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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

Primary Purpose

Colorectal Cancer, Pancreatic Cancer, Psychosocial Effects of Cancer and Its Treatment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
study of socioeconomic and demographic variables
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colorectal Cancer focused on measuring 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

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Outcomes

Primary Outcome Measures

Participation
Decision satisfaction

Secondary Outcome Measures

Full Information

First Posted
May 23, 2007
Last Updated
March 19, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00478010
Brief Title
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
Official Title
Research Participation: Decision Making and Outcomes in Cancer Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
January 19, 2007 (Actual)
Primary Completion Date
September 29, 2008 (Actual)
Study Completion Date
September 29, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Pancreatic Cancer, Psychosocial Effects of Cancer and Its Treatment
Keywords
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Masking
None (Open Label)
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
counseling intervention
Intervention Type
Other
Intervention Name(s)
study of socioeconomic and demographic variables
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Participation
Title
Decision satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara Biedrzycki
Organizational Affiliation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Official's Role
Study Chair
Facility Information:
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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