- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT03964896
Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy
Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
PRIMARY OBJECTIVES:
I. To explore the feasibility of a proactive nurse-driven telephone triage intervention for patients with cancer receiving first-line chemotherapy in the ambulatory setting.
SECONDARY OBJECTIVES:
I. To explore the symptom experience of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
II. To explore the satisfaction of patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
III. To explore the frequency of emergency room visits and hospital admissions for symptom management by patients receiving a nurse-driven telephone triage intervention while receiving chemotherapy in the ambulatory setting.
OUTLINE:
During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Texas
-
Houston, Texas, Vereinigte Staaten, 77030
- M D Anderson Cancer Center
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- English speaking
- Newly diagnosed patients with a breast, sarcoma, or head and neck cancer diagnosis preparing to undergo first-line, standard of care chemotherapy (patients with head and neck cancer may be undergoing concurrent first-line chemotherapy and radiation treatment)
- All chemotherapy treatment to be completed at the study institution
Exclusion Criteria:
- Patients who have received previous chemotherapy treatment for cancer
- Patients who will be receiving chemotherapy on research protocols
- Pregnant patients, as they may be on unique treatment protocols outside standard of care or have symptom needs that are beyond the scope of this intervention
- Patients who are unable to verbalize (e.g. due to tracheostomy)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: Supportive Care (telephone intervention)
During standard of care chemotherapy, patients receive up to 18 telephone calls from a nurse using a standardized triage call script over 20 minutes.
|
Nebenstudien
Telefonanrufe entgegennehmen
Complete survey
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Feasibility of completing nurse-driven telephone triage calls
Zeitfenster: Up to 25 weeks
|
Completion is defined as the patient answering the call and completing the assessment; the target completion rate is set as 70%.
Completion of nurse-driven calls will be assessed separately by center (breast, sarcoma, head and neck) and globally across all centers.
The study will declare the intervention to be feasible within a center if the 90% confidence interval for completion rate is completely above 70% or contains 70%.
To calculate the confidence interval, the study will construct a generalized linear mixed model with only a term for intercept.
|
Up to 25 weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Symptom experience
Zeitfenster: Up to 25 weeks
|
Will be measured using the MD Anderson Symptom Inventory (MDASI).
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
The MDASI will be assessed by center and time point, as well as by time point across all centers.
|
Up to 25 weeks
|
Patient Satisfaction
Zeitfenster: Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Satisfaction will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
Number of emergency room visits
Zeitfenster: Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Number of emergency room visits will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
Number of hospital admissions
Zeitfenster: Up to 25 weeks
|
This information will be summarized using graphical methods including box-plots and histograms, as well as summary statistics and 90% confidence intervals.
Number of hospital admissions will be assessed by treatment group and by time point, as appropriate.
They will also be assessed by center and again across all centers.
|
Up to 25 weeks
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Colleen Jernigan, M.D. Anderson Cancer Center
Publikationen und hilfreiche Links
Nützliche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2016-0300 (Andere Kennung: M D Anderson Cancer Center)
- P30CA016672 (US NIH Stipendium/Vertrag)
- NCI-2019-02651 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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 .
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