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NCT Number: NCT00253383

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

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.

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Key information

Conditions

Cancer Adenocarcinoma Adnexal Diseases Anus Diseases Anus Neoplasms Appendiceal Neoplasms Breast Diseases Breast Neoplasms Breast Neoplasms, Male Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Cecal Diseases Cecal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Neoplasms Esophageal Diseases Esophageal Neoplasms Fallopian Tube Diseases Fallopian Tube Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Gastrointestinal Stromal Tumors Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male Gonadal Disorders Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Penile Diseases Penile Neoplasms Prostatic Diseases Prostatic Neoplasms Rectal Diseases Rectal Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Diseases Stomach Neoplasms Testicular Diseases Testicular Neoplasms Thoracic Neoplasms Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

Educational Intervention

Other

psychosocial assessment and care

Procedure

quality-of-life assessment

Procedure

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Improving Palliative Care for Patients With Cancer

Important dates

Study start
2003
Primary completion
2013
Study completion
2013
First posted
Nov 15, 2005
Registry last updated
Dec 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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