Providing Genetic And Environmental Cancer Risk Assessment In Primary Care
Collecte de données
Maladies du côlon+8
+ Maladies du système digestif
+ Néoplasmes du système digestif
Étude de screening
Résumé
Date de début de l'étude : 1 novembre 2003
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Part 1 * Determine the willingness of healthy participants to enroll in a genetic and environmental risk assessment for colorectal cancer. * Determine the impact of decision counseling on knowledge and attitudes about genetic and environmental risk assessment (GERA) and colorectal cancer screening in these participants. * Determine participants' understanding of GERA. * Determine participants' response to GERA results. Part 2 * Determine awareness of, and interest in, diet and genetic assessment for colorectal cancer among healthy participants at average risk for colorectal cancer who have not undergone regular colon cancer screening. * Determine participants' level of knowledge of this assessment. * Determine participants' rate of acceptance into this study. OUTLINE: This is a 2-part pilot study. * Part 1: Participants complete a baseline questionnaire on attitudes, beliefs, and knowledge about colorectal cancer (CRC), CRC screening, and diet and genetic testing for colorectal cancer risk. Two-four weeks later, participants are educated about CRC screening options and undergo genetic and environmental risk assessment (GERA) decision counseling about the methylene tetrahydrofolate reductase (MTHFR) gene and dietary folate intake. Participants who decide to undergo GERA undergo blood testing for MTHFR polymorphisms and folate levels. Participants whose blood tests indicate low folate levels are further counseled about dietary folate intake. * Part 2: Participants complete a questionnaire on attitudes, beliefs, and knowledge about CRC, CRC screening, and diet and genetic testing for colorectal cancer risk. Participants in part 1 are followed at 1 week, 1 month, and then at 6 months. PROJECTED ACCRUAL: A total of 110 participants (60 for part 1 and 50 for part 2) will be accrued for this study.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Screening
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 50 à 74 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
DISEASE CHARACTERISTICS: * Healthy participants * Eligible for colorectal cancer screening * No personal or family history of colorectal cancer * No more than 1 first-degree relative who has had colorectal cancer * Part 1: * Has not undergone regular screening for colorectal cancer * Part 2: * Not currently undergoing regular colon cancer testing, including any of the following: * Fecal occult blood testing within the past year * Flexible sigmoidoscopy or colonoscopy within the past 5 years PATIENT CHARACTERISTICS: Age * 50 to 74 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * No inflammatory bowel disease (part 1 only) * No concurrent health issues that would preclude study participation (part 1 only) * No history of cancer except basal cell or squamous cell skin cancer (part 2 only) * Able to speak and read English (part 2 only) PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 4 sites
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, United StatesVoir le siteKimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, United StatesFox Chase Cancer Center
Philadelphia, United StatesVanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville, United States