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

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ClinicalTrials.gov Identifier: NCT00214162
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Behavioral: Comprehensive Health Enhancement Support System Behavioral: computer with internet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Web-based Support for Informal Caregivers in Cancer
Study Start Date : August 2004
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arms and Interventions
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Arm Intervention/treatment
1
internet access and computer for 1 year
 Behavioral: computer with internet
computer with internet use x 1 year
Experimental: 2
computer and Full CHESS
 Behavioral: Comprehensive Health Enhancement Support System
Full CHESS


Outcome Measures
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Primary Outcome Measures :
  1. Improve caregiver burden [ Time Frame: every 2 months ]
  2. Improve affect, coping, self-efficacy and information competence [ Time Frame: every 2 months ]

Secondary Outcome Measures :
  1. Mechanisms of CHESS effects [ Time Frame: every 2 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic breast or prostate cancer patients and their primary caregivers

Exclusion Criteria:

  • Cannot be homeless
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00214162


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: David Gustafson, PhD University of Wisconsin, Madison
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214162    
Other Study ID Numbers: 2002-436
1R01NR008260-01 ( U.S. NIH Grant/Contract )
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
 Neoplasms by Site
Neoplasms
Prostatic Diseases