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Study Summary
No. ID00-168:.......Kidney......Lorenzo Cohen......Behavioral Science
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Study Summary Title
Study Summary
Number:
ID00-168
Study Title:Biobehavioral effects of emotional expression in cancer
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Physician New Patient Referral
Name:Lorenzo CohenPatients 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:713-745-4260
Contact us about clinical trials
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General Information
Disease Group:KidneySupported By:N/A
Phase of Study:N/AReturn
Visit:
N/A
Treatment
Agents:
NoneHome Care:N/A
Treatment Loc:Only at MDACC
Estimated
Length of Stay
in Houston:
N/A
Description/
Intervention:
The goal of this behavioral research study is to measure the psychological and
physiological benefits of an emotional expression program in patients with
kidney cancer. Researchers want to learn how the expression of emotions
affects quality of life, stress, and immune function.
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Study Objectives / Outcomes
The proposed study will assess the psychological and physiological benefits of an emotional expression intervention in patients with renal cancer. Patients will be randomly assigned to an emotional expression writing group or to a neutral writing group. This study will also evaluate the extent to which psychosocial factors mediate the intervention program and predict patients' recovery and adjustment to treatment. Potential mediators include level of cognitive processing, social networks/interactions, and sense of coherence and ability to find meaning in the illness experience.

Specific objectives of the proposed research are:

1) To evaluate an emotional expression intervention in patients with renal cancer. We will determine the extent to which an emotional expression writing-based intervention enhances adjustment during the first 12 months following diagnosis and treatment. Dimensions of adjustment will be assessed by examining indices of QOL, mental health, and stress (subjective symptoms of distress, perceived stress, and mood).

2) To determine the effects of an emotional expression writing-based intervention on immune function. The immune measures assessed in this study will include both general and autologous tumor–specific immune responses including cytotoxicity to K562 target cells; cytotoxicity to autologous tumor target cells; and functional assessment of type-1 and type-2 cytokines using autologous tumor and polyclonal stimulants.

3) To identify the psychosocial processes underlying the efficacy of the intervention.
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Study Status Information
Study Activation / Registration Date:
IRB Review and Approval Date:07/27/2000
Study Type:
Recruitment Status:Closed
Projected Accrual:710
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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) Men or woman older than 18 years with stage I-IV renal cell carcinoma 2) Zubrod performance status of less than or equal to 2 3) have no serious intercurrent medical illness 4) read and speak English

Exclusion Criteria:1) Score of 23 or below on the Mini-mental 2) History of primary or secondary immunodeficiency 3) Taking immunosuppressive drugs such as systemic corticosteroid 4) Patients who are undergoing a surgical procedure and do not sign the general tissue consent form 5) Patients with major psychiatric diagnoses or currently seeking psychological counseling.

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Links
Registration Number: NCT00505310
Study Information on Clinical Trials Registry (clinicaltrials.gov)

Other Links:
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Results


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