NCT00632515

Brief Summary

The goal of this psychosocial research study is to learn about the knowledge, beliefs, and attitudes that people have toward screening for colorectal cancer. Another goal is to study how families communicate about colorectal cancer risk and colorectal cancer screening, with each other and with health care providers. Objectives:

  1. 1.To evaluate psychosocial and external factors influencing colorectal cancer (CRC) patients' communication with their first-degree relatives (FDRs) about CRC risk and screening information.
  2. 2.To evaluate psychosocial and external factors associated with CRC screening behavior among first-degree relatives of CRC patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 for all trials

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 29, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 3, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 10, 2008

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

12.4 years

First QC Date

March 3, 2008

Last Update Submit

June 12, 2020

Conditions

Keywords

Colorectal CancerCRCFamilial CRCCancer ScreeningQuestionnaireFirst Degree RelativesFDRsRisk Communication

Outcome Measures

Primary Outcomes (1)

  • Psychosocial + External factors influencing CRC patients' communication with FDRs about CRC risk & screening information

    2 Years

Study Arms (1)

Questionnaire

Patients with Colorectal Cancer and their First Degree Relatives (FDRs).

Behavioral: Questionnaire

Interventions

QuestionnaireBEHAVIORAL

Questionnaire regarding awareness of screening tests and attitudes toward colorectal cancer screening, taking 30-45 minutes to complete.

Also known as: Survey
Questionnaire

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with diagnosis of Colorectal Cancer at or before age 60 years, and their First Degree Relatives (FDRs) who are age 40 years or older.

You may qualify if:

  • Colorectal cancer (CRC) Patients: CRC patients will be eligible if they:
  • have a diagnosis of colorectal adenocarcinoma at or before age 60, and were diagnosed between 6 and 12 months prior to being contacted about this study (to allow adequate time for dissemination of CRC risk to family members, and to avoid interference with care surrounding the initial diagnosis);
  • have at least one living FDR age 40 years or older;
  • can read and speak English.
  • FDRs of CRC Patients: FDRs will be eligible if they
  • are age 40 years or older;
  • can read and speak English.

You may not qualify if:

  • CRC Patients: CRC patients will be excluded if they:
  • have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease); or
  • have an ECOG PS\>1.
  • FDRs of CRC patients: FDRs will be excluded if they:
  • have a history of a known hereditary CRC syndrome (e.g., HNPCC, familial polyposis) or inflammatory bowel disease (e.g., ulcerative colitis or Crohn's disease); or
  • have a personal history of colon polyps or of cancer diagnosed within 5 years prior to entry into the study, with the exception of nonmelanoma skin cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Susan Peterson, MPH,PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2008

First Posted

March 10, 2008

Study Start

January 29, 2008

Primary Completion

June 12, 2020

Study Completion

June 12, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Locations