Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Symptom Alert and Coaching

• Registration Number: NCT01973946
• Lead Sponsor: University of Utah

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.

Study Timeline

• Study Start: 2007-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2013-10-22
• Study First Submitted QC: 2013-10-25
• Study First Posted: 2013-11-01
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 358

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Symptom Alert and Coaching	Symptom Alert and Coaching	Patients in the Symptom Alert and Coaching arm called the automated monitoring system daily to report presence, severity, and distress on 11 symptoms. The system provided automated self care coaching based on the symptoms reported and automatically generated alerts to the study NP if symptoms exceeded preset thresholds. Two thresholds were set: a simple alert when severity or distress was 4 or greater on a 10 point scale and trend alerts based on a pattern of moderate severity over several days. The alerts went into a case management site. The study NP logged into the system daily and responded to the alerts within 24 hours by calling patients to further assess the symptoms and to intensify symptom treatment using evidence based guidelines.

Primary Outcome Measures

Name	Time	Method
Patient reported symptom levels	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 Outcome Measures

Name	Time	Method
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.	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.
Patient reported symptom related interference with daily activities	Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.	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).
SF-36 Functional Status	Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.	Functional status was measured monthly using the SF-36.
Work interference	Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.	For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
Work Limitations Questionnaire	Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.	The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.

Trial Locations

Locations (2)

Vanderbilt-Ingram Cancer Center; 🇺🇸 Nashville, Tennessee, United States

University of Utah Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States