NCT01210235

Brief Summary

The investigators overall goal is to develop, implement, test, and disseminate an intervention to increase colorectal cancer screening rates at Kaiser Permanente (KP) by providing home fecal immunochemical test kits (FIT) to eligible patients aged 50 and older who participate in annual influenza vaccination campaigns. The investigators hypothesis is that the FLU-FIT Program will be an effective method to increase colorectal cancer screening rates at Kaiser Permanente.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7,465

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable

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

October 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 25, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 28, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 6, 2015

Status Verified

March 1, 2015

Enrollment Period

2.2 years

First QC Date

September 25, 2010

Last Update Submit

March 5, 2015

Conditions

Colorectal Cancer Screening

Keywords

colorectal cancer screeningpreventive healthprimary care

Outcome Measures

Primary Outcomes (1)

  • Completion of colorectal cancer screening by eligible patients within 3 months of their flu shot

    We will determine the proportion of patients aged 50-75 who are eligible for colorectal cancer screening at the time of their annual flu shot and become up to date with colorectal cancer screening 3 months later.

    from time of getting flu shot until 3 months later

Study Arms (2)

FLU-FIT Arm

EXPERIMENTAL

In this arm, eligible patients aged 50-75 will be offered a FIT kit

Behavioral: FLU-FIT Program

FLU-Only Arm

NO INTERVENTION

In this arm, patients will receive flu shots as usual, without the FLU-FIT intervention.

Interventions

FLU-FIT ProgramBEHAVIORAL

In the intervention, eligible patients aged 50-75 who come in for flu shots and are due for colorectal cancer screening will be offered FIT.

FLU-FIT Arm

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 50-75 at the time of their flu shots who are also due for colorectal cancer screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente Northern California

Oakland, California, 94612, United States

Location

Study Officials

  • Michael Potter, MD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 25, 2010

First Posted

September 28, 2010

Study Start

October 1, 2009

Primary Completion

December 1, 2011

Study Completion

April 1, 2012

Last Updated

March 6, 2015

Record last verified: 2015-03

Locations

US(1)