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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01245621
First received: November 15, 2010
Last updated: January 2, 2014
Last verified: October 2013
  Purpose

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.


Condition Intervention
Advanced Cancer
Behavioral: Later entry group
Behavioral: Early palliative care intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Outcomes

Resource links provided by NLM:


Further study details as provided by Dartmouth-Hitchcock Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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).

  • Quality of end of life care [ Time Frame: chart review at time of death and caregiver proxy interview 2-3 months after patient death ] [ Designated as safety issue: No ]

    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.


  • 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 ] [ Designated as safety issue: No ]
    We hypothesize that Early entry patients will have longer overall survival at one year compared with Later entry patients.

  • 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 ] [ Designated as safety issue: No ]

    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).


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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.


  • Determine feasibility of enrolling less common solid tumors and hematologic malignancies. [ Time Frame: Estimated recruitment period of 2 years ] [ Designated as safety issue: No ]
    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.

  • Explore patterns of stress (diurnal salivary and plasma cortisol) and immune biomarkers (lymphocyte subsets and cytokines) [ Time Frame: Baseline, 12, and 24 weeks ] [ Designated as safety issue: No ]

    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.


  • Examine the relations among quality of life, mood, symptoms, survival, stress and immune biomarkers. [ Time Frame: Baseline, 12, and 24 weeks ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 360
Study Start Date: October 2010
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245621

Locations
United States, New Hampshire
Dartmouth-Hitchcock Medical Center - Lebanon
Lebanon, New Hampshire, United States, 03756
Dartmouth-Hitchcock Clinic - Manchester
Manchester, New Hampshire, United States, 03102
Dartmouth-Hitchcock NCCC Nashua
Nashua, New Hampshire, United States, 03063
St. Joseph Hospital
Nashua, New Hampshire, United States, 03060
United States, Rhode Island
Providence VA Medical Center
Providence, Rhode Island, United States, 02908
United States, Vermont
Mountainview Medical
Berlin, Vermont, United States, 05061
Veteran's Administration Hospital
White River Junction, Vermont, United States, 05001
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Investigators
Principal Investigator: Marie A. Bakitas, DNSc, APRN Dartmouth-Hitchcock Medical Center
Study Director: Jennifer P. Frost, RN, MS Dartmouth-Hitchcock Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT01245621     History of Changes
Other Study ID Numbers: NCCC-BAKI: D0946, R01NR011871-01
Study First Received: November 15, 2010
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
palliative care
end of life care
quality of life
caregivers

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014