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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

Brief Summary:

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 Phase
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 Applicable

Detailed Description:

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.


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

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Participation
  2. Decision satisfaction


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Cancer Institute (NCI)
Investigators
Study Chair: Barbara Biedrzycki Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

ClinicalTrials.gov Identifier: NCT00478010     History of Changes
Other Study ID Numbers: JHOC-J0666, CDR0000530879
P30CA006973 ( U.S. NIH Grant/Contract )
JHOC-J0666
JHOC-NA_00003458
First Posted: May 24, 2007    Key Record Dates
Last Update Posted: August 9, 2010
Last Verified: August 2010

Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
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

Additional relevant MeSH terms:
Colorectal Neoplasms
Pancreatic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases