We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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
Breast Cancer Prostate Cancer Behavioral: Comprehensive Health Enhancement Support System Behavioral: computer with internet

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
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

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



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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00214162     History of Changes
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