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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 at Johns Hopkins.
Recruitment status was:  Active, not recruiting
First Posted : May 24, 2007
Last Update Posted : August 9, 2010
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

May 23, 2007
May 24, 2007
August 9, 2010
January 2007
December 2008   (Final data collection date for primary outcome measure)
  • Participation
  • Decision satisfaction
Same as current
Complete list of historical versions of study NCT00478010 on ClinicalTrials.gov Archive Site
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Not Provided
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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
Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

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.

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.

Interventional
Not Applicable
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • 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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
Same as current
Not Provided
December 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00478010
JHOC-J0666, CDR0000530879
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0666
JHOC-NA_00003458
Not Provided
Not Provided
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Study Chair: Barbara Biedrzycki Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP