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Inbäddad palliativ vård i hantering av symtom hos deltagare med återkommande stadium III-IV thoraxmaligniteter och deras vårdgivare

1 oktober 2026 uppdaterad av: Carolyn Presley, Ohio State University Comprehensive Cancer Center

Inbäddad palliativ vård i hanteringen av avancerade torakala maligniteter

This trial studies how well embedded palliative care works in managing symptoms in participants with stage III-IV thoracic malignancies that has come back and their caregivers. Embedded palliative care may improve distress and anxiety in participants and caregivers.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. To determine feasibility of embedding a palliative care (PC) physician within the James Thoracic Oncology Clinic.

II. To assess patient and caregiver outcomes over a 12-month period within an embedded onco-palliative care clinic model.

III. To evaluate and describe clinician attitudes and beliefs regarding utilization of embedded palliative care as well as symptoms of provider burnout.

IV. To analyze health care utilization among participants receiving embedded onco-palliative care.

OUTLINE:

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.

After completion of study, patients are followed for up to 1 year.

Studietyp

Interventionell

Inskrivning (Faktisk)

68

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Ohio
      • Columbus, Ohio, Förenta staterna, 43210
        • Ohio State University Comprehensive Cancer Center

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patients with advanced or metastatic cancer of the chest (lung, thymus, or pleura): stage III or IV, recurrent disease
  • Patients will receive therapy (chemotherapy, immunotherapy, targeted therapy or radiation therapy) at The Ohio State University
  • New patients (defined as patients who have received no therapy for metastatic disease or have started treatment for metastatic disease within the last 30 days) or established patients with advanced cancer receiving anti-cancer therapy, no limit on prior therapies
  • Patient and caregiver must be able to read and understand consent form
  • Patients must designate a willing caregiver to participate although caregiver consent is not required for patient participation

Exclusion Criteria:

  • Patients who are already enrolled or have been previously enrolled in palliative care or hospice services as an outpatient. Inpatient palliative care consultation prior to enrollment is permitted
  • Patients who do not qualify for active anti-cancer therapy and opt to enroll in hospice services prior to study enrollment
  • Patients who are unable to read or understand consent form
  • Patients receiving primary systemic treatment outside of Ohio State. Outside radiation therapy is permitted

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Supportive care (embedded palliative care)

Participants and caregivers undergo embedded palliative care comprising symptom management (physical and psychological), advanced directives and goals of care discussion, caregiver support, and referral for adjunctive supportive services as needed at each clinic visit.
Övrig: Questionnaire Administration

Ancillary studies

Övrig: Palliative Therapy

Undergo embedded palliative care

Andra namn:
  • Symtomhantering
  • Comfort Care
  • Palliativ behandling
  • lindring
  • palliativ vård

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acceptance from providers to assess utilization of palliative care services
Tidsram: Up to 12 months

Acceptance will be evaluated utilizing provider surveys (to capture provider opinions on palliative care utilization) as well as rate of enrollment. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Up to 12 months
Demand of palliative care services to be evaluated
Tidsram: Up to 12 months

Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Up to 12 months
Capacity and productivity to be evaluated
Tidsram: Up to 12 months

Clinician capacity and productivity will be evaluated by looking at scheduling as well as billing productivity. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Up to 12 months
Resource assessment of staff and space
Tidsram: Up to 12 months

Resources required, including patient care rooms and nursing support will also be evaluated. Preliminary data will be summarized and collected. Confidence intervals will also be calculated for feasibility rates.
Up to 12 months
Symptom burden (patient outcome) supportive care screen
Tidsram: Up to 12 months

Will be assessed using Supportive care screen.
Up to 12 months
Symptom burden (patient outcome) Functional Assessment of Cancer Therapy-Lung
Tidsram: Up to 12 months

Will be assessed using Functional Assessment of Cancer Therapy-Lung
Up to 12 months
Symptom burden (patient outcome) using HADS
Tidsram: Up to 12 months

Will be assessed using Hospital Anxiety and Depression Scale (HADS)
Up to 12 months
Symptom burden using National Comprehensive Cancer Network distress thermometer (patient outcome)
Tidsram: Up to 12 months

Will be assessed using National Comprehensive Cancer Network distress thermometer
Up to 12 months
Anxiety assessment using Hospital Anxiety and Depression Scale (patient outcome)
Tidsram: Up to 12 months

Anxiety assessed using the Hospital Anxiety and Depression Scale
Up to 12 months
Depression assessment using Hospital Anxiety and Depression Scale (patient outcome)
Tidsram: Up to 12 months

Depression assessed using the Hospital Anxiety and Depression Scale
Up to 12 months
Functional status assessed using Functional Activities Scale (patient outcome)
Tidsram: Up to 12 months

Functional status assessment using Functional Activities Scale (FAS)
Up to 12 months
Health care service needs assessed using Supportive Care Needs Survey Partners and Caregivers (SCNS- P and C) (Caregiver outcome)
Tidsram: Up to 12 months

Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Up to 12 months
Psychological/emotional needs assessed using SCNS- P and C (Caregiver outcome)
Tidsram: Up to 12 months

Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Up to 12 months
Work/social needs assessed using SCNS- P and C (Caregiver outcome)
Tidsram: Up to 12 months

Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Up to 12 months
Information needs assessed using SCNS- P and C (Caregiver outcome)
Tidsram: Up to 12 months

Caregiver needs assessment using Supportive Care Needs Survey - Patients & Caregivers (SCNC-P&C)
Up to 12 months
Self-reported barriers and attitudes regarding palliative care assessed using Ohio State Palliative Care Provider Survey (Provider outcome)
Tidsram: Up to 12 months

Ohio State Palliative Care Provider survey used to assess perceived barriers to referral
Up to 12 months
Health care utilization outcomes
Tidsram: Up to 12 months

Will be captured using Integrated Health Information Systems electronic medical record data as well as patient reported events.
Up to 12 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Challenges for patients, caregivers, and the treating oncologist in an embedded palliative care model
Tidsram: Up to 12 months

evaluate the challenges for patients, caregivers and treating oncologist in embedded palliative care
Up to 12 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Ohio State University Comprehensive Cancer Center

Utredare

  • Huvudutredare: Carolyn Presley, MD, Ohio State University Comprehensive Cancer Center

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

12 december 2018

Primärt slutförande (Faktisk)

5 december 2019

Avslutad studie (Faktisk)

5 december 2020

Studieregistreringsdatum

Först inskickad

26 juni 2018

Först inskickad som uppfyllde QC-kriterierna

9 december 2020

Första postat (Faktisk)

10 december 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

6 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

1 oktober 2026

Senast verifierad

1 oktober 2023

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • OSU-18116
  • NCI-2018-01209 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))

Plan för individuella deltagardata (IPD)

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NEJ

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