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Study Summary
No. ID99-381:.......Kidney......Louis L. Pisters......Urology
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Study Summary Title
Study Summary
Number:
ID99-381
Study Title:The Effect of Depression, Social Support and Spirituality of the Survival of Patients with Metastatic Renal Cell Carcinoma
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Physician New Patient Referral
Name:Louis L. PistersPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:UrologyReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-3250
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:N/A
Phase of Study:N/AReturn
Visit:
None
Treatment
Agents:
NoneHome Care:Not required
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
Not applicable
Description/
Intervention:
Treatment: The goal of this clinical research study is to learn the effect of
depression, religion, and social support on survival of patients with
metastatic renal cell carcinoma.
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Study Objectives / Outcomes
To assess the effect of psychosocial and cultural factors on survival of patients with metastatic renal cell carcinoma and investigate the association between immune function and psychosocial variables. Specifically, we seek to assess the correlation between depressive symptoms, social support, coping skill, and religious factors (level of intrinsic religiousness, organized religious activity, and non-organized religious activity) on time to recurrence or progression and survival.

The study is designed to detect a survival difference between patients by their scores on the Hoge IR scale, the ORA scale, in the NORA scale, SF-36 Quality of Life Measure, the COPE, the CES-D, and the Duke Social Support Index. We will obtain two blood samples to examine dendritic cell function, NK cell numbers and cytotoxicity, circulating levels of Interferon and Interleukin 2, 4 and 10, and genetic and molecular markers. We will also obtain saliva samples for cortisol assays. One sample will be obtained at the recruitment visit (before any systemic treatment). To determine the circadian nature of cortisol, five samples a day (waking, 45 minutes later, 8 and 12 hours later, and at bedtime) will be obtained for three consecutive days (again before any systemic treatment). A single sample will also be obtained at the 6-month visit.
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Study Status Information
Study Activation / Registration Date:01/10/2000
IRB Review and Approval Date:01/05/2000
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:N/A
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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) Individuals with metastatic renal cell carcinoma, stages T1-4, N0-2, M0-1 (must be at least N1 or M1; cannot be both N0 and M0).

2) Age greater than 18 years

3) Absence of serious intercurrent illness

Exclusion Criteria:N/A

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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