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

Colorectal Cancer Clinical Trial

Official title:

Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00478010
• Other study ID #: J0666
• Secondary ID: P30CA006973JHOC-
• Status: Completed
• Phase: N/A
• Start date: January 19, 2007
• Est. completion date: September 29, 2008

Study information

• Verified date: August 2010
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 205
• Est. completion date: September 29, 2008
• Est. primary completion date: September 29, 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Psychosocial Effects of Cancer and Its Treatment

Intervention

Other:
• counseling intervention

• study of socioeconomic and demographic variables

Procedure:
• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participation
Primary	Decision satisfaction