Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System

Cancer Clinical Trial

Official title:

Telephone Linked Care for Cancer Symptom Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01979146
• Other study ID #: 7846-00
• Secondary ID: R01CA089474
• Status: Completed
• Phase: N/A
• First received: October 22, 2013
• Last updated: February 28, 2017
• Start date: April 2001
• Est. completion date: March 2004

Study information

• Verified date: February 2017
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 2004
• Est. primary completion date: March 2004
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Provider Unrelieved Symptom Alert
The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale). The oncology providers used their clinical judgement in terms of what they did with the information received. There was no prescribed response as part of the intervention.

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient End of Study Telephone Interview	An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.	administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks
Other	Provider End of Study Interview	At the end of the study, participating providers were interviewed regarding the acceptability and use of the symptom alert reports and their suggestions for improvement.	Once, at the end of participation which is an expected average of 24 months
Primary	Patient reported symptom levels on a 0-10 scale	During daily automated calls, patients provided information about common chemotherapy symptoms.	patients report symptoms daily for the duration of the study, an expected average of 6 weeks
Secondary	Medical Encounters Telephone Interview	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.	participants will be followed for an expected average of 6 weeks
Secondary	Functional Status	The SF-12 was administered monthly to measure functional status.	monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
Secondary	Work Attendance	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.	reported daily, participants will be followed for an expected average of 6 weeks