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

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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

Tracking Information
First Submitted Date  ICMJE November 11, 2005
First Posted Date  ICMJE November 15, 2005
Last Update Posted Date December 19, 2014
Study Start Date  ICMJE January 2003
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00253383 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2013)
  • 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 ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients
Official Title  ICMJE Improving Palliative Care for Patients With Cancer
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Cancer
Intervention  ICMJE
  • Other: counseling intervention
  • Other: educational intervention
  • Procedure: psychosocial assessment and care
  • Procedure: quality-of-life assessment
Study Arms  ICMJE
  • Experimental: ENABLE (concurrent palliative care)
    telephone based ENABLE educational intervention
    Interventions:
    • 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
    Interventions:
    • Other: counseling intervention
    • Procedure: psychosocial assessment and care
    • Procedure: quality-of-life assessment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 18, 2014)
329
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00253383
Other Study ID Numbers  ICMJE CDR0000452966
R01CA101704 ( U.S. NIH Grant/Contract )
P30CA023108 ( U.S. NIH Grant/Contract )
DMS-0226
DMS-CPHS-16004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dartmouth-Hitchcock Medical Center
Study Sponsor  ICMJE Dartmouth-Hitchcock Medical Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Marie A Bakitas, PhD Norris Cotton Cancer Center
PRS Account Dartmouth-Hitchcock Medical Center
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP