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Clinical Trials/NCT01979146
NCT01979146
Completed
N/A

Telephone Linked Care for Cancer Symptom Management

University of Utah3 sites in 1 country250 target enrollmentApril 2001
ConditionsCancer

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cancer
Sponsor
University of Utah
Enrollment
250
Locations
3
Primary Endpoint
Patient reported symptom levels on a 0-10 scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2001
End Date
March 2004
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Kathleen Mooney

Principal Investigator

University of Utah

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

Patient reported symptom levels on a 0-10 scale

Time Frame: 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 Outcomes

  • Medical Encounters Telephone Interview(participants will be followed for an expected average of 6 weeks)
  • Work Attendance(reported daily, participants will be followed for an expected average of 6 weeks)
  • Functional Status(monthly for the duration of the study, participants will be followed for an expected average of 6 weeks)

Study Sites (3)

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