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

Johns Hopkins Medicine

Status: Completed

Conditions: Psychosocial Effects of Cancer and Its Treatment; Pancreatic Cancer; Colorectal Cancer

Treatments: Other: counseling intervention; Procedure: quality-of-life assessment; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00478010

CDR0000530879

P30CA006973 (U.S. NIH Grant/Contract)

J0666

JHOC-J0666

NA_00003458 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 205 patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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