MDACC Study Summary 2006-0299 (Archived)

Study Summary
No. 2006-0299:.......Esophageal; Lung......Xin Shelley Wang......Symptom Research

Study Summary Title



Study Summary Number:	2006-0299

Study Title:	A Randomized Clinical Trial of the Efficacy of an Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery

Physician

New Patient Referral



Name:	Xin Shelley Wang	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:	713-745-3470 Contact us about clinical trials

General Information



Disease Group:	Esophageal Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Not applicable

Treatment Agents:	None	Home Care:	Not applicable

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	Not Applicable

Description/
Intervention:

The goal of this psychosocial research study is to learn the effectiveness of
the interactive voice response system (IVRS), which is designed to send a
report to a patient's doctor about severe symptoms they are experiencing.
Researchers want to learn if systematic symptom assessment (by the use of IVRS)
is another way to report symptoms rather than the usual method, which is
calling the doctor when there is a problem.

Study Objectives / Outcomes

To test the effectiveness of the interactive voice response telephone system with a triage/feedback component that incorporates timely symptom assessment, feedback to physicians, critical treatment guidelines for managing selected symptoms (distress, sleep disturbance, shortness of breath, constipation, and pain) in a cohort of cancer patients during the first month post-thoracic surgery.
This interactive voice response system (IVR) will be evaluated in a randomized clinical trial with an intervention group (IVR symptom assessment with triage) and a control group (IVR symptom assessment only).

We hypotheses that:
1. Patients in the MDASI-IVR plus triage group will have less symptom burden (less symptom severity, less symptom related interference, and better satisfaction of symptom control, better physical and emotional well-being) over the month of the trial compared to the control group.

2. Patients in the MDASI-IVR plus triage group will have more frequent documentation of symptom management in line with treatment guidelines compared to the control group.

Study Status Information



Study Activation / Registration Date:	07/07/2006

IRB Review and Approval Date:	05/25/2006

Study Type:	Behavioral

Recruitment Status:	Terminated

Projected Accrual:	N/A

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 scheduled for thoracic surgery for NSCLC, esophageal cancer and lung metastasis

2) Patients 18 years of age or older

3) Men and women of all ethnic groups who are English-speaking, and

4) Patients residing in the United States. (The IVR system is not yet available in other languages. The United States residency requirement (MDACC is an international referral center) will allow us to follow patients for the duration of the study.)

Exclusion Criteria:

1) Patients with a current diagnosis of psychosis or dementia

2) Patients who have difficulty understanding the intent of the study

3) Patients who cannot complete the assessment tools independently

Links

Registration Number: NCT00505024
Study Information on Clinical Trials Registry (clinicaltrials.gov)