NCT00792285

Brief Summary

This large randomized controlled trial is testing the effectiveness of automated telephone outreach with speech recognition to improve rates of screening for colorectal cancer. The hypothesis is that the intervention improves rates of screening overall and specifically rates of colonoscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80,000

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2005

Shorter than P25 for not_applicable colorectal-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

Study Start

First participant enrolled

March 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2008

Completed
Last Updated

November 17, 2008

Status Verified

November 1, 2008

Enrollment Period

1 year

First QC Date

November 13, 2008

Last Update Submit

November 13, 2008

Conditions

Colorectal Cancer

Keywords

Colon cancerPreventionScreeningTelephone

Outcome Measures

Primary Outcomes (1)

  • colorectal cancer screening

    one year

Secondary Outcomes (1)

  • colonoscopy screening

    one year

Study Arms (2)

Automated Telephone Outreach

EXPERIMENTAL

Automated Telephone Outreach with Speech Recognition

Behavioral: Automated Telephone Outreach with Speech Recognition

Usual Care

NO INTERVENTION

Usual Care

Interventions

Automated Telephone Outreach with Speech RecognitionBEHAVIORAL

Automated Telephone Outreach with Speech Recognition calls to health plan members to promote screening

Automated Telephone Outreach

Eligibility Criteria

Age50 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 50-64 at baseline
  • Continuous enrollment in health plan

You may not qualify if:

  • No telephone number on file
  • Enrolled in other telephone-based outreach program of the health plan
  • Share household with another eligible member
  • Evidence of colorectal cancer or polyps at baseline
  • Evidence of prior screening at baseline such that screening is not due at time of intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard Pilgrim Health Care

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Simon SR, Zhang F, Soumerai SB, Ensroth A, Bernstein L, Fletcher RH, Ross-Degnan D. Failure of automated telephone outreach with speech recognition to improve colorectal cancer screening: a randomized controlled trial. Arch Intern Med. 2010 Feb 8;170(3):264-70. doi: 10.1001/archinternmed.2009.522.

    PMID: 20142572DERIVED

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Steven R Simon, MD

    Harvard Pilgrim Health Care

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 13, 2008

First Posted

November 17, 2008

Study Start

March 1, 2005

Primary Completion

March 1, 2006

Study Completion

March 1, 2006

Last Updated

November 17, 2008

Record last verified: 2008-11

Locations

US(1)