NCT00352638

Brief Summary

RATIONALE: Printed educational materials and counseling by telephone may improve colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying standard or personalized printed educational materials with or without telephone counseling to compare how well they work in increasing colorectal cancer screening compliance in brothers and sisters of patients with colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
660

participants targeted

Target at P50-P75 for phase_3 colorectal-cancer

Timeline
Completed

Started Aug 2005

Typical duration for phase_3 colorectal-cancer

Geographic Reach
1 country

18 active sites

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

August 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 14, 2006

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

May 16, 2014

Status Verified

May 1, 2014

Enrollment Period

6.5 years

First QC Date

July 13, 2006

Last Update Submit

May 15, 2014

Conditions

Keywords

colon cancerrectal cancer

Outcome Measures

Primary Outcomes (1)

  • Colorectal cancer screening compliance

Secondary Outcomes (3)

  • Impact on movement in stage of adoption

  • Increased knowledge and attitudes

  • Cost

Interventions

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Sibling of a patient diagnosed with adenocarcinoma of the colon or rectum * Patient (proband) must meet the following criteria: * Diagnosed in 1999 or later * Currently living * Seen in Community Clinical Oncology Program member hospital * 60 and under at diagnosis * No history of hereditary cancer syndrome (e.g., familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer) (patient and sibling) * No history of colorectal cancer or colorectal polyps (sibling) * No history of inflammatory bowel disease (patient and sibling) PATIENT CHARACTERISTICS: * Age 40 and over OR within 10 years of proband's (patient's) age at diagnosis * English speaking PRIOR CONCURRENT THERAPY: * No prior colorectal cancer screening * May have undergone prior screening provided they have not followed, or do not plan to follow, physician's recommendation for screening

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

Sponsors & Collaborators

Study Sites (18)

Helen F. Graham Cancer Center at Christiana Care

Newark, Delaware, 19713, United States

Location

Lombardi Comprehensive Cancer Center at Georgetown University Medical Center

Washington D.C., District of Columbia, 20007, United States

Location

H. Lee Moffitt Cancer Center CCOP Research Base

Tampa, Florida, 33612, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Hunterdon Regional Cancer Center at Hunterdon Medical Center

Flemington, New Jersey, 08822, United States

Location

Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton

Marlton, New Jersey, 08053, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare

Vineland, New Jersey, 08360, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

PinnacleHealth Regional Cancer Center at Polyclinic Hospital

Harrisburg, Pennsylvania, 17105-8700, United States

Location

St. Mary Regional Cancer Center

Langhorne, Pennsylvania, 19047, United States

Location

Presbyterian Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Fox Chase Cancer Center CCOP Research Base

Philadelphia, Pennsylvania, 19140, United States

Location

Pottstown Memorial Regional Cancer Center

Pottstown, Pennsylvania, 19464, United States

Location

McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center

Reading, Pennsylvania, 19612-6052, United States

Location

Northeast Regional Cancer Institute

Scranton, Pennsylvania, 18510, United States

Location

M.D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

CounselingEarly Intervention, Educational

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesChild Health ServicesPreventive Health Services

Study Officials

  • Sharon Manne, PhD

    Fox Chase Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2006

First Posted

July 14, 2006

Study Start

August 1, 2005

Primary Completion

February 1, 2012

Study Completion

November 1, 2013

Last Updated

May 16, 2014

Record last verified: 2014-05

Locations