Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
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|ClinicalTrials.gov Identifier: NCT01973946|
Recruitment Status : Completed
First Posted : November 1, 2013
Last Update Posted : March 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Symptom Alert and Coaching||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||358 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
No Intervention: Usual Care
Patients in the usual care group called the automated monitoring system daily to report presence, severity, and distress for 11 common symptoms. The attentional control group received equivalent contact time with the automated system including identical voice and assessment questions. Patients did not hear self-care messages during the call and the data were not available for clinical action by the study nurse practitioner. Patients were told on every phone call to call their oncology providers if they had concerns about their symptoms which is usual care for symptom follow up in oncology.
Experimental: 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.
Other: Symptom Alert and Coaching
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.
- 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.
- Medical Encounters Telephone Interview [ 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. ]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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
- Patient End of Study Telephone Interview [ Time Frame: 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. ]An End of Study Telephone Interview was conducted at the end of a patient's participation in the project to obtain data on patient satisfaction with the symptom monitoring system and to obtain suggestions for improvement of the system.
- Evaluation of automated and other self care strategies used and their effectiveness [ Time Frame: Weekly for an entire new course of chemotherapy or 6 months whichever occurred first. ]The symptom monitoring system tracked when an intervention participant heard a self care strategy during the course of the week. Each week patients would report on how helpful (1-10 scale) the automated self care measures were for the specific symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01973946
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232|
|United States, Utah|
|University of Utah Huntsman Cancer Institute|
|Salt Lake City, Utah, United States, 84132|
|Principal Investigator:||Kathleen H Mooney, PhD||University of Utah|