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

January 2, 2014 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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, 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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Early entry group
Early entry group will begin the intervention at time of diagnosis of advanced cancer
Behavioral: 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.
Active Comparator: Later entry group
Later entry group will begin the intervention 12 weeks after enrollment in the study.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in patient's quality of living over time
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mediating mechanisms and moderators of the concurrent palliative care intervention.
Time Frame: 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.
Time Frame: 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)
Time Frame: 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.
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dartmouth-Hitchcock Medical Center

Collaborators

National Institute of Nursing Research (NINR)

Investigators

  • Principal Investigator: Marie A. Bakitas, DNSc, APRN, Dartmouth-Hitchcock Medical Center
  • Study Director: Jennifer P. Frost, RN, MS, Dartmouth-Hitchcock Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

November 15, 2010

First Submitted That Met QC Criteria

November 19, 2010

First Posted (Estimate)

November 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCCC-BAKI: D0946
  • R01NR011871-01 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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