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

Research Participation: Decision Making and Outcomes in Cancer Clinical Trials

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Pancreatic Cancer; Psychosocial Effects of Cancer and Its Treatment
• Intervention / Treatment: Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment; Other: counseling intervention; Other: study of socioeconomic and demographic variables

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 Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21231-2410
      • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Participation
Decision satisfaction

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Barbara Biedrzycki, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2007
• Primary Completion (ACTUAL): September 29, 2008
• Study Completion (ACTUAL): September 29, 2008

Study Registration Dates

• First Submitted: May 23, 2007
• First Submitted That Met QC Criteria: May 23, 2007
• First Posted (ESTIMATE): May 24, 2007

Study Record Updates

• Last Update Posted (ACTUAL): March 21, 2019
• Last Update Submitted That Met QC Criteria: March 19, 2019
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: stage IV rectal cancer; stage IV colon cancer; stage III colon cancer; stage IV pancreatic cancer; psychosocial effects of cancer and its treatment; stage III rectal cancer; stage III pancreatic cancer; stage II pancreatic cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: J0666; P30CA006973 (U.S. NIH Grant/Contract); JHOC-J0666; CDR0000530879; NA_00003458 (OTHER: JHM IRB)