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Sponsors and Collaborators: |
Norris Cotton Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00253383 |
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.
Condition | Intervention |
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Cancer |
Procedure: counseling Procedure: educational intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment |
Study Type: | Interventional |
Study Design: | Randomized |
Official Title: | Improving Palliative Care for Patients With Cancer |
Estimated Enrollment: | 450 |
Study Start Date: | January 2003 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following advanced cancers:
Stage IV breast cancer
Poor prognostic indicators (conferring likelihood of ≤ 2 years survival), including, but not limited to, any of the following:
Stage IV genitourinary cancers
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
No Axis I psychiatric disorders (DSM-IV), including any of the following:
PRIOR CONCURRENT THERAPY:
Endocrine therapy
United States, New Hampshire | |
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756-0002 | |
United States, Vermont | |
Veterans Affairs Medical Center - White River Junction | |
White River Junction, Vermont, United States, 05009 |
Investigator: | Kathleen Lyons, ScD | Norris Cotton Cancer Center |
Study ID Numbers: | CDR0000452966, DMS-0226, DMS-CPHS-16004 |
Study First Received: | November 11, 2005 |
Last Updated: | November 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00253383 |
Health Authority: | United States: Federal Government |
quality of life 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 |
Neuroectodermal Tumors, Primitive Rectal Neoplasms Pancreatic Neoplasms Malignant mesenchymal tumor Lung Neoplasms Neuroepithelioma Rectal cancer Breast Diseases Non-small cell lung cancer Urinary Bladder Neoplasms Breast Neoplasms Sarcoma, Clear Cell Stomach cancer Renal cancer Testicular Neoplasms |
Gall bladder cancer Rhabdoid tumor Carcinoma Carcinoma, Small Cell Neuroectodermal Tumors Urethral cancer Breast Neoplasms, Male Sarcoma Testicular cancer Carcinoid Tumor Gallbladder Neoplasms Esophageal Diseases Anus Neoplasms Prostatic Neoplasms Carcinoma, Non-Small-Cell Lung |
Neoplasms Neoplasms by Site |