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A Primary Palliative Care Intervention for Patients With Advanced Cancer (CONNECT)

6 aprile 2021 aggiornato da: Yael Schenker, MD, MAS, University of Pittsburgh

A Cluster Randomized Trial of a Primary Palliative Care Intervention (CONNECT) for Patients With Advanced Cancer

The overall goal of this study is to test whether a nurse-led intervention to improve provision of primary palliative care within oncology practices (CONNECT) can decrease morbidity for patients with advanced cancer and their caregivers.

The specific aims are to:

Aim 1. Assess the effects of CONNECT on patient quality of life (primary outcome), symptom burden, and mood at 3-month follow-up.

Aim 2. Assess the effects of CONNECT on caregiver burden and mood at 3-month follow-up.

Aim 3. Assess the effects of CONNECT on healthcare resource use over 1 year of follow-up.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Study investigators will conduct a cluster randomized controlled trial comparing the CONNECT intervention to usual care in 16 oncology clinics. CONNECT (Care Management by Oncology Nurses to address supportive care needs) is a care management intervention using existing oncology nurses to improve provision of primary palliative care within outpatient oncology practices.

The study will enroll 672 patients with advanced cancer and their caregivers. The study will assess the intervention's impact on patient and caregiver quality-of-life and psychological outcomes at three months and on healthcare utilization through one year of follow up. Investigators will follow a rigorous plan to establish and maintain intervention fidelity. Detailed process information will be collected at all sites and the study will evaluate how CONNECT impacts mortality and costs.

Following best practices for complex system-level interventions, the study will use a cluster randomized trial design. The unit of randomization is the oncology practice, defined as a unique location and provider group for outpatient oncology care. The unit of analysis is the individual patient and caregiver.

Designated staff at each clinic will review oncologists' schedules on a weekly basis to identify and track potentially eligible patients with an upcoming appointment. Research staff will review tracking systems weekly to maintain recruitment fidelity. Identified patients will receive a 1-page study information sheet at their next clinic visit, followed by a detailed in-person explanation of the study from a trained staff member. This staff member will obtain informed consent from all participants. To minimize potential selection bias, participants will be told in advance of both groups and not randomized if they decline to be exposed to one of them.

To enhance retention, blinded research assistants will conduct monthly follow-up calls to assess healthcare utilization for participants in both groups. The data collection strategy is designed to minimize participant burden by using parsimonious measures previously pilot-tested with this population.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1290

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • UPMC Cancer Centers

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

21 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Participants will be (1) patients with advanced cancer receiving care at a participating clinic; (2) their caregivers; (3) their oncology staff nurses, oncologists, and practice managers.

Patient eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) the oncologist "would not be surprised if the patient died in the next year"; (3) Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤ 2; (4) planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.

Exclusion criteria: (1) Unable to read and respond to questions in English; (2) cognitive impairment or inability to consent to treatment, as determined by the patient's oncologist; (3) unable to complete baseline interview; (4) ECOG PS of 3 (capable of limited self-care; confined to bed or chair > 50% of waking hours) or 4 (cannot carry on any self-care; totally confined to bed or chair); (5) hematologic malignancy.

Caregiver eligibility criteria. Inclusion criteria: (1) adults (≥ 21 years old); (2) family member or friend of an eligible patient. Exclusion criteria: (1) unable to read and respond to questions in English; (2) unable to complete the baseline interview. Patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it.

Clinician eligibility criteria. Oncology staff nurses who undergo training to deploy CONNECT, oncologists, and practice managers at participating sites will be eligible to participate.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: CONNECT Intervention
At clinics randomized to the CONNECT intervention, oncology nurses will be selected by a nurse advisory panel to receive standardized primary palliative care training. A multi-step deployment strategy will be employed to orient oncologists and implement CONNECT processes. CONNECT nurses will administer CONNECT to enrolled patients and caregivers. An intervention fidelity monitoring and maintenance plan will be implemented to ensure high quality and consistent delivery of the intervention.
Comportamentale: CONNECT

Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals.

Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver.
Nessun intervento: Usual Care Control
At clinics randomized to Usual Care, enrolled patients and caregivers will continue to receive supportive oncology care according to usual practice.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Quality of Life - patient
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month FACIT-Pal scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Symptom burden - patient
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Edmonton Symptom Assessment Scale (ESAS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months
Depression and anxiety symptoms - patient
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months
Depression and anxiety symptoms - caregiver
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Hospital Anxiety and Depression Scale (HADS) scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.
Change from baseline to 3 months
Caregiver burden - caregiver
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Zarit Burden Interview-Short scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.
Change from baseline to 3 months
Healthcare Utilization
Lasso di tempo: 1 year
To inform future dissemination efforts and aid in understanding optimal financing models, the investigators will calculate implementation costs of the intervention and determine the effects of CONNECT on healthcare utilization, including hospitalizations, chemotherapy use, and hospice use.
1 year
Survival - patients
Lasso di tempo: 1 year
The investigators will calculate survival time from date of enrollment using the Kaplan-Meier method. We will use frailty models to assess for any effect of CONNECT on survival, controlling for the effects of clustering.
1 year

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient-Oncologist Therapeutic Relationship
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Human Connection Scale scores between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months
Hope - patients and caregivers
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month Herth Hope Index scores between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics.
Change from baseline to 3 months
Self-efficacy - patients and caregivers
Lasso di tempo: 3 months
The investigators will compare 3-month scores on the Cancer Behavior Inventory-Brief (patients) and the Caregiver Inventory (caregivers) between enrolled patients and caregivers at intervention clinics and enrolled patients and caregivers at usual care clinics.
3 months
Satisfaction - caregivers
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3-month FAMCARE-2 scores between enrolled caregivers at intervention clinics and enrolled caregivers at usual care clinics.
Change from baseline to 3 months
Distress - patients
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in the 3 months scores on the Distress Thermometer between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months
Illness understanding, care preferences, advance care planning - patients
Lasso di tempo: Change from baseline to 3 months
The investigators will compare change in patient illness understanding, care preferences, and advance care planning between enrolled patients at intervention clinics and enrolled patients at usual care clinics.
Change from baseline to 3 months
Burnout - clinicians
Lasso di tempo: Baseline and annually up to 60 months
The investigators will compare burnout (maslach burnout inventory) between clinicians at intervention clinics and usual care clinics.
Baseline and annually up to 60 months
Satisfaction with CONNECT and recommendations for improvement
Lasso di tempo: Annually up to 60 months
The investigators will assess satisfaction with CONNECT and recommendations for improvement among clinicians at intervention clinics annually.
Annually up to 60 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Pittsburgh

Collaboratori

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Yael Schenker, MD, MAS, University of Pittsburgh

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 luglio 2016

Completamento primario (Effettivo)

27 gennaio 2020

Completamento dello studio (Effettivo)

15 ottobre 2020

Date di iscrizione allo studio

Primo inviato

7 marzo 2016

Primo inviato che soddisfa i criteri di controllo qualità

14 marzo 2016

Primo Inserito (Stima)

18 marzo 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

8 aprile 2021

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 aprile 2021

Ultimo verificato

1 aprile 2021

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PRO15120154
  • 5R01CA197103-02 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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