The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns.
The purpose of this prospective trial is to test a daily telephone based automated symptom monitoring and response system to track and further treat unrelieved symptoms for patients living at home during chemotherapy treatment as compared with usual care which consists of patients calling their oncology provider for symptom concerns. For the intervention group, the monitoring system is paired with automated delivery of self-care suggestions tailored to the specific symptom profile the patient reported and also automatically 'alerts' the study oncology nurse practitioner about unrelieved symptoms. The nurse practitioner, utilizing national evidence based symptom guidelines for symptoms at moderate to severe levels calls the patient and further assesses and intensifies symptom treatment. The usual care group called the system daily and reported similar data but did not receive self-care coaching or notification of unrelieved symptoms to the study nurse practitioner. On every call, the usual care group was told to follow the standard procedure of calling their oncology providers for symptom concerns. The specific aims of the study are to test whether the symptom monitoring intervention reduces presence, severity and distress of 11 symptoms. The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, numbness \& tingling, diarrhea, trouble thinking, trouble sleeping, changes in appearance, depressed mood, anxiety, and fatigue. Secondary outcomes tested whether the intervention improved functional performance and decreased interference with activity when compared with the usual care attentional control group. Other aims compare self care strategies utilized and their perceived effectiveness and document patient satisfaction with the monitoring system.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
358
Patients heard self-care messages when they reported a symptom was present. The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily. The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
Patient reported symptom levels
During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
Time frame: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
Medical Encounters Telephone Interview
Each week patients reported during their daily phone calls whether or not they had been in contact with a health care provider, were seen in an emergency department or urgent care facility, or had an unscheduled hospitalization. If they reported they did have a medical encounter, the research staff would call and 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.
Time frame: Each week patients reported during the daily symptom monitoring call whether they had a medical encounter for an entire new course of chemotherapy or 6 months whichever occurred first.
Patient reported symptom related interference with daily activities
This is a one item question asked daily during the symptom monitoring call about the level of interference their symptoms had on their daily activities (0-10 scale).
Time frame: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
SF-36 Functional Status
Functional status was measured monthly using the SF-36.
Time frame: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
Work interference
For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
Time frame: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work Limitations Questionnaire
The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.
Time frame: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.