Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT

July 18, 2019 updated by: University of Pennsylvania

Can a Multimodal Approach Using SMS Reminders and an Opt-out Mailed FIT Kits Improve Participation in Colorectal Cancer Screening? A Single Center Randomized Controlled Trial

This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary outcome is the rate of FIT kits being returned at 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It is estimated that colorectal cancer (CRC) screening can reduce the risk of dying from bowel cancer by approximately 15%. Yet despite this, the national participation rate is only approximately 62.9%, highlighting that the national target of 70.5% set out in the Healthy People 2020 Objectives remains well out of reach. The US Preventative Task Force (USPSTF) recommends colorectal screening for adults aged 50-75 years through either annual fecal occult blood testing (FOBT), flexible sigmoidoscopy every 5 years or colonoscopy every 10 years. However, many service providers rely on the opportunistic offer of screening at existing health touch-points. This requires the patient to see their healthcare provider, usually for a different clinical reason, the provider to recognize that the patient is overdue for CRC screening and the provider to recommend and book the patient for CRC screening. This process identifies a number of barriers encountered at the system, provider and patient level, to completing a screening test regularly. Furthermore, much evidence indicates that public participation in colorectal screening is heavily influences by socioeconomic factors. Lower participation rates are seen in individuals without health insurance, without a medical home, who are more deprived and from ethnic minority groups. These individuals are more likely to present with later stage disease and experience poorer outcomes. Fecal immunochemistry testing (FIT) is a stool sample based test kit that uses antibodies to detect the human haemoglobin protein in the stool sample and can be completed in the privacy of the home. Research has showed that mailed home test kits such as FOBT or FIT kits can improve CRC participation by reducing the effort required to see a provider in order to arrange CRC screening. Evidence has also shown that text message reminders can improve participation in cancer screening. Furthermore, the message content of text messages can differentially change behavior, for example reducing the 'did not attend rate' in hospital outpatient appointments but also in the context of participation in cervical cancer screening. Therefore this trial will test a multimodal outreach approach, which uses serial SMS reminders with different word contents and mailed FIT kits on the participation rates of CRC screening.

Study Type

Interventional

Enrollment (Actual)

440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19142
        • Family Practice and Councelling Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. aged 50-74
  2. at least 1 clinic visit to the FPCN within the previous 12 months
  3. due or overdue for colorectal screening
  4. Asymptomatic for bowel cancer
  5. mobile phone number available

Exclusion Criteria:

  1. 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)
  2. Has a history of CRC
  3. Has a history of other GI cancer
  4. Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis) Irritable bowel syndrome does not exclude patients.
  5. Has history of colitis other than Crohns disease or ulcerative colitis
  6. Has had a colectomy
  7. Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  8. Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  9. Has metastatic (Stage IV) blood or solid tumor cancer
  10. Has end stage renal disease
  11. Has dementia
  12. Has liver cirrhosis
  13. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic.
Experimental: Intervention
Serial text messages and mailed FIT kit
Behavioral: Serial text messages and mailed FIT kit
  1. Pre-alert SMS offering Opt-out of mailed FIT kit
  2. Mailed home FIT kit
  3. SMS A - Reciprocity message

  4. SMS B - Offer for second FIT kit if lost/did not receive

    • Plus SMS A + C if second mailed FIT is requested.
  5. SMS C - Salience message

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Colorectal screening rate
Time Frame: 12 weeks
The rate patients with who completed colorectal screening within the trial period
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per Protocol analysis: Colorectal screening rate
Time Frame: 12 weeks
The rate of FIT kit return by trial arm in individuals who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
12 weeks
FIT kit return rate
Time Frame: 12 weeks
The rate of FIT kit return by trial arm
12 weeks
Per protocol analysis: FIT kit return rate
Time Frame: 12 weeks
The rate of FIT kit return by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
12 weeks
colonoscopy completion rate
Time Frame: 12 weeks
The rate of colonoscopy within the trial period by trial arm
12 weeks
Per protocol analysis: colonoscopy completion rate
Time Frame: 12 weeks
The rate of colonoscopy within the trial period by trial arm, in participants who received at least the first text message, who did not self-report being up to date with colorectal cancer screening.
12 weeks
Colorectal screening return rate by gender
Time Frame: 12 weeks
Uptake of screening and FIT return by gender
12 weeks
FIT return rate by gender
Time Frame: 12 weeks
Uptake of screening and FIT return by gender
12 weeks
Colorectal screening rate by insurance status
Time Frame: 12 weeks
Uptake of screening by insurance status
12 weeks
FIT kit return rate by insurance status
Time Frame: 12 weeks
FIT return by insurance status
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Actual)

June 16, 2018

Study Completion (Actual)

June 16, 2018

Study Registration Dates

First Submitted

February 23, 2018

First Submitted That Met QC Criteria

March 26, 2018

First Posted (Actual)

March 27, 2018

Study Record Updates

Last Update Posted (Actual)

July 22, 2019

Last Update Submitted That Met QC Criteria

July 18, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 828624

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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