Cancer & Chemotherapy Symptom Management Using an Automated Telephone Reporting System
28 février 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Réel)
250
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02118
- Boston Medical Center
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South Carolina
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Greer, South Carolina, États-Unis, 29650
- South Carolina Community Oncology Practice
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Utah
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Salt Lake City, Utah, États-Unis, 84112
- University of Utah Huntsman Cancer Institute
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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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Aucune intervention: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient reported symptom levels on a 0-10 scale
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Medical Encounters Telephone Interview
Délai: 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
Délai: 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
Délai: 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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Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Patient End of Study Telephone Interview
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Kathleen H Mooney, PhD, University of Utah
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 avril 2001
Achèvement primaire (Réel)
1 mars 2004
Achèvement de l'étude (Réel)
1 mars 2004
Dates d'inscription aux études
Première soumission
22 octobre 2013
Première soumission répondant aux critères de contrôle qualité
1 novembre 2013
Première publication (Estimation)
8 novembre 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
1 mars 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
28 février 2017
Dernière vérification
1 février 2017
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 7846-00
- R01CA089474 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
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