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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00214162
First received: September 13, 2005
Last updated: March 16, 2012
Last verified: March 2012
  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).


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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Web-based Support for Informal Caregivers in Cancer

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Improve caregiver burden [ Time Frame: every 2 months ] [ Designated as safety issue: No ]
  • Improve affect, coping, self-efficacy and information competence [ Time Frame: every 2 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Mechanisms of CHESS effects [ Time Frame: every 2 months ] [ Designated as safety issue: No ]

Enrollment: 235
Study Start Date: August 2004
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00214162

Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53706
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: David Gustafson, PhD University of Wisconsin, Madison
  More Information

Publications:
Additional 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, 1R01 NR008260-01
Study First Received: September 13, 2005
Last Updated: March 16, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Prostatic Neoplasms
Breast Diseases
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Skin Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014