NCT02594150

Brief Summary

A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
897

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Dec 2015

Typical duration for not_applicable colorectal-cancer

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

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
29 days until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

2.2 years

First QC Date

October 29, 2015

Last Update Submit

February 19, 2019

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Increase in return rate of completed FIT

    An increase in return rate of completed FIT between intervention arms when compared to the control arm

    2 months

Study Arms (4)

usual care

NO INTERVENTION

Each FIT kit will include a tube in which to deposit the stool sample, directions on how to collect and mail the sample, a letter about colorectal cancer screening, a Labcorp requisition form, and a pre-paid return envelope.

unconditional fixed incentive

EXPERIMENTAL

This arm will receive a FIT kit as described in the mailed FIT arm and will also receive a financial incentive in the form of a gift card and a note explaining that this gift card is a token of our appreciation for completing the kit.

Other: Financial Incentive

conditional fixed incentive

EXPERIMENTAL

This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.

Other: Financial Incentive

conditional lottery incentive

EXPERIMENTAL

This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will be entered in a 1/10 chance lottery to receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.

Other: Financial Incentive

Interventions

Financial IncentiveOTHER

Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.

conditional fixed incentiveconditional lottery incentiveunconditional fixed incentive

Eligibility Criteria

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

You may qualify if:

  • Between 50 to 75 years old
  • Has had at least two visits at Penn Family Care Within the past two years - Due for screening
  • Asymptomatic for colorectal cancer (CRC)
  • Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
  • Have a primary care provider in Penn Family Care

You may not qualify if:

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (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. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
  • Has history of colitis other than Crohn's disease or ulcerative colitis
  • Has had a colectomy
  • Has a 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 anemia (iron-deficient or general/unspecified)
  • Has 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Mehta SJ, Pepe RS, Gabler NB, Kanneganti M, Reitz C, Saia C, Teel J, Asch DA, Volpp KG, Doubeni CA. Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191156. doi: 10.1001/jamanetworkopen.2019.1156.

    PMID: 30901053DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shivan Mehta, MD MBA MSHP

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Chyke Doubeni, MD MPH

    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
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2018

Study Completion

September 1, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02