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

NCT ID: NCT00214162

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

235 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Prostate Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

internet access and computer for 1 year

Group Type OTHER

computer with internet

Intervention Type BEHAVIORAL

computer with internet use x 1 year

2

computer and Full CHESS

Group Type EXPERIMENTAL

Comprehensive Health Enhancement Support System

Intervention Type BEHAVIORAL

Full CHESS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Comprehensive Health Enhancement Support System

Full CHESS

Intervention Type BEHAVIORAL

computer with internet

computer with internet use x 1 year

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Metastatic breast or prostate cancer patients and their primary caregivers

Exclusion Criteria

* Cannot be homeless
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

David Gustafson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 19687109 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21041539 (View on PubMed)

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.

Reference Type RESULT
PMID: 14987334 (View on PubMed)

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.

Reference Type RESULT
PMID: 18579837 (View on PubMed)

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.

Reference Type RESULT
PMID: 20880656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29138131 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22988042 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1R01NR008260-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2002-436

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mentor Integration Study
NCT00468468 COMPLETED NA