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

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Completed
CT.gov ID
NCT00214162
Collaborator
National Institute of Nursing Research (NINR) (NIH)
235
1
2
44
5.3

Study Details

Study Description

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
  • Behavioral: Comprehensive Health Enhancement Support System
  • Behavioral: computer with internet
N/A

Study Design

Study Type:
Interventional
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 :
Aug 1, 2004
Actual Primary Completion Date :
Apr 1, 2008
Actual Study Completion Date :
Apr 1, 2008

Arms and Interventions

Arm Intervention/Treatment
Other: 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

Primary Outcome Measures

  1. Improve caregiver burden [every 2 months]

  2. Improve affect, coping, self-efficacy and information competence [every 2 months]

Secondary Outcome Measures

  1. Mechanisms of CHESS effects [every 2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Metastatic breast or prostate cancer patients and their primary caregivers
Exclusion Criteria:
  • Cannot be homeless

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214162
Other Study ID Numbers:
  • 2002-436
  • 1R01NR008260-01
First Posted:
Sep 21, 2005
Last Update Posted:
Mar 19, 2012
Last Verified:
Mar 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 19, 2012