Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

28. Februar 2017 aktualisiert von: Kathleen Mooney, University of Utah

Telephone Linked Care: An IT Enabled Integrated System for Cancer Symptom Relief

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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

358

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Tennessee
      • Nashville, Tennessee, Vereinigte Staaten, 37232
        • Vanderbilt-Ingram Cancer Center
    • Utah
      • Salt Lake City, Utah, Vereinigte Staaten, 84132
        • University of Utah Huntsman Cancer Institute

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Kein Eingriff: 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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient reported symptom levels
Zeitfenster: 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.
Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Medical Encounters Telephone Interview
Zeitfenster: 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.
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
Zeitfenster: 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).
Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
SF-36 Functional Status
Zeitfenster: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
Functional status was measured monthly using the SF-36.
Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
Work interference
Zeitfenster: 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.
Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
Work Limitations Questionnaire
Zeitfenster: 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.
Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient End of Study Telephone Interview
Zeitfenster: 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.
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.
Evaluation of automated and other self care strategies used and their effectiveness
Zeitfenster: 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.
Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Utah

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Kathleen H Mooney, PhD, University of Utah

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2007

Primärer Abschluss (Tatsächlich)

1. April 2012

Studienabschluss (Tatsächlich)

1. April 2012

Studienanmeldedaten

Zuerst eingereicht

22. Oktober 2013

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Oktober 2013

Zuerst gepostet (Schätzen)

1. November 2013

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Februar 2017

Zuletzt verifiziert

1. Februar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 17472
  • 5R01CA120558 (US NIH Stipendium/Vertrag)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur Symptom Alert and Coaching

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in Canada

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

3
Abonnieren