Early Intervention vs. Standard Palliative Care in Improving End-of-Life Care in Advanced Cancer Patients
NCT ID: NCT00253383
Last Updated: 2014-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
329 participants
INTERVENTIONAL
2003-01-31
2013-09-30
Brief Summary
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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
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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ENABLE (concurrent palliative care)
telephone based ENABLE educational intervention
counseling intervention
educational intervention
psychosocial assessment and care
quality-of-life assessment
Usual Care
Supportive and palliative usual care services at DHMC, Behavioral
counseling intervention
psychosocial assessment and care
quality-of-life assessment
Interventions
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counseling intervention
educational intervention
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marie A Bakitas, PhD
Role: PRINCIPAL_INVESTIGATOR
Norris Cotton Cancer Center
Locations
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Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Veterans Affairs Medical Center - White River Junction
White River Junction, Vermont, United States
Countries
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References
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Bakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA. Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. JAMA. 2009 Aug 19;302(7):741-9. doi: 10.1001/jama.2009.1198.
Corn BW, Feldman DB, Hull JG, O'Rourke MA, Bakitas MA. Dispositional hope as a potential outcome parameter among patients with advanced malignancy: An analysis of the ENABLE database. Cancer. 2022 Jan 15;128(2):401-409. doi: 10.1002/cncr.33907. Epub 2021 Oct 6.
Prescott AT, Hull JG, Dionne-Odom JN, Tosteson TD, Lyons KD, Li Z, Li Z, Dragnev KH, Hegel MT, Steinhauser KE, Ahles TA, Bakitas MA. The role of a palliative care intervention in moderating the relationship between depression and survival among individuals with advanced cancer. Health Psychol. 2017 Dec;36(12):1140-1146. doi: 10.1037/hea0000544. Epub 2017 Oct 19.
Other Identifiers
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DMS-0226
Identifier Type: -
Identifier Source: secondary_id
DMS-CPHS-16004
Identifier Type: -
Identifier Source: secondary_id
CDR0000452966
Identifier Type: -
Identifier Source: org_study_id