Nurse-Driven Telephone Intervention in Improving Side Effects in Cancer Patients Undergoing Chemotherapy
23. december 2019 opdateret af: M.D. Anderson Cancer Center
Evaluating the Feasibility of a Nurse-Driven Telephone Triage Intervention for Cancer Patients Undergoing Chemotherapy in the Ambulatory Setting
This clinical trial studies how well a nurse-driven telephone intervention improves side effects in patients with cancer who are undergoing chemotherapy.
Receiving calls from a nurse at home while receiving chemotherapy may improve the management of side effects and overall care in cancer patients.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
90
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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)
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
Hjælpestudier
Modtag telefonopkald
Complete survey
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Feasibility of completing nurse-driven telephone triage calls
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Symptom experience
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Colleen Jernigan, M.D. Anderson Cancer Center
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
17. oktober 2016
Primær færdiggørelse (Faktiske)
18. december 2019
Studieafslutning (Faktiske)
18. december 2019
Datoer for studieregistrering
Først indsendt
23. maj 2019
Først indsendt, der opfyldte QC-kriterier
23. maj 2019
Først opslået (Faktiske)
28. maj 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. december 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
23. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2016-0300 (Anden identifikator: M D Anderson Cancer Center)
- P30CA016672 (U.S. NIH-bevilling/kontrakt)
- NCI-2019-02651 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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