Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Provider Unrelieved Symptom Alert

• Registration Number: NCT01979146
• Lead Sponsor: University of Utah

Brief Summary

The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.

Detailed Description

The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue. The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications. All participants called the automated system daily to report their symptom presence, severity, and distress. When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse. The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers. Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms. The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress. Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded. In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2001-04
• Primary Completion: 2004-03
• Study Completion: 2004-03
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

• Adult (18 or older)
• Histological Diagnosis of Cancer
• Life Expectancy of at least 6 months
• Cognitively able to participate (verified by provider team)
• Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
• Had Poorly controlled symptoms during the first cycle of chemotherapy
• Care under the direction of one of the designated provider teams
• English or Spanish speaking
• Has access to a telephone on a daily basis
• Able to use the telephone unassisted

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Exclusion Criteria

• Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
• Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
• Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Provider Unrelieved Symptom Alert	Provider Unrelieved Symptom Alert	Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms. The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels). Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days.

Primary Outcome Measures

Name	Time	Method
Patient reported symptom levels on a 0-10 scale	patients report symptoms daily for the duration of the study, an expected average of 6 weeks	During daily automated calls, patients provided information about common chemotherapy symptoms.

Secondary Outcome Measures

Name	Time	Method
Medical Encounters Telephone Interview	participants will be followed for an expected average of 6 weeks	When a patient reports during their daily phone call with the automated symptom monitoring system that they had been in contact with a health care provider, the research staff would conduct a short telephone interview to collect data about the nature of the medical encounter including whether the medical encounter was related to the symptoms being monitored by the system.
Work Attendance	reported daily, participants will be followed for an expected average of 6 weeks	Patients who indicated at study enrollment that they planned to work during treatment answered a yes/no question during the automated symptom monitoring system call to report whether or not they worked the previous day.
Functional Status	monthly for the duration of the study, participants will be followed for an expected average of 6 weeks	The SF-12 was administered monthly to measure functional status.

Trial Locations

Locations (3)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

South Carolina Community Oncology Practice; 🇺🇸 Greer, South Carolina, United States

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States