Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System

Utah System of Higher Education (USHE)

Status: Completed

Conditions: Cancer

Treatments: Other: Provider Unrelieved Symptom Alert

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01979146

R01CA089474 (U.S. NIH Grant/Contract)

7846-00

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

Provider Unrelieved Symptom Alert

Experimental group

Description:

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.

Treatment:

Other: Provider Unrelieved Symptom Alert

Attentional Control Usual Care Group

No Intervention group

Description:

Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations. The usual care group received equivalent contact time with the automated system including identical voice and assessment questions. Data were not available for clinical action and not reported to the oncology providers. On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms.