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Completed

NCT Number: NCT00505024

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

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.

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Key information

Conditions

Esophageal Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IVRS

Symptoms Report

Other

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

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.

    Time frame: 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.

    Time frame: 3 Years

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Jul 20, 2007
Registry last updated
Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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