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Palliativ vårdintervention för att förbättra symtomkontroll och livskvalitet hos patienter med stadium II-IV icke-småcellig lungcancer och deras familjevårdare

29 september 2026 uppdaterad av: City of Hope Medical Center

Översättning av en palliativ lungcancerintervention för klinisk praxis

This clinical trial studies a palliative care intervention in improving symptom control and quality of life in patients with stage II-IV non-small cell lung cancer and their family caregivers. Palliative care programs can provide patients and their caregivers with information on how to manage their symptoms, maintain health and well-being, and access supportive care services. An interdisciplinary palliative care model may effectively link lung cancer patients to the appropriate supportive care services in a timely fashion.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

PRIMARY OBJECTIVES:

I. Adapt a Palliative Care Intervention (PCI) tested in a National Cancer Institute (NCI) funded Program Project (P01) for dissemination to other oncology settings.

II. Determine the impact of the PCI on patient outcomes including symptom control, quality of life (QOL), and distress as compared to the usual care group.

III. Determine the impact of the PCI on family caregivers (FCG) outcomes including caregiver burden, caregiver distress, skills preparation and QOL as compared to the usual care group.

IV. Test the effects of the PCI on patient resource utilization as compared to the usual care group.

OUTLINE: Participants are enrolled sequentially to 1 of 2 phases.

PHASE I: Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.

PHASE II: Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.

In both groups, participants are followed up for 3 months.

Studietyp

Interventionell

Inskrivning (Faktisk)

361

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
    • California
      • Duarte, California, Förenta staterna, 91010
        • City of Hope Medical Center
      • Irvine, California, Förenta staterna, 92618
        • Southern California Permanente Medical Group
      • Ontario, California, Förenta staterna, 91761
        • Kaiser Permanente-Ontario Vineyard Medical Offices and Ambulatory SurgiCenter
      • Pasadena, California, Förenta staterna, 91101
        • Kaiser Permanente Department of Research and Evaluation
      • Riverside, California, Förenta staterna, 92505
        • Kaiser Permanente Medical 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:

Patient eligibility criteria for entry into the project include:

  • Diagnosis of stages II-IV non-small cell lung cancer (NSCLC)
  • Undergoing treatment with surgery, chemotherapy, radiation, or combined modalities
  • In Phase 2, subjects are also required on accrual to be referred to Palliative Care

FCG eligibility criteria include:

  • Designated by the patient as a person closely involved in their care
  • Age 18 years and older

All subjects must have the ability to understand and the willingness to sign a written informed consent

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: Icke-randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Phase I (usual care)

Participants receive usual care. This phase will aid in identifying usual care patterns in each site and provide an audit of system utilization as well as finalization of the educational materials for Phase II.
Övrig: questionnaire administration

Ancillary studies

Övrig: quality-of-life assessment

Ancillary studies

Andra namn:
  • livskvalitetsbedömning
Experimentell: Phase II (individualized palliative care)

Participants receive individualized palliative care comprised of tailored educational sessions designed for each patient and FCG that have been modified based on patterns observed in Phase I. The first patient teaching session will cover physical and psychological areas and the second will cover social and spiritual areas. These sessions will be completed within 2 weeks of accrual. A third teaching session is held with the FCG alone to give the FCG the opportunity to discuss their perspectives and focus on their needs. Patients will be asked to identify topics they want included and which if any should be omitted which provides for tailoring of the content to the patient's needs and preferences.
Övrig: questionnaire administration

Ancillary studies

Övrig: quality-of-life assessment

Ancillary studies

Andra namn:
  • livskvalitetsbedömning
Övrig: Palliative Therapy

Receive individualized palliative care

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Effekter av PCI på resursutnyttjandet jämfört med den vanliga vårdgruppen
Tidsram: Upp till 3 månader
Upp till 3 månader
Impact of the PCI on symptom control as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline symptom control scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on patient QOL as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on psychological distress as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline psychological distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on caregiver burden as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline caregiver burden scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on caregiver distress as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline caregiver distress scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on caregiver skills preparation as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline caregiver skills preparation scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months
Impact of the PCI on caregiver QOL as compared to the usual care group
Tidsram: Up to 3 months

The demographic and clinical characteristics as well as baseline caregiver QOL scores in the two phases will be compared. A repeated measures mixed model will be utilized for the three repeated measures (0, 1, and 3 months).
Up to 3 months

Samarbetspartners och utredare

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

Sponsor

City of Hope Medical Center

Samarbetspartners

National Cancer Institute (NCI)
National Institute of Nursing Research (NINR)

Utredare

  • Huvudutredare: Betty Ferrell, City of Hope Medical Center
  • Huvudutredare: Huong Nguyen, MD, Kaiser Permanente Department of Research and Evaluation

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.

Allmänna publikationer

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)

5 februari 2015

Primärt slutförande (Faktisk)

1 april 2019

Avslutad studie (Faktisk)

22 april 2019

Studieregistreringsdatum

Först inskickad

16 september 2014

Först inskickad som uppfyllde QC-kriterierna

16 september 2014

Första postat (Beräknad)

18 september 2014

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

2 oktober 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 14206
  • 14206 (Annan identifierare: City of Hope Medical Center)
  • NCI-2014-01926 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
  • 1R01NR015341-01 (U.S.S. NIH-anslag/kontrakt)

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