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Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00253383
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : December 19, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Study Description
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Brief Summary:

RATIONALE: Palliative care may help patients with advanced cancer live more comfortably.

PURPOSE: This randomized clinical trial is studying an early intervention palliative care program to see how well it works compared to a standard care program in improving end-of-life care in patients with advanced lung , gastrointestinal, genitourinary, or breast cancer.


Condition or disease Intervention/treatment Phase
Cancer Other: counseling intervention Other: educational intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Not Applicable

Detailed Description:

OBJECTIVES:

  • Determine the efficacy of an early intervention palliative care program comprising a phone-based nurse educator and shared medical appointments in improving end-of-life care of patients with advanced lung, gastrointestinal, genitourinary, or breast cancer.
  • Compare symptom management, quality of life, and the match between preference of care and the care received in patients treated with an early intervention palliative care program vs a standard care program.
  • Compare health care utilization by patients treated with these interventions.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to cancer diagnosis (lung vs breast vs gastrointestinal vs genitourinary) and participating center. Patients are randomized to 1 of 2 intervention arms.

  • Arm I (early-intervention palliative care program): Patients complete the Medical Care Questionnaire and receive a computer-generated prescription letter that outlines the problems they have identified; the patient's physician also receives a copy of the letter. Patients receive a series of phone calls weekly for 4 weeks and then at least monthly from a nurse educator. The phone calls address 3 major areas: coordination of palliative care options in the cancer center and the patient's community, including referrals for psychological or spiritual counseling, social work consultation, financial guidance, home health, palliative care or hospice services, and bereavement counseling for the family; problem-solving therapy, focusing on the identification of problems, definition of achievable goals, a plan for reaching those goals, and evaluation of success; and tailored psycho-educational modules from "Charting Your Course", covering end-of-life topics such as symptom management, advanced care planning, communication with the health care team and family members, spirituality, and nutrition. Patients also receive information regarding the purpose and time/location of symptom management, shared medical appointments (SMAs), which they can attend in person or call in to participate via speaker phone. SMAs are 1.5-hour monthly sessions conducted by a physician and a nurse practitioner that can accommodate 10-12 patients and their caregivers. The sessions include a welcome/social period, a question and answer/peer discussion, an interactive educational session, and an opportunity for one-on-one nurse practitioner appointments with a focus on a brief review of the patients' medical treatment plans.
  • Arm II (standard palliative care program): Patients receive standard palliative care from their physician/nurse practitioner team and have access to the palliative care nurse at the discretion of the treating physician.

Patients complete Functional Assessment of Chronic Illness Therapy-Palliative Care at baseline and every 3 months thereafter. Patients and caregivers complete surveys measuring their perception of the quality of the patient's cancer care at baseline and at 1 month.

A caregiver or family member completes the After-Death Bereaved Family Member Interview to evaluate the adequacy of patient care at 3 months post-patient death.

PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Improving Palliative Care for Patients With Cancer
Study Start Date : January 2003
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Palliative Care

Arms and Interventions
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Arm Intervention/treatment
Experimental: ENABLE (concurrent palliative care)
telephone based ENABLE educational intervention
 Other: counseling intervention
Other: educational intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Active Comparator: Usual Care
Supportive and palliative usual care services at DHMC, Behavioral
 Other: counseling intervention
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment


Outcome Measures
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Primary Outcome Measures :
  1. Quality of life as measured by Functional Assessment of Cancer Therapy-Palliative care version (FACT-Pal) at baseline, one month, and every three months thereafter [ Time Frame: Baseline, one month, every three months ]
  2. Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter [ Time Frame: Baseline, one month, every three months ]
  3. Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter [ Time Frame: Baseline, one month, every three months ]
  4. Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased [ Time Frame: Baseline, one month, every three months ]

Secondary Outcome Measures :
  1. Depression as measured by Center for Epidemiological Studies-Depression (CES-D) at baseline, one month, and every three months thereafter [ Time Frame: Baseline, one month, every three months ]
  2. Problem solving skills as measured by Social Problem-Solving Skills Inventory-revised at baseline and one month [ Time Frame: Baseline, one month, every three months ]
  3. Caregiver burden as measured by Montgomery-Borgatta Caregiver Burden Scale at baseline, one month, and every three months thereafter (given to caregivers of patients) [ Time Frame: Baseline, one month, every three months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following advanced cancers:

    • Stage IIIB or IV non-small cell lung cancer
    • Extensive stage small cell lung cancer

    • Stage IV breast cancer

      • Poor prognostic indicators (conferring likelihood of ≤ 2 years survival), including, but not limited to, any of the following:

        • Visceral crisis
        • Lung or liver metastasis
        • Estrogen receptor-negative disease
        • HER2/neu-positive disease
        • Progressive or recurrent disease during or within 2 years of first treatment
    • Unresectable stage III or stage IV gastrointestinal cancers

    • Stage IV genitourinary cancers

      • Prostate cancer must be hormone refractory

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Sex

  • Not specified

Menopausal status

  • Not specified

Performance status

  • Not specified

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

Other

  • No dementia or significant confusion (i.e., Mini Mental Exam score < 25)

  • No Axis I psychiatric disorders (DSM-IV), including any of the following:

    • Schizophrenia
    • Bipolar disorder
    • Active substance use disorder

PRIOR CONCURRENT THERAPY:

Endocrine therapy

  • See Disease Characteristics
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253383


Locations
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United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, Vermont
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States, 05009
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Marie A Bakitas, PhD Norris Cotton Cancer Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00253383    
Other Study ID Numbers: CDR0000452966
R01CA101704 ( U.S. NIH Grant/Contract )
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-0226
DMS-CPHS-16004
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by Dartmouth-Hitchcock Medical Center:
transitional care planning
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
stage IV breast cancer
recurrent breast cancer
male breast cancer
stage IIIB anal cancer
stage IV anal cancer
carcinoma of the appendix
stage III colon cancer
stage IV colon cancer
stage III rectal cancer
stage IV rectal cancer
stage III esophageal cancer
 stage IV esophageal cancer
unresectable extrahepatic bile duct cancer
unresectable gallbladder cancer
stage III gastric cancer
stage IV gastric cancer
metastatic gastrointestinal carcinoid tumor
regional gastrointestinal carcinoid tumor
gastrointestinal stromal tumor
advanced adult primary liver cancer
localized unresectable adult primary liver cancer
stage III pancreatic cancer
recurrent small intestine cancer
small intestine adenocarcinoma
small intestine leiomyosarcoma
small intestine lymphoma