- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03671226
Præference for rumindstilling og ventetid hos patienter med avanceret, lokalt avanceret eller metastatisk kræft og deres plejere, der ses i det ambulante støttende/palliative center
Opfattelse af støttepatienter og pårørende, der ses i det ambulante støttende/palliative center med hensyn til præference for rumindstilling og ventetid
This trial studies the preference of room setting and waiting time in patients with cancer that has spread to nearby tissue or lymph nodes or other places in the body and their caregivers who are seen in the outpatient supportive/palliative care center. Room setting preferences of patients and caregivers may help to understand their opinion regarding direct rooming system in the outpatient supportive/palliative care center.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
PRIMARY OBJECTIVES:
I. To determine patients and caregivers preferences regarding the rooming process in outpatient supportive palliative care clinic, measured by the preference to exam room versus waiting area.
SECONDARY OBJECTIVES:
I. Patients and caregiver perceptions regarding room setting and waiting time in the outpatient supportive care clinic.
II. Extent/experience of team contact in the outpatient supportive care clinic. III. The factors associated with rooming preferences such as age, gender, symptom distress and performance status.
IV. The association between level of distress (physical, psychological, and spiritual distress as measured by Edmonton Symptom Assessment Scale (ESAS) and perception of usefulness of the visit to palliative care center.
V. The attitudes and beliefs toward usefulness of referral to outpatient palliative care.
VI. The correlation between the patient and caregivers preferences.
OUTLINE:
Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- M D Anderson Cancer Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Patient: Have advanced cancer, defined as locally advanced, metastatic or incurable disease.
- Patient: Seen at University of Texas M. D. Anderson Cancer Center (UTMDACC) outpatient Supportive Care Center for consultation (first visit).
- Patient: Provided informed consent.
- Patient: Can read and speak English or Spanish.
- Patient: Has a consenting caregiver at the time of the Supportive Care consultation visit.
- Caregiver: Provided informed consent.
- Caregiver: Can read and speak English or Spanish.
- Caregiver: Must be with consenting patient at the time of the Supportive Care consultation visit.
Exclusion Criteria:
- Patient: Delirium diagnosed by palliative care physician or nurse and/or Memorial Delirium Assessment Scale (MDAS) >= 7 or dementia.
- Patient: Inability to read and speak English or Spanish.
- Patient: No caregiver at the time of Supportive Care consultation visit.
- Caregiver: Inability to read and speak English or Spanish.
Studieplan
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 (questionnaire)
Patients and their caregivers complete a questionnaire over 15 minutes either in person or over the phone within 3 days after their supportive care center visit. |
Given questionnaire |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Preference of exam room over waiting room as soon as checking in until the nurse is ready for a patient assessed using questionnaire
Tidsramme: Up to 3 days after visit
|
Two sample t-test or Wilcoxon rank sum test, whichever more appropriate, will be used to compare continuous variables of interest between the preference of exam room over waiting area. Chi-squared test or Fisher's exact test, whichever appropriate, will be used to test for associations between each of categorical variables and preference of exam room over waiting area. Univariate/multicovariate logistic regression analysis will be used to explore the demographics and clinical factors associated with rooming preferences. |
Up to 3 days after visit
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: MarieBerta Vidal, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2018-0573
- 2018-0573 (Anden identifikator: M D Anderson Cancer Center)
- NCI-2018-01877 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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