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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathleen Mooney, University of Utah

Tracking Information
First Submitted Date  ICMJE October 22, 2013
First Posted Date  ICMJE November 1, 2013
Last Update Posted Date March 1, 2017
Study Start Date  ICMJE September 2007
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01973946 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2013)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 25, 2013)
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
Official Title  ICMJE Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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.

    Intervention: Other: Symptom Alert and Coaching
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2013)
358
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2012
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01973946
Other Study ID Numbers  ICMJE 17472
5R01CA120558 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathleen Mooney, University of Utah
Study Sponsor  ICMJE University of Utah
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Kathleen H Mooney, PhD University of Utah
PRS Account University of Utah
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP