NCT03275987

Brief Summary

This study evaluates the effectiveness of persuasive direct mail materials coupled with an incentive for increasing breast and colorectal cancer screening among people enrolled in Medicaid. Half of age- and gender-appropriate enrollees received this intervention; the other half received the same intervention 15 months later

Trial Health

87
On Track

Trial Health Score

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

Enrollment
138,554

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Apr 2014

Typical duration 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

April 23, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2017

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

5 months

First QC Date

September 1, 2017

Last Update Submit

September 7, 2017

Conditions

Colorectal CancerBreast Cancer

Keywords

cancer screening

Outcome Measures

Primary Outcomes (1)

  • screening mammography or colonoscopy

    Evidence of a mammogram received after implementation of the intervention, based on presence of CPT codes in Medicaid claims data set.

    Within 12 weeks of first mailing

Study Arms (4)

Mammography treatment

EXPERIMENTAL

Mammography direct mail coupled with a financial incentive

Behavioral: Mammography direct mail coupled with a financial incentive

Mammography control/delayed intervention

ACTIVE COMPARATOR

Usual care (for 15 months); Mammography direct mail coupled with financial incentive (after 15 months)

Behavioral: Mammography direct mail coupled with a financial incentiveBehavioral: Usual care

Colonoscopy treatment

EXPERIMENTAL

Colonoscopy direct mail coupled with a financial incentive

Behavioral: Colonoscopy direct mail coupled with a financial incentive

Colonoscopy control/delayed intervention

ACTIVE COMPARATOR

Usual care (for 15 months); Colonoscopy direct mail coupled with financial incentive (after 15 months)

Behavioral: Usual careBehavioral: Colonoscopy direct mail coupled with a financial incentive

Interventions

Mammography direct mail coupled with a financial incentiveBEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Mammography control/delayed interventionMammography treatment
Usual careBEHAVIORAL

Group received usual care, and direct mail 15 months after treatment group received intervention.

Colonoscopy control/delayed interventionMammography control/delayed intervention
Colonoscopy direct mail coupled with a financial incentiveBEHAVIORAL

The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.

Colonoscopy control/delayed interventionColonoscopy treatment

Eligibility Criteria

Age50 Years - 74 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMammography arm was limited to women. Colonoscopy arm included both genders.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Enrolled in Minnesota Medicaid for at least the prior year

You may not qualify if:

  • Younger than 50 or older than 74
  • Women having mammogram in 15 months before trial (mammography intervention)
  • Evidence of a colonoscopy in the past 10 years, flexible sigmoidoscopy in the past five years, or fecal immunochemical or fecal occult blood test in the past year (colonoscopy intervention)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minnesota Department of Health

Saint Paul, Minnesota, 55164, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jonathan S Slater, PhD

    Minnesota Department of Health

    PRINCIPAL INVESTIGATOR

  • Christina L Nelson, MS

    Minnesota Department of Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Cancer Control Section

Study Record Dates

First Submitted

September 1, 2017

First Posted

September 8, 2017

Study Start

April 23, 2014

Primary Completion

September 30, 2014

Study Completion

May 10, 2017

Last Updated

September 11, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)