Clinical trial NCT01979146: Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
Official title: Telephone Linked Care for Cancer Symptom Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-11-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Patient reported symptom levels on a 0-10 scale
timeFrame: patients report symptoms daily for the duration of the study, an expected average of 6 weeks
Secondary outcomes:
measure: Medical Encounters Telephone Interview
timeFrame: participants will be followed for an expected average of 6 weeks
measure: Functional Status
timeFrame: monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
measure: Work Attendance
timeFrame: reported daily, participants will be followed for an expected average of 6 weeks
Other outcomes:
measure: Patient End of Study Telephone Interview
timeFrame: administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks
measure: Provider End of Study Interview
timeFrame: Once, at the end of participation which is an expected average of 24 months
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Greer
country: United States
facility: South Carolina Community Oncology Practice
state: South Carolina
city: Salt Lake City
country: United States
facility: University of Utah Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: University of Utah
name: Kathleen H Mooney, PhD
role: PRINCIPAL_INVESTIGATOR
References: