NCT03072095

Brief Summary

This randomized controlled pilot study at the Health Annex, Family Practice \& Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
281

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 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

First Submitted

Initial submission to the registry

February 23, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 7, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2017

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

4 months

First QC Date

February 23, 2017

Last Update Submit

February 19, 2019

Conditions

Keywords

Colorectal NeoplasmsColonic NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesRectal Diseases

Outcome Measures

Primary Outcomes (1)

  • FIT completion within 3 months

    The percentage of participants who successfully complete the FIT

    3 months

Secondary Outcomes (1)

  • Response to text-based CRC screening outreach

    3 months

Study Arms (2)

Text-only

EXPERIMENTAL

Text-only outreach

Behavioral: Text-only

Text + Lottery

EXPERIMENTAL

Text outreach + financial incentive

Behavioral: Text + Lottery

Interventions

Text-onlyBEHAVIORAL

Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.

Text-only
Text + LotteryBEHAVIORAL

Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.

Text + Lottery

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 50 and 74 years old
  • Has active medical insurance
  • Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
  • Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
  • Asymptomatic for CRC

You may not qualify if:

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures)
  • Has a history of CRC
  • Has a history of other GI cancer
  • Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
  • Has a history of colon polyps
  • Has had a colectomy
  • Has a first-degree relative that has been diagnosed with CRC
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP).
  • Has iron deficiency anemia
  • Has recent history of lower GI bleeding
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has had congestive heart failure
  • Has dementia
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Practice & Counseling Network - Health Annex

Philadelphia, Pennsylvania, 19142, United States

Location

Related Publications (1)

  • Mehta SJ, Oyalowo A, Reitz C, Dean O, McAuliffe T, Asch DA, Doubeni CA. Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial. Prev Med Rep. 2020 May 8;19:101114. doi: 10.1016/j.pmedr.2020.101114. eCollection 2020 Sep.

MeSH Terms

Conditions

Colonic NeoplasmsColorectal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesRectal Diseases

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsNeoplasms by SiteIntestinal Diseases

Study Officials

  • Shivan Mehta, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 23, 2017

First Posted

March 7, 2017

Study Start

April 17, 2017

Primary Completion

August 3, 2017

Study Completion

November 3, 2017

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations