Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- University of Utah
- Enrollment
- 358
- Locations
- 2
- Primary Endpoint
- Patient reported symptom levels
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Kathleen Mooney
Principal Investigator
University of Utah
Eligibility Criteria
Inclusion Criteria
- •Adult (age 18 or over)
- •Have a histological diagnosis of cancer
- •a life expectancy of at least 3 months and cognitively able to participate
- •Beginning a new course of chemotherapy that is planned for a minimum of 3 cycles;
- •care is under the direction of one of the 8 designated provider teams;
- •English speaking;
- •has access to a telephone on a daily basis and is able to use the phone unassisted as verified by the study staff during participant orientation.
Exclusion Criteria
- •patients who are receiving concurrent radiation therapy (as they would have daily contact with the health care system);
- •patients who see the provider team for recommendation of a chemotherapy regimen but treatment is then administered at a different site by other providers.
- •Patients receiving therapy agents that result in a drug related fever or therapy agents that are not anticipated to cause any of the 11 symptoms.
Outcomes
Primary Outcomes
Patient reported symptom levels
Time Frame: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
Secondary Outcomes
- Medical Encounters Telephone Interview(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(Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.)
- SF-36 Functional Status(Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.)
- Work interference(Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.)
- Work Limitations Questionnaire(Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.)