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

Breast Cancer Clinical Trial

Official title:

Web-based Support for Informal Caregivers in Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00214162
• Other study ID #: 2002-436
• Secondary ID: 1R01NR008260-01
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: March 16, 2012
• Start date: August 2004
• Est. completion date: April 2008

Study information

• Verified date: March 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Metastatic breast or prostate cancer patients and their primary caregivers

Exclusion Criteria:

• Cannot be homeless

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer

Intervention

Behavioral:
• Comprehensive Health Enhancement Support System
Full CHESS
• computer with internet
computer with internet use x 1 year

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

References & Publications (5)

DuBenske LL, Burke Beckjord E, Hawkins RP, Gustafson DH. Psychometric evaluation of the Health Information Orientation Scale: a brief measure for assessing health information engagement and apprehension. J Health Psychol. 2009 Sep;14(6):721-30. doi: 10.1177/1359105309338892. — View Citation

Dubenske LL, Chih MY, Dinauer S, Gustafson DH, Cleary JF. Development and implementation of a clinician reporting system for advanced stage cancer: initial lessons learned. J Am Med Inform Assoc. 2008 Sep-Oct;15(5):679-86. doi: 10.1197/jamia.M2532. Epub 2 — View Citation

DuBenske LL, Chih MY, Gustafson DH, Dinauer S, Cleary JF. Caregivers' participation in the oncology clinic visit mediates the relationship between their information competence and their need fulfillment and clinic visit satisfaction. Patient Educ Couns. 2 — View Citation

DuBenske LL, Gustafson DH, Shaw BR, Cleary JF. Web-based cancer communication and decision making systems: connecting patients, caregivers, and clinicians for improved health outcomes. Med Decis Making. 2010 Nov-Dec;30(6):732-44. doi: 10.1177/0272989X10386382. Epub 2010 Nov 1. — View Citation

Wen KY, Gustafson DH. Needs assessment for cancer patients and their families. Health Qual Life Outcomes. 2004 Feb 26;2:11. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improve caregiver burden		every 2 months	No
Primary	Improve affect, coping, self-efficacy and information competence		every 2 months	Yes
Secondary	Mechanisms of CHESS effects		every 2 months	No