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

Primary Purpose

Breast Cancer, Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive Health Enhancement Support System
computer with internet
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Metastatic breast or prostate cancer patients and their primary caregivers Exclusion Criteria: Cannot be homeless

Sites / Locations

  • University of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1

2

Arm Description

internet access and computer for 1 year

computer and Full CHESS

Outcomes

Primary Outcome Measures

Improve caregiver burden
Improve affect, coping, self-efficacy and information competence

Secondary Outcome Measures

Mechanisms of CHESS effects

Full Information

First Posted
September 13, 2005
Last Updated
March 16, 2012
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT00214162
Brief Title
CHESS Caregivers Study: Web-based Support for Informal Caregivers in Cancer
Official Title
Web-based Support for Informal Caregivers in Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee
No

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Prostate Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
235 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
internet access and computer for 1 year
Arm Title
2
Arm Type
Experimental
Arm Description
computer and Full CHESS
Intervention Type
Behavioral
Intervention Name(s)
Comprehensive Health Enhancement Support System
Intervention Description
Full CHESS
Intervention Type
Behavioral
Intervention Name(s)
computer with internet
Intervention Description
computer with internet use x 1 year
Primary Outcome Measure Information:
Title
Improve caregiver burden
Time Frame
every 2 months
Title
Improve affect, coping, self-efficacy and information competence
Time Frame
every 2 months
Secondary Outcome Measure Information:
Title
Mechanisms of CHESS effects
Time Frame
every 2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Metastatic breast or prostate cancer patients and their primary caregivers Exclusion Criteria: Cannot be homeless
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gustafson, PhD
Organizational Affiliation
University of Wisconsin, Madison
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53706
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19687109
Citation
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.
Results Reference
background
PubMed Identifier
21041539
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.
Results Reference
background
PubMed Identifier
14987334
Citation
Wen KY, Gustafson DH. Needs assessment for cancer patients and their families. Health Qual Life Outcomes. 2004 Feb 26;2:11. doi: 10.1186/1477-7525-2-11.
Results Reference
result
PubMed Identifier
18579837
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 2008 Jun 25.
Results Reference
result
PubMed Identifier
20880656
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. 2010 Dec;81 Suppl:S94-9. doi: 10.1016/j.pec.2010.08.022. Epub 2010 Sep 28.
Results Reference
result
PubMed Identifier
29138131
Citation
Gustafson DH, DuBenske LL, Atwood AK, Chih MY, Johnson RA, McTavish F, Quanbeck A, Brown RL, Cleary JF, Shah D. Reducing Symptom Distress in Patients With Advanced Cancer Using an e-Alert System for Caregivers: Pooled Analysis of Two Randomized Clinical Trials. J Med Internet Res. 2017 Nov 14;19(11):e354. doi: 10.2196/jmir.7466.
Results Reference
derived
PubMed Identifier
22988042
Citation
Chih MY, DuBenske LL, Hawkins RP, Brown RL, Dinauer SK, Cleary JF, Gustafson DH. Communicating advanced cancer patients' symptoms via the Internet: a pooled analysis of two randomized trials examining caregiver preparedness, physical burden, and negative mood. Palliat Med. 2013 Jun;27(6):533-43. doi: 10.1177/0269216312457213. Epub 2012 Sep 17.
Results Reference
derived

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

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