MDACC Study Summary ID01-243 (Archived)

Study Summary
No. ID01-243:.......Lung......Charles Cleeland......Symptom Research

Study Summary Title



Study Summary Number:	ID01-243

Study Title:	Using an Interactive Voice Response Telephone System in the Assessment and Management of Symptoms in Advanced Lung Cancer Patients Receiving Chemotherapy

Physician

New Patient Referral



Name:	Charles Cleeland	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:	Lung	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	No visits specifically for the trial. Patients will be assessed at the end of the first cycle and at the end of the study.

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 study is to see if there is a better way to manage symptoms that patients who are receiving chemotherapy for lung cancer may experience. This study will test the usefulness of a special telephone system for monitoring the symptoms of patients receiving chemotherapy.

Study Objectives / Outcomes

This protocol tests the utility of feedback of patient symptoms gathered by an interactive voice response system (IVR) to the health care team in a randomized trial. Objectives are:

1. To compare the effectiveness of an interactive voice response (IVR) telephone triage/feedback system versus an interactive voice response telephone system with assessment only in monitoring and managing symptoms in patients with advanced lung cancer.

2. To compare differences in quality of life variables of patients using the IVR triage/feedback system versus IVR assessment only.

3. To compare the healthcare utilization (emergency visits, admissions, length of stay for hospitalizations for uncontrolled symptoms) of patients using the IVR triage/feedback system versus IVR assessment only.

Study Status Information



Study Activation / Registration Date:	04/23/2003

IRB Review and Approval Date:	03/13/2003

Study Type:

Recruitment Status:	Terminated

Projected Accrual:	136

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 diagnosed with stage III or IV NSCLC or SCLC (Patients who have received other prior chemotherapy are eligible.)

2) 18 years of age or older

3) English-speaking

4) Lives in the United States

5) Adequate vision and hearing to use the IVR system

6) Provides written informed consent

Exclusion Criteria:

1) Current diagnosis of psychosis or dementia

2) Patients unable to complete the assessment measures or unable to understand the purpose of the study

Links

Registration Number: NCT00423436
Study Information on Clinical Trials Registry (clinicaltrials.gov)