Automated Telephone Monitoring for Symptom Management (ATSM)

December 6, 2011 updated by: Bill Given, Michigan State University
To improve the management of symptoms, patients with cancer undergoing chemotherapy will be monitored using an automated telephone system to record the severity of 15 prevalent symptoms for up to 8 consecutive weeks. Outcomes include; significant reduction in symptom severity and improvement in health states.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Overview: Prevalent symptoms among patients undergoing chemotherapy include: pain, fatigue, dry mouth, constipation, anorexia, nausea, sleep disturbance, shortness of breath or difficulty breathing, as well as psychological symptoms such as depression and anxiety. A survey of 1000 patients with cancer indicated that close to a quarter reported 10-12 symptoms. Given the impact of symptoms upon physical function, work, emotional distress, and hospitalizations, it is critical that strategies be developed and tested to improve symptom management.

This trial of a behavioural intervention for symptom management is significant because: 1) it contrasts a proactive approach, individualized to patients' symptom management needs, with a more conventional model that places responsibility on the patient for symptom management; 2) it controls for the method of delivery and the use of printed material; 3) it targets prevalent symptoms known to affect cancer patients undergoing chemotherapy; 4) it examines the relative effects of each arm, in terms of symptom severity (primary outcome), impact on patients' physical and social roles, and emotional distress; and 5) it explores these outcomes in terms of their impact on the use of services and costs of care.

Goal: The goal of this randomized trial is to determine if a nurse delivered Patient Assisted Management of Symptoms (PAMS) intervention individualized to patients' needs for symptom management, delivered by telephone, when compared to Telephone Information and Monitoring of Symptoms (TIMS) where symptoms are only monitored by telephone, with references to the symptom management toolkit will reduce symptom severity, improve physical function, and other outcomes.

Study Type

Interventional

Enrollment (Actual)

526

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 21 years of age or older
  • solid tumor cancer diagnosis
  • receiving chemotherapy treatment

Exclusion Criteria:

  • Emotional or psychology disorder for which patient is receiving treatment
  • does not speak English
  • does not have access to a telephone
  • difficulty hearing on the telephone

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse
Receives symptom management assistance from an oncology nurse via the telephone
Behavioral: Nurse
Receives 6 telephone calls over 8 weeks from an oncology nurse to assist with symptom management
Experimental: AVR
Receives symptom management assistance from an Automated telephone system
Behavioral: AVR
Receives 6 telephone calls over 8 weeks from an programmed automated telephone system to assist with symptom management

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Lower reported mean severity index among 7 prevalent symptoms
Time Frame: 9 weeks, 15 weeks
9 weeks, 15 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Reduced impact of physical role performance, improved social functioning, and reduced emotional distress; improved levels of communication between patients and providers; and improved patient satisfaction with care.
Time Frame: 9 weeks, 15 weeks
9 weeks, 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michigan State University

Investigators

  • Principal Investigator: Charles Given, PhD, Michigan State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Primary Completion (Actual)

November 1, 2006

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

November 25, 2008

First Submitted That Met QC Criteria

November 26, 2008

First Posted (Estimate)

November 27, 2008

Study Record Updates

Last Update Posted (Estimate)

December 7, 2011

Last Update Submitted That Met QC Criteria

December 6, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01CA030724 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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