NCT00376909

Brief Summary

RATIONALE: Studying the barriers that prevent minority and low-income women from undergoing cancer screening, and offering encouragement to them over the telephone, may help improve cancer screening rates. PURPOSE: This randomized phase II trial is studying how well a telephone-based Prevention Care Manager increases screening rates for breast cancer, cervical cancer, and colorectal cancer in minority and low-income women.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
2,729

participants targeted

Target at P75+ for phase_2 breast-cancer

Geographic Reach
1 country

2 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

November 1, 2001

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2006

Completed
Last Updated

December 2, 2014

Status Verified

September 1, 2006

Enrollment Period

2.4 years

First QC Date

September 13, 2006

Last Update Submit

November 26, 2014

Conditions

Breast CancerCervical CancerColorectal Cancer

Keywords

breast cancercervical cancercolon cancerrectal cancer

Outcome Measures

Primary Outcomes (2)

  • Follow-up patient cancer 3 months after completion of study treatment

  • Screening rates as measured by mammography, Pap test, hfoBT, sigmoidoscopy, barium enema and colonoscopy

Study Arms (2)

Intervention

EXPERIMENTAL

Series of telephone support calls from a trained prevention care manager

Other: educational interventionOther: study of socioeconomic and demographic variables

Usual Care

NO INTERVENTION

Usual care

Interventions

educational interventionOTHER
Intervention
study of socioeconomic and demographic variablesOTHER
Intervention

Eligibility Criteria

Age40 Years - 69 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Patients enrolled in the Prevention Care Manager (PCM) controlled, randomized clinical trial (RCT) must meet the following criteria: * Registered to receive care at a participating Community Health Center for at least 6 months * Overdue for at least one cancer screening as per the following time periods: * No mammography within the past 12 months * No Pap test within the past 12 months * No home fecal occult blood test within the past 12 months * No sigmoidoscopy within the past 5 years * No colonoscopy within the past 10 years * Must not plan to move out of area or change Community Health Center within 15 months * No unresolved, urgent abnormal cancer screening result found in medical record * Patients enrolled in the PCM dissemination pilot study through Affinity Health Plan must meet the following criteria: * Enrolled with Affinity Health Plan for at least 12 months * Overdue for at least one cancer screening as per the following time periods: * No mammography within the past 2 years * No Pap test within the past 3 years * No home fecal occult blood test within the past year for women ≥ 50 years old * No sigmoidoscopy within the past 5 years * No colonoscopy within the past 10 years * Must have received care at 1 of 6 participating Community Health Centers in New York City PATIENT CHARACTERISTICS: * Female * Must not be in acute distress or have an acute illness * Age 50 to 69 years for controlled study patients * Age 40 to 69 years for pilot study patients PRIOR CONCURRENT THERAPY: * No concurrent chemotherapy or radiotherapy * No concurrent active cancer treatment * No concurrent palliative care

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

Sponsors & Collaborators

Study Sites (2)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Clinical Directors Network, Incorporated

New York, New York, 10018, United States

Location

Related Publications (3)

  • Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Greene MA, Sox CH, Beach ML, DuHamel KN, Younge RG. Telephone care management to improve cancer screening among low-income women: a randomized, controlled trial. Ann Intern Med. 2006 Apr 18;144(8):563-71. doi: 10.7326/0003-4819-144-8-200604180-00006.

    PMID: 16618953RESULT

  • Dietrich AJ, Tobin JN, Cassells A, Robinson CM, Reh M, Romero KA, Flood AB, Beach ML. Translation of an efficacious cancer-screening intervention to women enrolled in a Medicaid managed care organization. Ann Fam Med. 2007 Jul-Aug;5(4):320-7. doi: 10.1370/afm.701.

    PMID: 17664498RESULT

  • Ogedegbe G, Cassells AN, Robinson CM, DuHamel K, Tobin JN, Sox CH, Dietrich AJ. Perceptions of barriers and facilitators of cancer early detection among low-income minority women in community health centers. J Natl Med Assoc. 2005 Feb;97(2):162-70.

    PMID: 15712779RESULT

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Allen J. Dietrich, MD

    Norris Cotton Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 15, 2006

Study Start

November 1, 2001

Primary Completion

April 1, 2004

Last Updated

December 2, 2014

Record last verified: 2006-09

Locations

US(2)