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Study of Palliative Care Intervention for Advanced Cancer Patients and Their Caregivers -Educate Nurture Advise Before Life Ends (ENABLE III) (ENABLE III)

2 stycznia 2014 zaktualizowane przez: Dartmouth-Hitchcock Medical Center

Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes

ENABLE III is a randomized clinical trial that evaluates a phone-based palliative care intervention designed to improve quality of life, mood, and symptom management for patients with an advanced stage cancer and their caregivers.

The primary aims of this clinical trial are to determine whether a palliative care intervention (introduced immediately or 12 weeks after diagnosis) can improve survival, quality of life, mood, symptom intensity and end-of-life care.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. Palliative care strives to improve quality of life (QOL) and to prevent "bad deaths" by providing expert, interdisciplinary care to manage the effects of disease and treatment. Effective end-of-life (EOL) care depends upon proactive, patient-centered interventions to prepare patients and families for the challenges of terminal illness. We were able to demonstrate the feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention in improving quality of life and mood in our previous studies ENABLE I and ENABLE II; however, a number of gaps in our knowledge remain.

Patients will be randomized to begin the intervention either immediately or 12 weeks after a new diagnosis of advanced or recurrent cancer. This phone-based intervention consists of: 1) an Advanced Practice Palliative Care Nurse Interventionist instituting 1a) a 6-session manualized patient curriculum- Charting Your Course (CYC), 1b) a 3-session manualized, caregiver curriculum- the Creativity Optimism Planning Expert information (COPE) program, and 1c) on-going patient and caregiver follow up; and 2) Palliative Care Team Comprehensive Assessment & Management.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

360

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Stany Zjednoczone
    • New Hampshire
      • Lebanon, New Hampshire, Stany Zjednoczone, 03756
        • Dartmouth-Hitchcock Medical Center - Lebanon
      • Manchester, New Hampshire, Stany Zjednoczone, 03102
        • Dartmouth-Hitchcock Clinic - Manchester
      • Nashua, New Hampshire, Stany Zjednoczone, 03060
        • St. Joseph Hospital
      • Nashua, New Hampshire, Stany Zjednoczone, 03063
        • Dartmouth-Hitchcock NCCC Nashua
    • Rhode Island
      • Providence, Rhode Island, Stany Zjednoczone, 02908
        • Providence VA Medical Center
    • Vermont
      • Berlin, Vermont, Stany Zjednoczone, 05061
        • Mountainview Medical
      • White River Junction, Vermont, Stany Zjednoczone, 05001
        • Veteran's Administration Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

INCLUSION CRITERIA FOR PATIENTS:

  1. Able to speak and understand English
  2. Over age 18
  3. NEW diagnosis, recurrence, or progression of an advanced stage cancer within THIRTY days of the date the patient was informed of the diagnosis by his/her oncology clinician.
  4. Estimated survival of 2 years or less

  5. Diagnosed with an advanced stage cancer such as one of the following:

    • Lung Cancer: Stage IIIB or IV non-small cell, or extensive stage small cell
    • Breast Cancer: Stage IV with poor prognostic indicators including but not limited to: a) >2 cytotoxic regimens for MBC; b) diagnosis of MBC less then or equal to 12 months since completion of adjuvant or neoadjuvant treatment; c) triple negative disease (ER/PR - and Her 2-);d) parenchymal brain mets and/or carcinomatous meningitis
    • Gastrointestinal (GI) Cancers: Unresectable stage III or IV
    • Genitourinary (GU) Cancers: Stage IV (for prostate cancer inclusion is limited to persons with hormone refractory prostate cancer)
    • Brain Cancer: Unresectable, Grade IV
    • Melanoma, Stage IV
    • Hematologic Malignancies -Leukemia (e.g. acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL) - advanced stage, treatment refractory, poor prognosis cell type or chromosomal abnormalities, "older age" -Lymphoma- Stage IV or treatment refractory Hodgkin's disease or non-Hodgkin's lymphoma -Multiple Myeloma - elevated β2-microglobulin, albumin <3.5, PCLI >1%, CRP >6µg/mL, elevated LDH, plasmablastic morphology, abnormal. chromosome 13.
  6. Completion of baseline interview

INCLUSION CRITERIA FOR PATIENTS FOR BIOMARKER SUB-STUDY:

1. Only patients with lung, breast, GI, GU cancer are eligible

INCLUSION CRITERIA FOR CAREGIVERS:

  1. Able to read and understand English
  2. Anyone identified by the patient as "a person who knows you well & is involved in your medical care".

PATIENT EXCLUSION CRITERIA:

  1. Dementia or significant confusion (Impaired cognitive status as indicated by a score of 3 or less on the Callahan six-item cognitive screening tool 18)
  2. Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
  3. Patients will not be excluded if they do not identify a caregiver
  4. Prior involvement with palliative care service within the last year
  5. Minimum predicted survival of less than 12 weeks (3 months)

PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:

  1. Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications
  2. Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times.

