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

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: 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.

Official Title
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Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

Conditions
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Colorectal Cancer, Pancreatic Cancer, Psychosocial Effects of Cancer and Its Treatment

Intervention / Treatment
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* Other: counseling intervention
* Other: study of socioeconomic and demographic variables
* Procedure: psychosocial assessment and care
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Stage II-IV pancreatic cancer Stage III-IV colon cancer Stage III-IV rectal cancer Offered the opportunity to participate in a phase I-III cancer clinical trial and agreed or declined to participate First appointment at the Sidney Kimmel Comprehensive Cancer Center at John Hopkins PATIENT CHARACTERISTICS: Able to read English PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: counseling intervention|nan|
|Other: study of socioeconomic and demographic variables|nan|
|Procedure: psychosocial assessment and care|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participation |  |  | 
| Decision satisfaction |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial effects of cancer and its 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