Cancer Symptom Monitoring Telephone System With Nurse Practitioner (NP) Follow up
28. února 2017 aktualizováno: 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.
Přehled studie
Detailní popis
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.
Typ studie
Intervenční
Zápis (Aktuální)
358
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Tennessee
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Nashville, Tennessee, Spojené státy, 37232
- Vanderbilt-Ingram Cancer Center
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Utah
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Salt Lake City, Utah, Spojené státy, 84132
- University of Utah Huntsman Cancer Institute
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Žádný zásah: 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.
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Experimentální: 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. |
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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Patient reported symptom levels
Časové okno: Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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During daily automated calls, patients provided information about common chemotherapy symptoms on a 0-10 scale.
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Daily patient reports of symptom levels were made for an entire new course of chemotherapy or 6 months whichever occurred first.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Medical Encounters Telephone Interview
Časové okno: 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.
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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.
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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.
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Patient reported symptom related interference with daily activities
Časové okno: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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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).
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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SF-36 Functional Status
Časové okno: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Functional status was measured monthly using the SF-36.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work interference
Časové okno: Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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For patients who indicated they worked during their treatment, the system asked daily if they missed work if it was a regular workday.
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Reported daily for an entire new course of chemotherapy or 6 months whichever occurred first.
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Work Limitations Questionnaire
Časové okno: Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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The 25 item patient-reported Work Limitations Questionnaire was used to measure work performance.
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Monthly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Patient End of Study Telephone Interview
Časové okno: 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.
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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.
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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.
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Evaluation of automated and other self care strategies used and their effectiveness
Časové okno: Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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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.
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Weekly for an entire new course of chemotherapy or 6 months whichever occurred first.
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Kathleen H Mooney, PhD, University of Utah
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. září 2007
Primární dokončení (Aktuální)
1. dubna 2012
Dokončení studie (Aktuální)
1. dubna 2012
Termíny zápisu do studia
První předloženo
22. října 2013
První předloženo, které splnilo kritéria kontroly kvality
25. října 2013
První zveřejněno (Odhad)
1. listopadu 2013
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. března 2017
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
28. února 2017
Naposledy ověřeno
1. února 2017
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- 17472
- 5R01CA120558 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
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