Overview

This trial is active, not recruiting.

Conditions colorectal cancer, pancreatic cancer, psychosocial effects of cancer and its treatment
Treatments counseling intervention, study of socioeconomic and demographic variables, psychosocial assessment and care, quality-of-life assessment
Sponsor Sidney Kimmel Comprehensive Cancer Center
Collaborator National Cancer Institute (NCI)
Start date January 2007
End date December 2008
Trial size 200 participants
Trial identifier NCT00478010, JHOC-J0666, JHOC-J0666, CDR0000530879, JHOC-NA_00003458, P30CA006973

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose health services research

Primary Outcomes

Measure
Participation
time frame:
Decision satisfaction
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Research Participation: Decision Making and Outcomes in Cancer Clinical Trials
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.