MDACC Study Summary 2008-0327

Study Summary
No. 2008-0327:.......Psychosocial......Karen O. Anderson......Symptom Research

Study Summary Title



Study Summary Number:	2008-0327

Study Title:	Identification and Treatment of Depression in Underserved African American and Latino Patients with Cancer

Physician

New Patient Referral



Name:	Karen O. Anderson	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Symptom Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3505 Contact us about clinical trials

General Information



Disease Group:	Psychosocial	Supported By:	Robert Wood Johnson Foundation

Phase of Study:	N/A	Return Visit:	The participants will be seen for three evaluations at LBJ Hospital. The evaluations will be scheduled during the patients' clinic visits.

Treatment Agents:	Behavioral Intervention	Home Care:	No home care will be provided.

Treatment Loc:	Only outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	No hospitalizations are required.


Description/ Intervention:	The goal of this research study is to learn how well a telephone system works for improving the management of emotional distress, sadness, and/or depression in patients who are being treated for cancer.

Study Objectives / Outcomes

The proposed project will evaluate the feasibility and effectiveness of a novel computer-automated intervention for the assessment and treatment of depression that targets underserved minority patients and their providers.
The primary aim of the project is:
1. To evaluate the effectiveness of an interactive voice response (IVR) alert intervention for improving treatment of depression in underserved African American and Latino patients with cancer.

A secondary aim of the project is:
2. To determine the utility of a computer-automated telephone administered interactive voice response (IVR) system for identifying clinically significant depression in underserved African American and Latino patients with cancer.

Hypotheses:

1. It is hypothesized that patients in the novel interactive voice response (IVR) alert condition will receive improved treatment of depression, as compared to patients in the assessment only control condition.

2. It is hypothesized that patients' responses to the IVR assessment will be able to predict clinical depression.

Study Status Information



Study Activation / Registration Date:	03/12/2009

IRB Review and Approval Date:	09/30/2008

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	166

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) Diagnosis of cancer

2) Self-identified as African American or Latino

3) English or Spanish speaking

4) 18 years of age or older

5) Receiving treatment in the medical oncology, genitourinary oncology, or gynecologic oncology clinics at LBJ General Hospital

6) Reports a level of "4" or greater on the MDASI "sadness" and/or "distress" items.

Exclusion Criteria:

1) Not willing to use a telephone to report symptoms.

Links

Registration Number: NCT00863200
Study Information on Clinical Trials Registry (clinicaltrials.gov)