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
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.
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
|Study Design:||Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Research Participation: Decision Making and Outcomes in Cancer Clinical Trials|
- Participation [ Designated as safety issue: No ]
- Decision satisfaction [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|