Making Decisions About Participating in a Cancer Clinical... | NCT00478010

Studies
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

NCT00478010

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Status

Completed

Last Update Posted

Mar 21, 2019Actual

Enrollment

205Actual

Phase

Not Applicable

Conditions

Colorectal Cancer
Pancreatic Cancer
Psychosocial Effects of Cancer and Its Treatment

Interventions

counseling intervention
study of socioeconomic and demographic variables
psychosocial assessment and care
quality-of-life assessment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
P30CA006973	U.S. NIH Grant/Contract		View source
JHOC-J0666
CDR0000530879
NA_00003458	Other Identifier	JHM IRB

Status Module

Record Verification Date

Aug 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2007Actual

Primary Completion Date

Sep 29, 2008Actual

Completion Date

Sep 29, 2008Actual

First Submitted Date

May 23, 2007

First Submission Date that Met QC Criteria

May 23, 2007

First Posted Date

May 24, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2019

Last Update Posted Date

Mar 21, 2019Actual

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

205Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
counseling intervention	Other
study of socioeconomic and demographic variables	Other
psychosocial assessment and care	Procedure
quality-of-life assessment	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participation
Decision satisfaction

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

120 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Barbara Biedrzycki	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins		Baltimore	Maryland	21231-2410	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms
D010190	Pancreatic Neoplasms
D003110	Colonic Neoplasms
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004066	Digestive System Diseases
D005767	Gastrointestinal Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases
D012002	Rectal Diseases
D004701	Endocrine Gland Neoplasms
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D003376	Counseling
D000067250	Psychiatric Rehabilitation

Ancestor Terms

ID	Term
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities
D003153	Community Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D012046	Rehabilitation
D013812	Therapeutics