NCT03479645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
440

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

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, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

March 23, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 16, 2018

Completed
Last Updated

July 22, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

February 23, 2018

Last Update Submit

July 18, 2019

Conditions

Bowel CancerColon Cancer

Keywords

Colon cancerBowel cancerCancer screeningtext messageFecal immunochemistry test (FIT)opt-outbehavioral intervention

Outcome Measures

Primary Outcomes (1)

  • Colorectal screening rate

    The rate patients with who completed colorectal screening within the trial period

    12 weeks

Secondary Outcomes (9)

  • Per Protocol analysis: Colorectal screening rate

    12 weeks

  • FIT kit return rate

    12 weeks

  • Per protocol analysis: FIT kit return rate

    12 weeks

  • colonoscopy completion rate

    12 weeks

  • Per protocol analysis: colonoscopy completion rate

    12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Control

NO INTERVENTION

Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic.

Intervention

EXPERIMENTAL

Serial text messages and mailed FIT kit

Behavioral: Serial text messages and mailed FIT kit

Interventions

Serial text messages and mailed FIT kitBEHAVIORAL

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

Intervention

Eligibility Criteria

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

You may qualify if:

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

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) Irritable bowel syndrome does not exclude patients.
  • Has history of colitis other than Crohns disease or ulcerative colitis
  • Has had a colectomy
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has dementia
  • Has liver cirrhosis
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Practice and Councelling Network

Philadelphia, Pennsylvania, 19142, United States

Location

Related Publications (7)

  • Hardcastle JD, Chamberlain JO, Robinson MH, Moss SM, Amar SS, Balfour TW, James PD, Mangham CM. Randomised controlled trial of faecal-occult-blood screening for colorectal cancer. Lancet. 1996 Nov 30;348(9040):1472-7. doi: 10.1016/S0140-6736(96)03386-7.

    PMID: 8942775BACKGROUND

  • Halpern MT, Ward EM, Pavluck AL, Schrag NM, Bian J, Chen AY. Association of insurance status and ethnicity with cancer stage at diagnosis for 12 cancer sites: a retrospective analysis. Lancet Oncol. 2008 Mar;9(3):222-31. doi: 10.1016/S1470-2045(08)70032-9. Epub 2008 Feb 20.

    PMID: 18282806BACKGROUND

  • Clegg LX, Li FP, Hankey BF, Chu K, Edwards BK. Cancer survival among US whites and minorities: a SEER (Surveillance, Epidemiology, and End Results) Program population-based study. Arch Intern Med. 2002 Sep 23;162(17):1985-93. doi: 10.1001/archinte.162.17.1985.

    PMID: 12230422BACKGROUND

  • Institute NC. Caner trends progress reprot; Colorectal Screening. https://progressreport.cancer.gov/detection/colorectal_cancer

    BACKGROUND

  • von Wagner C, Baio G, Raine R, Snowball J, Morris S, Atkin W, Obichere A, Handley G, Logan RF, Rainbow S, Smith S, Halloran S, Wardle J. Inequalities in participation in an organized national colorectal cancer screening programme: results from the first 2.6 million invitations in England. Int J Epidemiol. 2011 Jun;40(3):712-8. doi: 10.1093/ije/dyr008. Epub 2011 Feb 17.

    PMID: 21330344BACKGROUND

  • Power E, Miles A, von Wagner C, Robb K, Wardle J. Uptake of colorectal cancer screening: system, provider and individual factors and strategies to improve participation. Future Oncol. 2009 Nov;5(9):1371-88. doi: 10.2217/fon.09.134.

    PMID: 19903066BACKGROUND

  • Huf SW, Asch DA, Volpp KG, Reitz C, Mehta SJ. Text Messaging and Opt-out Mailed Outreach in Colorectal Cancer Screening: a Randomized Clinical Trial. J Gen Intern Med. 2021 Jul;36(7):1958-1964. doi: 10.1007/s11606-020-06415-8. Epub 2021 Jan 28.

    PMID: 33511567DERIVED

MeSH Terms

Conditions

Intestinal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesColorectal NeoplasmsColonic 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
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 27, 2018

Study Start

March 23, 2018

Primary Completion

June 16, 2018

Study Completion

June 16, 2018

Last Updated

July 22, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)