Trial Information

Improving Palliative Care for Patients With Cancer

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.