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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00478010

Enrollment

205

Registered

2007-05-24

Start date

2007-01-19

Completion date

2008-09-29

Last updated

2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHERcounseling intervention

OTHERstudy of socioeconomic and demographic variables

PROCEDUREpsychosocial assessment and care

PROCEDUREquality-of-life assessment

Study design

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 120 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Participation	—
Decision satisfaction	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026