NCT00477646

Brief Summary

RATIONALE: Women may stay up-to-date with cancer screening if a health professional helps them overcome barriers to screening, including helping them to schedule cancer screening appointments. PURPOSE: This randomized clinical trial is studying the use of health professional-tailored telephone support compared with usual care from their personal doctor to help women overcome barriers to screening for colorectal, cervical, and breast cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,241

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2007

Typical duration for not_applicable breast-cancer

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

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 month until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 5, 2011

Status Verified

August 1, 2011

Enrollment Period

3.6 years

First QC Date

May 23, 2007

Last Update Submit

August 4, 2011

Conditions

Breast CancerCervical CancerColorectal Cancer

Keywords

colon cancerrectal cancerbreast cancercervical cancer

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients up-to-date (UTD) for colorectal cancer (CRC) screening

    Comparison of women in PCM and UC arms who received colon cancer screening tests during 18 month intervention period.

    18 months

Secondary Outcomes (2)

  • Percentage of patients UTD for breast and cervical cancer screening

    18 months

  • Comparison of UTD status for CRC screening with UTD status for cervical cancer and breast cancer screening

    18 months

Study Arms (2)

Prevention Care Management

EXPERIMENTAL

Telephone support over 18 months from trained Prevention Care Managers, to help women overcome barriers to colon, breast, and cervical cancer screening

Behavioral: Prevention Care Management

Usual Care

NO INTERVENTION

Usual Care. A sample of patients receive a single telephone call to validate claims data and collect basic demographic information.

Interventions

Prevention Care ManagementBEHAVIORAL

Telephone support over 18 months to help women become screened for breast, cervical and colon cancer. Includes barriers assessment, patient education and motivation, provider recommendation letter, appointment reminder, and some scheduling of appointments.

Prevention Care Management

Eligibility Criteria

Age50 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
DISEASE CHARACTERISTICS: * Enrolled in a participating Medicaid Managed Care Organization (MMCO) as a Medicaid patient for ≥ 12 months * Not up-to-date (UTD) for colorectal cancer screening * UTD status defined by any of the following: * Home fecal occult blood test within the past 12 months * Flexible sigmoidoscopy within the past 5 years * Double-contrast barium enema within the past 5 years * Colonoscopy within the past 10 years * Registered to receive primary care from a participating Community/Migrant Health Center, Diagnostic and Treatment Center, or other participating practice in New York City * Must have a telephone available * No MMCO claim for any of the following: * Colorectal, breast, or cervical cancer * Colon polyp removal * Total colectomy PATIENT CHARACTERISTICS: * Female * Able to use telephone * No plans to move for ≥ 1 year PRIOR CONCURRENT THERAPY: * See Disease Characteristics

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

Sponsors & Collaborators

Study Sites (1)

Clinical Directors Network, Incorporated

New York, New York, 10018, United States

Location

Related Publications (1)

  • Dietrich AJ, Tobin JN, Robinson CM, Cassells A, Greene MA, Dunn VH, Falkenstern KM, De Leon R, Beach ML. Telephone outreach to increase colon cancer screening in medicaid managed care organizations: a randomized controlled trial. Ann Fam Med. 2013 Jul-Aug;11(4):335-43. doi: 10.1370/afm.1469.

    PMID: 23835819DERIVED

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsColorectal NeoplasmsColonic NeoplasmsRectal Neoplasms

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

Study Officials

  • Allen J. Dietrich, MD

    Norris Cotton Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 23, 2007

First Posted

May 24, 2007

Study Start

July 1, 2007

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 5, 2011

Record last verified: 2011-08

Locations

US(1)