Making Decisions About Participating in a Cancer Clinical Trial for Patients With Stage II, Stage III, or Stage IV Pancreatic Cancer or Stage III or Stage IV Colon Cancer or Rectal Cancer
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|ClinicalTrials.gov Identifier: NCT00478010|
Recruitment Status : Unknown
Verified August 2010 by Sidney Kimmel Comprehensive Cancer Center.
Recruitment status was: Active, not recruiting
First Posted : May 24, 2007
Last Update Posted : August 9, 2010
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 or disease||Intervention/treatment|
|Colorectal Cancer Pancreatic Cancer Psychosocial Effects of Cancer and Its Treatment||Other: counseling intervention Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- Determine the relationship between disease factors, patient factors, and understanding of the cancer clinical trial, and preferences for decision control in the decision to participate in a cancer clinical trial by patients with stage II-IV pancreatic cancer or stage III-IV colon or rectal cancer.
- Determine the relationship between disease factors, patient factors, understanding of the cancer clinical trial, and preferences for decision control with satisfaction with the decision to participate in a cancer clinical trial.
- Determine how quality of life, trust, and hope impact the decision to participate in a cancer clinical trial and the satisfaction with this decision.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Research Participation: Decision Making and Outcomes in Cancer Clinical Trials|
|Study Start Date :||January 2007|
|Estimated Primary Completion Date :||December 2008|
- Decision satisfaction
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00478010
|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|