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Research Participation: Decision Making and Outcomes in Cancer Clinical Trials


N/A
18 Years
N/A
Open (Enrolling)
Both
Colorectal Cancer, Pancreatic Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

Research Participation: Decision Making and Outcomes in Cancer Clinical Trials


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Participation

Safety Issue:

No

Principal Investigator

Barbara Biedrzycki

Investigator Role:

Study Chair

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

JHOC-J0666, CDR0000530879

NCT ID:

NCT00478010

Start Date:

January 2007

Completion Date:

Related Keywords:

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

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410