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

22 april 2019 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

132

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Ohio
      • Cleveland, Ohio, Verenigde Staten, 44106
        • Case Comprehensive Cancer Center

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard Supportive Care
Gedragsmatig: Standard supportive care
Supportive care for the patient and caregiver will be provided by the treating oncologist.
Experimenteel: Structured Supportive Care
Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Average total MSAS score
Tijdsspanne: Up to 6 months
Assessment of patient burden
Up to 6 months
Average total FACT-G score
Tijdsspanne: Up to 6 months
Measure patient quality of life
Up to 6 months
Reason for study discontinuation (Patient reported outcome)
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Mean number of hours of palliative care services
Tijdsspanne: 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
Tijdsspanne: 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

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Frequency of adverse events of patients receiving structured and usual supportive care
Tijdsspanne: Up to 6 months
Up to 6 months
Average days on study
Tijdsspanne: Up to 6 months
Up to 6 months
Change in FACT-G score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Case Comprehensive Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Michelle Treasure, MD, Metrohealth Medical Center and Case Comprehensive Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

25 oktober 2015

Primaire voltooiing (Werkelijk)

10 januari 2019

Studie voltooiing (Werkelijk)

10 januari 2019

Studieregistratiedata

Eerst ingediend

4 september 2015

Eerst ingediend dat voldeed aan de QC-criteria

4 september 2015

Eerst geplaatst (Schatting)

7 september 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

23 april 2019

Laatste update ingediend die voldeed aan QC-criteria

22 april 2019

Laatst geverifieerd

1 april 2019

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • CASE5Y15

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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