CAREGIVER EXCLUSION CRITERIA:

1. Unwilling to participate in study.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Early entry group
Early entry group will begin the intervention at time of diagnosis of advanced cancer
Behawioralne: Early palliative care intervention
  1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert information(COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and
  2. Comprehensive Palliative Care Team Assessment & Management Plan.
Aktywny komparator: Later entry group
Later entry group will begin the intervention 12 weeks after enrollment in the study.
Behawioralne: Later entry group
  1. Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert Information (COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and
  2. Comprehensive Palliative Care Team Assessment & Management Plan.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change in patient's quality of living over time
Ramy czasowe: baseline, 6,12,18,24,36 and every 12 weeks until death or end of study

Quality of living assessments will include quality of life (QOL), mood, and symptom intensity measures using the following measures:

  • Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal):
  • Quality of Life at End of Life (QUAL-E).
  • Center for Epidemiological Study- Depression (CES-D).
baseline, 6,12,18,24,36 and every 12 weeks until death or end of study
Quality of end of life care
Ramy czasowe: chart review at time of death and caregiver proxy interview 2-3 months after patient death

End of life (EOL) Care Data Collection Form: This form is used to collect information about the quality of EOL care and circumstances surrounding the last 48 hours of life for patients who die in hospital, nursing home, or home.

Quality of Dying and Death Measure (QODD). The QODD is a structured interview conducted with a caregiver to measure the quality of a patient's last week of life. The interview assesses the caregiver's perception of patient symptoms, preferences, and satisfaction with care.
chart review at time of death and caregiver proxy interview 2-3 months after patient death
Estimate and compare the hazard ratios and median survival before and after 1 year from enrollment
Ramy czasowe: From enrollment until patient death or end of study
We hypothesize that Early entry patients will have longer overall survival at one year compared with Later entry patients.
From enrollment until patient death or end of study
Change in caregiver quality of life, burden and grief over time
Ramy czasowe: baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study

Caregiver burden and QOL will be measured using:

  • Quality of Life- Cancer- a self-report measure of QOL for caregivers of patients with cancer.
  • Montgomery Borgatta Caregiver Burden Scale -a self-report measure of caregiver burden.
  • Center for Epidemiological Study- Depression CESD is a measure of depressive symptoms.
  • Functional Assessment of Chronic Illness Therapy - Spiritual Module (FACIT-Sp) - a measure of spiritual well-being developed for persons with chronic illness.
  • Prigerson Inventory of Complicated Grief-Short form (ICG-SF) embedded in the Quality of Death and Dying (QODD).
baseline, 6,12,18,24,36, and every 12 weeks until patient death or end of study

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Mediating mechanisms and moderators of the concurrent palliative care intervention.
Ramy czasowe: baseline, 6,12,18,24,36 weeks and every 12 weeks until death or end of study

Mediating mechanisms measured will include patient activation, decision support, goal setting, problem solving, care coordination.

Moderators measures will include: decision control and treatment goals, self-efficacy, optimism, coping style, social support.
baseline, 6,12,18,24,36 weeks and every 12 weeks until death or end of study
Determine feasibility of enrolling less common solid tumors and hematologic malignancies.
Ramy czasowe: Estimated recruitment period of 2 years
ENABLE II recruited patients only with lung, breast, GI, and GU tumors. We will attempt to also recruit patients with less common "poor prognosis" solid tumors (e.g. brain) and hematologic malignancies and their caregivers for this concurrent oncology palliative care intervention.
Estimated recruitment period of 2 years
Explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines)
Ramy czasowe: Baseline, 12, and 24 weeks

We will explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines)at baseline, 12, and 24 weeks after intervention in a subset of 50 patients with breast, lung, GI, and GU cancer.

We hypothesize that stabilized or improved biomarkers of stress and immune function will be evident after Early and Later entry intervention participation.
Baseline, 12, and 24 weeks
Examine the relations among quality of life, mood, symptoms, survival, stress and immune biomarkers.
Ramy czasowe: Baseline, 12, and 24 weeks
We hypothesize that higher quality of life,mood, lower symptom intensity, and longer survival will be associated with stable or improved stress and immune biomarkers (e.g. normal plasma cortisol and diurnal salivary cortisol variability, lymphocyte subsets and cytokines
Baseline, 12, and 24 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Dartmouth-Hitchcock Medical Center

Współpracownicy

National Institute of Nursing Research (NINR)

Śledczy

  • Główny śledczy: Marie A. Bakitas, DNSc, APRN, Dartmouth-Hitchcock Medical Center
  • Dyrektor Studium: Jennifer P. Frost, RN, MS, Dartmouth-Hitchcock Medical Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2010

Zakończenie podstawowe (Rzeczywisty)

1 września 2013

Ukończenie studiów (Rzeczywisty)

1 września 2013

Daty rejestracji na studia

Pierwszy przesłany

15 listopada 2010

Pierwszy przesłany, który spełnia kryteria kontroli jakości

19 listopada 2010

Pierwszy wysłany (Oszacować)

22 listopada 2010

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

3 stycznia 2014

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

2 stycznia 2014

Ostatnia weryfikacja

1 października 2013

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NCCC-BAKI: D0946
  • R01NR011871-01 (Grant/umowa NIH USA)

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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