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

Cancer Clinical Trial

Official title:

Improving Palliative Care for Patients With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00253383
• Other study ID #: CDR0000452966
• Secondary ID: R01CA101704P30CA
• Status: Completed
• Phase: N/A
• First received: November 11, 2005
• Last updated: December 18, 2014
• Start date: January 2003
• Est. completion date: September 2013

Study information

• Verified date: December 2014
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• counseling intervention

• educational intervention

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 tria — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Baseline, one month, every three months	No
Primary	Symptom management as measured by Edmunton Symptom Assessment Scale at baseline, one month, and every three months thereafter		Baseline, one month, every three months	No
Primary	Health care utilization by a chart review of days in hospital, ICU, ER visits at baseline, one month, and every three months thereafter		Baseline, one month, every three months	No
Primary	Correlate preferences for care and care received as measured by After Death Bereaved Family Member Interview with a family member of the deceased		Baseline, one month, every three months	No
Secondary	Depression as measured by Center for Epidemiological Studies-Depression (CES-D) at baseline, one month, and every three months thereafter		Baseline, one month, every three months	No
Secondary	Problem solving skills as measured by Social Problem-Solving Skills Inventory-revised at baseline and one month		Baseline, one month, every three months	No
Secondary	Caregiver burden as measured by Montgomery-Borgatta Caregiver Burden Scale at baseline, one month, and every three months thereafter (given to caregivers of patients)		Baseline, one month, every three months	No