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 - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00478010

Purpose

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	Intervention
Cancer-Related Problem/Condition Colorectal Cancer Pancreatic Cancer	Other: counseling intervention Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: study of socioeconomic and demographic variables

MedlinePlus related topics: Cancer Colorectal Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research, Open Label
Official Title:	Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Participation [ Designated as safety issue: No ]
Decision satisfaction [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

National Cancer Institute (NCI)

Investigators

Study Chair:

Barbara Biedrzycki

Sidney Kimmel Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000530879, JHOC-J0666, JHOC-NA_00003458
Study First Received:	May 23, 2007
Last Updated:	March 7, 2009
ClinicalTrials.gov Identifier:	NCT00478010 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/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

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Rectal Neoplasm
Endocrine System Diseases
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Rectal Cancer
Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Endocrinopathy
Colorectal Neoplasms
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Pancreatic Neoplasms
Colonic Diseases
Endocrine System Diseases
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Pancreatic Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009