Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00505024

Purpose

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:

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.
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.

Condition	Intervention
Esophageal Cancer Lung Cancer	Behavioral: Interactive Voice Response System Other: Symptoms Report

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Clinical Trial of the Efficacy of an Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders Lung Cancer Surgery

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To study 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. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	130
Study Start Date:	July 2006
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental IVRS Only	Behavioral: Interactive Voice Response System Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.
2: Experimental IVRS + Symptoms Report	Behavioral: Interactive Voice Response System Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10. Other: Symptoms Report A report of severe symptoms will be sent to your doctor or nurse.

Detailed Description:

The IVRS is a special telephone system that calls patients and asks questions about symptoms. The system can record and report severe symptoms to a patient's doctor by e-mail, fax, or pager. All patients are encouraged to report and discuss any severe symptoms to your treating clinicians.

If you agree to take part in this study, you will be randomly assigned (as in the toss of a coin) to 1 of 2 groups. Participants in one group will complete symptom surveys on the IVRS. Participants in the other group will complete symptom surveys on the IVRS, and (in addition) a report of severe symptoms will be sent to their doctor or nurse.

All participants will initially be asked to complete 2 surveys (before surgery) that will ask about any symptoms you may be having and your general quality of life. It will take about 10 minutes to complete both surveys. You will also be asked to provide some demographic information, such as your age, gender, employment status, and ethnicity.

Before you are discharged from the hospital (after your surgery), a member of the study staff will visit you and teach you how to use the IVRS system, and you will then continue participation according to your assigned group.

After you are discharged from the hospital, the system will be set up to call you (all participants) twice a week until 1 month after your surgery. It will be automated to ask you to rate 14 types of symptoms (such as pain, fatigue, nausea, sleep disturbance and 6 other items, such as how your symptoms interfere with your day-to-day activity, mood, and enjoyment of life) on a scale from 0 to 10. Zero (0) means that the symptom is not present, and 10 means that you are experiencing the symptom at its worst. The call should last from 3-5 minutes. For participants in the other group, a symptom report will also be sent to your doctor or nurse.

One month after surgery, you will have a phone call from a member of the research staff. During this phone call, you will be asked to provide additional information about the symptoms you experienced and how you managed them.This phone call will last about 20 minutes. If you are not able to be reached by research staff the first time you are called, you will be called again at another time between the 5th and 6th week after your surgery.

THIS IS AN INVESTIGATIONAL STUDY. Up to 130 patients (65 in each group) will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients scheduled for thoracic surgery for NSCLC, esophageal cancer and lung metastasis
Patients 18 years of age or older
Men and women of all ethnic groups who are English-speaking, and
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:

Patients with a current diagnosis of psychosis or dementia
Patients who have difficulty understanding the intent of the study
Patients who cannot complete the assessment tools independently

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00505024

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Xin Shelley Wang, MD

M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Xin Shelley Wang, MD/Associate Professor )
Study ID Numbers:	2006-0299
Study First Received:	July 18, 2007
Last Updated:	February 19, 2009
ClinicalTrials.gov Identifier:	NCT00505024 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Non-Small Cell Lung Cancer
Esophageal Cancer
Lung Cancer
Interactive Voice Response System
IVRS

Study placed in the following topic categories:

Thoracic Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Esophageal Cancer
Digestive System Diseases
Respiratory Tract Diseases
Esophageal Disorder

Lung Neoplasms
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Non-small Cell Lung Cancer
Esophageal Diseases
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:

Thoracic Neoplasms
Respiratory Tract Neoplasms
Digestive System Neoplasms
Gastrointestinal Diseases
Esophageal Neoplasms
Neoplasms
Digestive System Diseases

Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Head and Neck Neoplasms
Lung Diseases
Gastrointestinal Neoplasms
Esophageal Diseases

ClinicalTrials.gov processed this record on September 11, 2009