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

March 19, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J0666
  • P30CA006973 (U.S. NIH Grant/Contract)
  • JHOC-J0666
  • CDR0000530879
  • NA_00003458 (OTHER: JHM IRB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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