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Study Summary
No. 2005-0544:.......Lung......Cindy Carmack Taylor......Behavioral Science
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Study Summary Title
Study Summary
Number:
2005-0544
Study Title:Cancer Communications Systems - Expanding Use/Understanding: Clinician Integration Project
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Physician New Patient Referral
Name:Cindy Carmack TaylorPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3582
Contact us about clinical trials
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General Information
Disease Group:LungSupported By:N/A
Phase of Study:N/AReturn
Visit:
No visits are required as this psychosocial intervention is delivered over the
internet, which participants will access from their homes.
Treatment
Agents:
PsychosocialHome Care:Participants will access their assigned study conditons on the internet using
either their own home computer or one provided to them by the study.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this research study is to find out if you and the person with lung
cancer who you care for may be helped by getting information, support, and
decision making tools through the Comprehensive Health Enhancement Support
System (CHESS).
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Study Objectives / Outcomes
  • To compare the effect of CHESS with the Clinician Report to Usual Care on caregiver negative affect. As a primary outcome, we hypothesize that with the information, skills building and emotional support CHESS offers to caregivers, along with improving communication with clinicians through the Clinician Report, that caregivers given access to CHESS will experience significantly less negative affect, compared to a Usual Care control.
  • To conduct secondary analyses examining the effects of CHESS on patient and caregiver quality of life, symptom distress, health service use, caregiver burden, bereavement adjustment, as well as the differential effect of the treatments on patients of minority status. The secondary hypotheses predict that:
a) use of the CHESS system will have significantly positive effects on patient quality of life, symptom distress, health service use, caregiver quality of life, caregiver burden, and bereavement adjustment compared to a Usual Care control.
b) Minority status of caregivers (and patients) will interact with treatment condition, such that minorities will benefit more than Caucasians because they have fewer resources (outside of CHESS) to support then in their caregiving efforts.
  • To examine the mechanisms underlying the effects of CHESS, specifically exploring if they are mediated by symptom management, calls from clinicians, caregiving burden, coping self-efficacy, information competence, needs met at clinical visits and moderated by amount of CHESS or Internet use.
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Study Status Information
Study Activation / Registration Date:11/01/2005
IRB Review and Approval Date:08/17/2005
Study Type:Not Applicable
Recruitment Status:Closed
Projected Accrual:722
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients must be diagnosed with advanced (stage 3A, 3B or 4) non-small cell lung cancer, with a physician-projected lifespan of at least 4 months.

2) Patients must have a self-identified primary informal caregiver (primary person providing help and support) who agrees to participate in the study.

3) Patients and caregivers must be 18 years of age or older.

4) Patients and caregivers must able to read and write English at the 6th grade level (as shown by an ability to understand the informed consent).

5) Patients must be receiving care from a clinician who has consented to participate in this study.

Exclusion Criteria:1) Patients who are homeless and/or who have a homeless caregiver.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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