Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery

NCT00505024 | Completed DMC

• 1 other identifier: 2006-0299
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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. 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.

Conditions

Esophageal Cancer; Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 Years

Secondary Outcomes (1)

• 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.

  3 Years

Study Arms (2)

IVRS Only

EXPERIMENTAL

Behavioral: Interactive Voice Response System

IVRS + Symptoms Report

EXPERIMENTAL

Behavioral: Interactive Voice Response System; Other: Symptoms Report

Interventions

Interactive Voice Response System BEHAVIORAL

Calls twice weekly, where the system will ask you to rate types of symptoms on a scale from 0 to 10.

Also known as: IVRS

IVRS + Symptoms Report; IVRS Only

Symptoms Report OTHER

A report of severe symptoms will be sent to your doctor or nurse.

IVRS + Symptoms Report

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• The University of Texas M.D.Anderson Cancer Center

MeSH Terms

Conditions

Esophageal Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Study Officials

• Xin Shelley Wang, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2007
• First Posted: July 20, 2007
• Study Start: July 1, 2006
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (1)