Clinical trial NCT01973946: Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
Official title: Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
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: 2013-11-01
Enrollment: 358
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 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.

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.

Primary outcomes:
measure: Patient reported symptom levels
timeFrame: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
Secondary outcomes:
measure: Medical Encounters Telephone Interview
timeFrame: 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.
measure: Patient reported symptom related interference with daily activities
timeFrame: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
measure: SF-36 Functional Status
timeFrame: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
measure: Work interference
timeFrame: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
measure: Work Limitations Questionnaire
timeFrame: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
Other outcomes:
measure: Patient End of Study Telephone Interview
timeFrame: Administered once, at the end of the patients' participation in the study which was following an entire new course of chemotherapy or 6 months whichever occurred first.
measure: Evaluation of automated and other self care strategies used and their effectiveness
timeFrame: Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
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:
citation: Mooney KH, Beck SL, Wong B, Dunson W, Wujcik D, Whisenant M, Donaldson G. Automated home monitoring and management of patient-reported symptoms during chemotherapy: results of the symptom care at home RCT. Cancer Med. 2017 Mar;6(3):537-546. doi: 10.1002/cam4.1002. Epub 2017 Jan 30.