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Status:

COMPLETED

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

Lead Sponsor:

Dartmouth-Hitchcock Medical Center

Collaborating Sponsors:

National Institute of Nursing Research (NINR)

Conditions:

Advanced Cancer

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

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 stag...

Detailed Description

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, interdisciplinar...

Eligibility Criteria

Inclusion

  • INCLUSION CRITERIA FOR PATIENTS:
  • Able to speak and understand English
  • Over age 18
  • 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.
  • Estimated survival of 2 years or less
  • 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.
  • 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:
  • Able to read and understand English
  • Anyone identified by the patient as "a person who knows you well \& is involved in your medical care".
  • PATIENT EXCLUSION CRITERIA:
  • 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)
  • Axis I psychiatric diagnosis of severe mental illness (DSM-IV) (e.g. schizophrenia, bipolar disorder, or active substance use disorder)
  • Patients will not be excluded if they do not identify a caregiver
  • Prior involvement with palliative care service within the last year
  • Minimum predicted survival of less than 12 weeks (3 months)
  • PATIENT BIOMARKER SUBSTUDY EXCLUSION CRITERIA:
  • Receiving chronic steroid hormones or unable to schedule specimen collection distant from chemotherapy from steroid pre-medications
  • Unable to come to Norris Cotton Cancer Center (NCCC) for specimen collection times.
  • CAREGIVER EXCLUSION CRITERIA:
  • 1\. Unwilling to participate in study.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2010

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 1 2013

    Estimated Enrollment :

    360 Patients enrolled

    Trial Details

    Trial ID

    NCT01245621

    Start Date

    October 1 2010

    End Date

    September 1 2013

    Last Update

    January 3 2014

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    Dartmouth-Hitchcock Medical Center - Lebanon

    Lebanon, New Hampshire, United States, 03756

    2

    Dartmouth-Hitchcock Clinic - Manchester

    Manchester, New Hampshire, United States, 03102

    3

    St. Joseph Hospital

    Nashua, New Hampshire, United States, 03060

    4

    Dartmouth-Hitchcock NCCC Nashua

    Nashua, New Hampshire, United States, 03063