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Improving Palliative Care for Patients With Cancer

18 Years
Open (Enrolling)

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Trial Information

Improving Palliative Care for Patients With Cancer


- 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.

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

- Unresectable stage III or stage IV gastrointestinal cancers

- Stage IV genitourinary cancers

- Prostate cancer must be hormone refractory

- Hormone receptor status:

- Not specified



- Not specified

Menopausal status

- Not specified

Performance status

- Not specified

Life expectancy

- Not specified


- Not specified


- Not specified


- Not specified


- 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


Endocrine therapy

- See Disease Characteristics

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

Baseline, one month, every three months

Safety Issue:


Principal Investigator

Marie A Bakitas, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Norris Cotton Cancer Center


United States: Federal Government

Study ID:




Start Date:

January 2003

Completion Date:

Related Keywords:

  • Cancer
  • 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
  • stage IV bladder cancer
  • stage IV renal cell cancer
  • clear cell sarcoma of the kidney
  • peripheral primitive neuroectodermal tumor of the kidney
  • rhabdoid tumor of the kidney
  • metastatic transitional cell cancer of the renal pelvis and ureter
  • anterior urethral cancer
  • posterior urethral cancer
  • urethral cancer associated with invasive bladder cancer
  • stage IV penile cancer
  • stage IV prostate cancer
  • stage III malignant testicular germ cell tumor
  • stage IV endometrial carcinoma
  • fallopian tube cancer
  • ovarian sarcoma
  • ovarian stromal cancer
  • stage IV pancreatic cancer



Veterans Affairs Medical Center - White River Junction White River Junction, Vermont  05009
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002