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Study Summary
No. 2009-0268:.......Psychosocial......Javier O. Valenzuela......Symptom Research
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Study Summary Title
Study Summary
Number:		2009-0268
Study Title:Validation Study of a Spanish Version of the Brief Fatigue Inventory (BFI-Sp) and the
M. D. Anderson Symptom Inventory (MDASI-Sp)
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Physician New Patient Referral
Name:Javier O. ValenzuelaPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-563-1658
Contact us about clinical trials
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General Information
Disease Group:PsychosocialSupported By:N/A
Phase of Study:N/AReturn
Visit:		N/A
Treatment
Agents:		NoneHome Care:N/A
Treatment Loc:Only outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The purpose of this study is to learn more about common symptoms that may occur
in patients due to cancer and its treatment. We also want to learn more about
how symptoms affect your quality of life. One of the main goals of conducting
this survey is to learn how to better measure symptoms systematically when
caring for patients.
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Study Objectives / Outcomes
        The primary objectives of the study are:

        1. To validate a Spanish version of the Brief Fatigue Inventory (BFI-Sp) in a South American cancer sample assessing patients who currently have different degrees of cancer-related fatigue, and thus produce an instrument that is sensitive, reliable and valid for use in future clinical trials assessing fatigue in Spanish speaking South American cancer patients.

        2. To validate a Spanish version of the M.D. Anderson Symptom Inventory (MDASI-Sp) in a South American cancer sample assessing patients with different cancer types, who have undergone various treatments, and who have different levels of severity of cancer-related symptoms in Spanish speaking South American cancer patients.

        The secondary objectives of the study are:

        3. To study the symptom prevalence, severity and symptom interference in cancer patients treated at the Arturo Lopez Perez Cancer Center in Santiago, Chile.

        4. To determine the test-retest reliability of the BFI-Sp and MDASI-Sp in a group of patients receiving radiotherapy and/or chemotherapy.
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Study Status Information
Study Activation / Registration Date:08/25/2009
IRB Review and Approval Date:08/25/2009
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:148 patients
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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) In-patients and out-patients being followed in clinics at the Arturo Lopez Perez Cancer Center in Santiago, Chile.

2) Patients with a diagnosis of cancer confirmed by pathology (includes patients with active disease and those with no evidence of disease.)

3) Patients >/= 18 years of age.

4) Patient who are native Spanish speaking.

5) Patients will give written informed consent to participate.

6) Patients who are determined capable of completing the research.
Exclusion Criteria:1) Patients who cannot understand the intent of the study.

2) Patients who are not willing to complete the survey tools.
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Links
Registration Number: Not Applicable Clinical Trial
Other Links:
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Results

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