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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

Tracking Information
First Submitted Date  ICMJE September 13, 2005
First Posted Date  ICMJE September 21, 2005
Last Update Posted Date March 19, 2012
Study Start Date  ICMJE August 2004
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
  • Improve caregiver burden [ Time Frame: every 2 months ]
  • Improve affect, coping, self-efficacy and information competence [ Time Frame: every 2 months ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Improve caregiver burden
  • Improve affect, coping, self-efficacy and information competence.
Change History Complete list of historical versions of study NCT00214162 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Mechanisms of CHESS effects [ Time Frame: every 2 months ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Mechanisms of CHESS effects
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CHESS Caregivers Study: Web-based Support for Informal Caregivers in Cancer
Official Title  ICMJE Web-based Support for Informal Caregivers in Cancer
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).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Cancer
  • Prostate Cancer
Intervention  ICMJE
  • Behavioral: Comprehensive Health Enhancement Support System
    Full CHESS
  • Behavioral: computer with internet
    computer with internet use x 1 year
Study Arms  ICMJE
  • 1
    internet access and computer for 1 year
    Intervention: Behavioral: computer with internet
  • Experimental: 2
    computer and Full CHESS
    Intervention: Behavioral: Comprehensive Health Enhancement Support System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 16, 2012)
235
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
250
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Metastatic breast or prostate cancer patients and their primary caregivers

Exclusion Criteria:

  • Cannot be homeless
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00214162
Other Study ID Numbers  ICMJE 2002-436
1R01NR008260-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor  ICMJE University of Wisconsin, Madison
Collaborators  ICMJE National Institute of Nursing Research (NINR)
Investigators  ICMJE
Principal Investigator: David Gustafson, PhD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP