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Sponsors and Collaborators: |
Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00478010 |
RATIONALE: Determining how patients makes decisions about participating in a clinical trial may help doctors plan clinical trials in which more patients are willing to participate and are satisfied with their decision to participate.
PURPOSE: This clinical trial is studying how patients with stage II, stage III, or stage IV pancreatic cancer or stage III or stage IV colon cancer or rectal cancer make decisions about participating in a clinical trial.
Condition | Intervention |
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Cancer-Related Problem/Condition Colorectal Cancer Pancreatic Cancer |
Other: counseling intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables |
Study Type: | Interventional |
Study Design: | Health Services Research, Open Label |
Official Title: | Research Participation: Decision Making and Outcomes in Cancer Clinical Trials |
Estimated Enrollment: | 200 |
Study Start Date: | January 2007 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: This is a cross-sectional study.
Patients complete 12 questionnaires to assess their symptom burden (e.g., nausea, pain, fatigue), sociodemographics, hope, quality of life, trust in the healthcare system, trust in health professionals, research decision control, perceived risks, adequacy of research information, clinical trial participation, and decision satisfaction.
PROJECTED ACCRUAL: A total of 200 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:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 |
Study Chair: | Barbara Biedrzycki | Sidney Kimmel Comprehensive Cancer Center |
Study ID Numbers: | CDR0000530879, JHOC-J0666, JHOC-NA_00003458 |
Study First Received: | May 23, 2007 |
Last Updated: | March 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00478010 History of Changes |
Health Authority: | United States: Federal Government |
psychosocial effects/treatment stage III colon cancer stage IV colon cancer stage III rectal cancer |
stage IV rectal cancer stage II pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Rectal Neoplasm Endocrine System Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Rectal Cancer Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Endocrinopathy Colorectal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Rectal Neoplasms Gastrointestinal Diseases Pancreatic Neoplasms Colonic Diseases Endocrine System Diseases Intestinal Diseases Rectal Diseases |
Intestinal Neoplasms Neoplasms Neoplasms by Site Digestive System Diseases Pancreatic Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Endocrine Gland Neoplasms |