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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)

Overall Status

Completed

CT.gov ID

NCT00478010

Collaborator

National Cancer Institute (NCI) (NIH)

205

Enrollment

Location

20.3

Actual Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

205 participants

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

Actual Study Start Date :

Jan 19, 2007

Actual Primary Completion Date :

Sep 29, 2008

Actual Study Completion Date :

Sep 29, 2008

Outcome Measures

Primary Outcome Measures

Participation []
Decision satisfaction []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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