Neoplasms

Digestive System Diseases

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

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

Interactive Voice Response System

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

Symptoms Report

Xin Shelley Wang, MD

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.

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.

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

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

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Symptoms and General Pathology

Pancreatic Neoplasms

Neoplasm Metastasis

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

Questionnaires + Blood Draw + Pedometer used to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer.

Questionnaires including symptom review (MDSAI-GI) via personal or telephone interviews (interactive voice response telephone system - IVRS)

Questionnaires

Blood sample (3½ tbs.)to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) before treatment starts.

Blood Draws

Pedometer

Xin Shelley Wang, MD, MPH

The goal of this clinical research study is to learn about symptoms related to chemotherapy and the disease, in patients with advanced pancreatic cancer. Researchers will study the possible reason for these symptoms by drawing blood samples and comparing the test results to the symptoms you experience. The study will also use a special telephone system for measuring the symptoms of participants during and after therapy. Your level of physical activity will also be studied using a pedometer and study diary.

Researchers want to try to improve patient care for advanced pancreatic cancer by looking at how some symptoms create a great burden on daily life. They also want to find out which "markers" in the blood. Biomarkers are substances found in the blood, such as cytokines, certain proteins, and DNA changes. These biomarkers may help doctors predict "symptom burden" during therapy.

Researchers would also like to collect data about your physical function as part of this study. If you agree to wear a pedometer, you will wear the pedometer every day for a month during your waking hours. The pedometer used in the study is a small box that weighs less than an ounce and is smaller than a deck of playing cards. It is used to measure the number of steps you take during the day. Researchers will help you set the pedometer and show you how to use it. You will also keep a diary to record your use of the pedometer during this month. Researchers will meet with you during your clinic visits for chemotherapy at 2 weeks and 4 weeks to collect the data.

If you agree to take part in this study, you will have the following 4 types of study procedures performed:

Questionnaire:

Before chemotherapy that is scheduled by GI Medical Oncology Clinic starts, you will be asked to complete a questionnaire during a visit to the clinic. The questionnaire will measures physical and emotional symptoms. It should take about 5 minutes to finish. During this visit, the research staff will also teach you how to use the telephone system for measuring symptoms. You will tell the research staff the most convenient times for the telephone calls each week and the system will be set up to call you at that time.

Blood Draws:

Before you begin your chemotherapy treatments, you will have a sample of blood drawn (around 3½ tablespoons). The sample of blood will be used to measure levels of cytokines (biomarkers in the blood) and DNA (the genetic material in cells) in your blood before treatment starts. These cytokines may be related to symptoms experienced while having treatment for cancer.

You will have about 2½ tablespoons of blood drawn again when you complete first and second cycle of chemotherapy, and then at 2 months and 4 months after the start date of chemotherapy. Each blood sample will be drawn during your routine blood draw for continuing chemotherapy.

Symptoms Review:

You will have a MDASI-GI symptom assessment face to face, by regular mail, or through the phone calls. These will be used to measure symptom burden over time of the treatment and after treatment. The assessments will be done weekly for up to 4 months and then twice a month for up to an additional 14 months.

If your assessment is done by phone, it may be done by a study staff member or by using an interactive voice response telephone system (IVRS). During the study, the automated telephone system will call you once a week to ask you to rate your symptoms and how much the symptoms get in the way of your daily life. The information collected by these calls is only being used for this research study. This phone call should take about 5 minutes to complete.

This is an investigational study. Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.

Blood drawn (around 3½ tablespoons) before treatment starts to measure cytokines (biomarkers) and DNA.

Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

A Feasibility Study for Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Interactive Voice Response System (IVRS) for Managing Symptoms of Patients Following Thoracic Surgery	NCT00505024	Esophageal Canc... Lung Cancer	Interactive Voi... Symptoms Report	18 Years -	M.D. Anderson Cancer Center
Identifying the Role of Symptom Outcomes and Biomarkers in Survival in Patients With Metastatic Pancreatic Cancer	NCT00805688	Pancreatic Canc...	Questionnaires Blood Draws Pedometer	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for ivrs

Every month we try and update this database with for ivrs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ivrs

Every month we try and update this database with for ivrs cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ivrs cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.