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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03479645
• Other study ID #: 828624
• Status: Completed
• Phase: N/A
• Start date: March 23, 2018
• Est. completion date: June 16, 2018

Study information

• Verified date: July 2019
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: June 16, 2018
• Est. primary completion date: June 16, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Cancer
• Colon Cancer
• Colonic Neoplasms

Intervention

Behavioral:
• Serial text messages and mailed FIT kit
Pre-alert SMS offering Opt-out of mailed FIT kit Mailed home FIT kit SMS A - Reciprocity message SMS B - Offer for second FIT kit if lost/did not receive Plus SMS A + C if second mailed FIT is requested. SMS C - Salience message

Locations

Country	Name	City	State
United States	Family Practice and Councelling Network	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Colorectal screening rate	The rate patients with who completed colorectal screening within the trial period	12 weeks
Secondary	Per Protocol analysis: Colorectal screening rate	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
Secondary	FIT kit return rate	The rate of FIT kit return by trial arm	12 weeks
Secondary	Per protocol analysis: FIT kit return rate	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
Secondary	colonoscopy completion rate	The rate of colonoscopy within the trial period by trial arm	12 weeks
Secondary	Per protocol analysis: colonoscopy completion rate	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
Secondary	Colorectal screening return rate by gender	Uptake of screening and FIT return by gender	12 weeks
Secondary	FIT return rate by gender	Uptake of screening and FIT return by gender	12 weeks
Secondary	Colorectal screening rate by insurance status	Uptake of screening by insurance status	12 weeks
Secondary	FIT kit return rate by insurance status	FIT return by insurance status	12 weeks