unfortunately, current conditions force clinicians to reduce their interaction time with patients and informal caregivers. Complimentary methods must be developed to provide needed information and support to caregivers. The proposed research will measure and explain the impact of two computer-based support systems that meet caregiver needs and facilitate information exchange with clinicians. The system, CHESS (Comprehensive Health Enhancement Support System) is a non-commercial computer system that provides patients with disease specific information, emotional support and skill building tools. In the expanded form to be tested in this study, CHESS with Caregiver Support (CGCHESS) will also provide the caregiver with more information, support and skills training related to palliative care. CGCHESS will be further enhanced to communicate essential patient and caregiver information to clinicians prior to a scheduled clinic visit and when patient symptoms exceed a threshold. The investigators' primary hypothesis is that CGCHESS + Clinician Report (CR) will reduce caregiver burden more than CGCHESS because of the additional support caregivers and patients receive from clinicians who have access to the CHESS clinician report. Secondary analyses will study the mechanisms of the CHESS effect. Specifically the investigators anticipate that the CHESS effect on caregivers will be mediated by the CHESS effect on interaction patterns with clinicians, satisfaction with clinical visits and by the CHESS effect on four patient outcomes (quality of life, negative affect, average severity of nine common late-stage cancers).


Criteria:

Inclusion Criteria: - Metastatic breast or prostate cancer patients and their primary caregivers Exclusion Criteria: - Cannot be homeless


Study is Available At:


Original ID:

2002-436


NCT ID:

NCT00214162


Secondary ID:

1R01 NR008260-01


Study Acronym:


Brief Title:

CHESS Caregivers Study: Web-based Support for Informal Caregivers in Cancer


Official Title:

Web-based Support for Informal Caregivers in Cancer


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Wisconsin, Madison


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Sing


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

235


Enrollment Type:

Actual


Overall Contact Information

Official Name:David Gustafson, PhD
Principal Investigator
University of Wisconsin, Madison

Study Dates

Start Date:August 2004
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:March 2012
Last Changed Date:March 16, 2012
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Improve caregiver burden
Time Frame:every 2 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Improve affect, coping, self-efficacy and information competence
Time Frame:every 2 months
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Mechanisms of CHESS effects
Time Frame:every 2 months
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Comprehensive Health Enhancement Support System
Description:Full CHESS
Arm Name:2
Intervention Type:Behavioral
Name:computer with internet
Description:computer with internet use x 1 year
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:2
Description:computer and Full CHESS
Study Arm Type:Other
Arm Name:1
Description:internet access and computer for 1 year

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Wisconsin, Madison
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institute of Nursing Research (NINR)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:DuBenske LL, Chih MY, Gustafson DH, Dinauer S, Cleary JF. Caregivers' participation in the oncology clinic visit mediates the relationship between their information competence and their need fulfillment and clinic visit satisfaction. Patient Educ Couns. 2010 Dec;81 Suppl:S94-9. Epub 2010 Sep 28.
PMID:20880656
Reference Type:Results Reference
Citation:Dubenske LL, Chih MY, Dinauer S, Gustafson DH, Cleary JF. Development and implementation of a clinician reporting system for advanced stage cancer: initial lessons learned. J Am Med Inform Assoc. 2008 Sep-Oct;15(5):679-86. Epub 2008 Jun 25.
PMID:18579837
Reference Type:Results Reference
Citation:Wen KY, Gustafson DH. Needs assessment for cancer patients and their families. Health Qual Life Outcomes. 2004 Feb 26;2:11. Review.
PMID:14987334
Reference Type:Reference
Citation:DuBenske LL, Gustafson DH, Shaw BR, Cleary JF. Web-based cancer communication and decision making systems: connecting patients, caregivers, and clinicians for improved health outcomes. Med Decis Making. 2010 Nov-Dec;30(6):732-44. Epub 2010 Nov 1.
PMID:21041539
Reference Type:Reference
Citation:DuBenske LL, Burke Beckjord E, Hawkins RP, Gustafson DH. Psychometric evaluation of the Health Information Orientation Scale: a brief measure for assessing health information engagement and apprehension. J Health Psychol. 2009 Sep;14(6):721-30.
PMID:19687109

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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