Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
28. februar 2017 oppdatert av: Kathleen Mooney, University of Utah
Telephone Linked Care for Cancer Symptom Management
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
Studieoversikt
Detaljert beskrivelse
The purpose of this study was to test the efficacy of a computer-based automated symptom monitoring telephone system used by patients who received chemotherapy for their cancer to communicate unrelieved symptoms they experienced to their oncology providers.
The symptoms monitored in the project were nausea/vomiting, pain, sore mouth, diarrhea, constipation, depressed mood, anxiety, trouble sleeping, and fatigue.
The study randomly assigned participants into either the intervention group or the group that received usual care from their oncology providers without alert notifications.
All participants called the automated system daily to report their symptom presence, severity, and distress.
When participants in the intervention group rated symptoms at moderate (4-7) to severe (8-10) levels an e-mail alert report of their symptom information was sent to the participant's medical oncologist and oncology nurse.
The usual care group also reported symptoms daily to the automated system but their information was not sent to the providers.
Participants in the usual care group were told daily to call their oncology provider if they had concerns about their symptoms.
The two study groups were compared over chemotherapy cycles 2 and 3 on symptom presence, severity, and distress.
Functional status, patient reported degree of symptom interference with normal activities, and work attendance if they had indicated that they worked during their treatment were also recorded.
In addition, the groups were compared for the number and purpose of unscheduled patient-provider contacts, visits to the emergency department or urgent care facility, and unscheduled hospitalizations.
Studietype
Intervensjonell
Registrering (Faktiske)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Massachusetts
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Boston, Massachusetts, Forente stater, 02118
- Boston Medical Center
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South Carolina
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Greer, South Carolina, Forente stater, 29650
- South Carolina Community Oncology Practice
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Utah
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Salt Lake City, Utah, Forente stater, 84112
- University of Utah Huntsman Cancer Institute
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Adult (18 or older)
- Histological Diagnosis of Cancer
- Life Expectancy of at least 6 months
- Cognitively able to participate (verified by provider team)
- Initiated a course of new Chemotherapy that is planned for a minimum of 3 cycles
- Had Poorly controlled symptoms during the first cycle of chemotherapy
- Care under the direction of one of the designated provider teams
- English or Spanish speaking
- Has access to a telephone on a daily basis
- Able to use the telephone unassisted
Exclusion Criteria:
- Receiving concurrent radiation therapy because they would be in daily contact with oncology care providers.
- Patients seeing the provider team for recommendation of chemotherapy regimen but other providers then administer treatment at different site
- Patients receiving a treatment regimen with only biotherapy agents or agents not associated with the symptoms monitored
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Provider Unrelieved Symptom Alert
Patients in the intervention arm called the automated monitoring system daily to report presence, severity and distress on a 1-10 scale for nine symptoms.
The system immediately sent an emailed symptom alert report to their oncologist and oncology nurse if symptoms exceeded preset thresholds (moderate to severe levels).
Two thresholds were set: a simple alert when severity or distress was 4 or greater on the 10 point scale and trend alerts based on a pattern of moderate severity over several days.
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The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale).
The oncology providers used their clinical judgement in terms of what they did with the information received.
There was no prescribed response as part of the intervention.
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Ingen inngripen: Attentional Control Usual Care Group
Patients in the usual care group called the automated monitoring system daily to report presence, severity and distress (1-10 scale) on 9 symptoms and also measured symptom interference with daily activities, functional status, work attendance, and unscheduled provider visits, urgent care and emergency department visits, and unscheduled hospitalizations.
The usual care group received equivalent contact time with the automated system including identical voice and assessment questions.
Data were not available for clinical action and not reported to the oncology providers.
On every call, usual care participants were reminded to call their oncology provider if they had symptom concerns, which is the usual practice in oncology settings to address unrelieved symptoms.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient reported symptom levels on a 0-10 scale
Tidsramme: patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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During daily automated calls, patients provided information about common chemotherapy symptoms.
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patients report symptoms daily for the duration of the study, an expected average of 6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Medical Encounters Telephone Interview
Tidsramme: participants will be followed for an expected average of 6 weeks
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When a patient reports during their daily phone call with the automated symptom monitoring system that they had been in contact with a health care provider, the research staff would 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 by the system.
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participants will be followed for an expected average of 6 weeks
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Functional Status
Tidsramme: monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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The SF-12 was administered monthly to measure functional status.
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monthly for the duration of the study, participants will be followed for an expected average of 6 weeks
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Work Attendance
Tidsramme: reported daily, participants will be followed for an expected average of 6 weeks
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Patients who indicated at study enrollment that they planned to work during treatment answered a yes/no question during the automated symptom monitoring system call to report whether or not they worked the previous day.
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reported daily, participants will be followed for an expected average of 6 weeks
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient End of Study Telephone Interview
Tidsramme: administered at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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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 at the end of participation in the study, participants will be followed for an expected average of 6 weeks
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Provider End of Study Interview
Tidsramme: Once, at the end of participation which is an expected average of 24 months
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At the end of the study, participating providers were interviewed regarding the acceptability and use of the symptom alert reports and their suggestions for improvement.
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Once, at the end of participation which is an expected average of 24 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Kathleen H Mooney, PhD, University of Utah
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2001
Primær fullføring (Faktiske)
1. mars 2004
Studiet fullført (Faktiske)
1. mars 2004
Datoer for studieregistrering
Først innsendt
22. oktober 2013
Først innsendt som oppfylte QC-kriteriene
1. november 2013
Først lagt ut (Anslag)
8. november 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
1. mars 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
28. februar 2017
Sist bekreftet
1. februar 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 7846-00
- R01CA089474 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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