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A Pilot Study of Structured Palliative Care for Patients Enrolled on Phase I Clinical Trials

22. april 2019 opdateret af: Case Comprehensive Cancer Center
The goal of this research study is to find out if providing patients who are enrolled in phase 1 clinical trials with structured supportive care will enable them to continue in the Phase 1 trial longer and improve their quality of life by reducing or treating side effects and by providing emotional and social support to the patient and family. The structured supportive or palliative care intervention will be provided by a team of trained specialists which include doctors, nurses, social workers and spiritual care providers. The supportive care team will provide treatment to address symptoms, such as pain or anxiety, caused by the cancer itself or from the treatment. The team can make referrals to other specialists. Such as psychologists or nutritionist, if needed, and can help arrange for services to address home care needs.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Primary Objective(s): To assess symptoms, adverse events, duration on study, reason for study discontinuation, and quality of life among patients participating in phase I clinical trials who receive structured palliative care, and those who receive standard supportive care. Duration on study will serve as the primary objective for sample size determination.

Secondary Objective(s):

1. To describe the quantity (e.g. hours), type, and cost of palliative care personnel services used by patients and caregivers receiving structured palliative care.

Exploratory:

  1. To compare adverse event profiles, duration on study, and quality of life between patients who receive structured palliative care and those receiving standard supportive care.
  2. To compare caregiver burden and quality of life between the study arms.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

132

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44106
        • Case Comprehensive 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

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Patient Inclusion Criteria:

  • Patients must be enrolled in a Phase 1 clinical trial and be within 2 weeks of starting the experimental therapy or intervention.
  • Patients are eligible to enroll on this study with or without the enrollment of their caregiver.

Patient Exclusion Criteria:

  • Patients diagnosed with a hematologic malignancy.

Caregiver Inclusion Criteria:

  • Any caregiver is considered eligible for this study; The caregiver is the person identified by the patient as the one who provides the most regular physical and/or emotional support.
  • Caregivers must be willing to complete surveys at baseline and on monthly basis.

Caregiver Exclusion Criteria:

  • Caregivers who are solely professional, paid caregivers

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: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Standard Supportive Care
Adfærdsmæssigt: Standard supportive care
Supportive care for the patient and caregiver will be provided by the treating oncologist.
Eksperimentel: Structured Supportive Care
Adfærdsmæssigt: Structured palliative care
Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average total MSAS score
Tidsramme: Up to 6 months
Assessment of patient burden
Up to 6 months
Average total FACT-G score
Tidsramme: Up to 6 months
Measure patient quality of life
Up to 6 months
Reason for study discontinuation (Patient reported outcome)
Tidsramme: Up to 6 months
Measure of central tendency for why patients discontinued the phase I study. Patient reported outcomes for reason for study discontinuation will be qualitatively assessed
Up to 6 months
Duration on Study
Tidsramme: Up to 6 months
Measure of central tendency of the duration patients were on the phase I study. Duration on study will serve as the primary objective for sample size determination
Up to 6 months
Adverse events
Tidsramme: Up to 6 months
Measure of central tendency of adverse events. AE will be described and further categorized as modifiable (primary symptom experience) and non-modifiable (laboratory abnormalities). The influence of adverse events on study outcomes particularly duration on study and reason for study discontinuation will be assessed. An exploratory weighted adverse event score will be calculated using the equation: adverse event score = ∑ (NAE * GAE) where N denotes the adverse event number, G denotes grade, AE denotes adverse event. These scores will be compared between study arms
Up to 6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean number of hours of palliative care services
Tidsramme: Up to 6 months
Mean number of hours utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency
Up to 6 months
Type of palliative care services
Tidsramme: Up to 6 months
Measure of central tendency for the type of palliative care services utilized by patients and caregivers who received structured palliative care. This analysis will be descriptive, reporting measures of central tendency
Up to 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of adverse events of patients receiving structured and usual supportive care
Tidsramme: Up to 6 months
Up to 6 months
Average days on study
Tidsramme: Up to 6 months
Up to 6 months
Change in FACT-G score
Tidsramme: From baseline to last contact, up to 6 months
Change in patient symptom burden when compared to baseline between patients who received structured palliative care and those who received standard supportive care
From baseline to last contact, up to 6 months
Change in MSAS score
Tidsramme: From baseline to last contact, up to 6 months
Change in quality of life when compared to baseline between patients who received structured palliative care and those who received standard supportive care
From baseline to last contact, up to 6 months
Change in CRA score
Tidsramme: From baseline to last contact, up to 6 months
Change in caregiver burden when compared to baseline between those who received structured palliative care and those who received standard supportive care
From baseline to last contact, up to 6 months
Change in QOLLTI-F score
Tidsramme: From baseline to last contact, up to 6 months
Change in caregiver quality of life as assessed through change in QOLLTI-F score when compared to baseline between those who received structured palliative care and those who received standard supportive care
From baseline to last contact, up to 6 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Case Comprehensive Cancer Center

Efterforskere

  • Ledende efterforsker: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive 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.

Generelle publikationer

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

25. oktober 2015

Primær færdiggørelse (Faktiske)

10. januar 2019

Studieafslutning (Faktiske)

10. januar 2019

Datoer for studieregistrering

Først indsendt

4. september 2015

Først indsendt, der opfyldte QC-kriterier

4. september 2015

Først opslået (Skøn)

7. september 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. april 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. april 2019

Sidst verificeret

1. april 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • CASE5Y15

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Standard supportive care

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Sponsorer og samarbejdspartnere

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner