NCT00478010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2007

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2008

Completed
Last Updated

March 21, 2019

Status Verified

August 1, 2010

Enrollment Period

1.7 years

First QC Date

May 23, 2007

Last Update Submit

March 19, 2019

Conditions

Colorectal CancerPancreatic CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

psychosocial effects of cancer and its treatmentstage III colon cancerstage IV colon cancerstage III rectal cancerstage IV rectal cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancer

Outcome Measures

Primary Outcomes (2)

  • Participation

  • Decision satisfaction

Interventions

counseling interventionOTHER
study of socioeconomic and demographic variablesOTHER
psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsPancreatic NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CounselingPsychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesRehabilitationTherapeutics

Study Officials

  • Barbara Biedrzycki

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

January 19, 2007

Primary Completion

September 29, 2008

Study Completion

September 29, 2008

Last Updated

March 21, 2019

Record last verified: 2010-08

Locations

US(1)