Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT
Primary Purpose
Bowel Cancer, Colon Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Serial text messages and mailed FIT kit
Sponsored by
About this trial
This is an interventional screening trial for Bowel Cancer focused on measuring Colon cancer, Bowel cancer, Cancer screening, text message, Fecal immunochemistry test (FIT), opt-out, behavioral intervention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Family Practice and Councelling Network
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Intervention
Arm Description
Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic.
Serial text messages and mailed FIT kit
Outcomes
Primary Outcome Measures
Colorectal screening rate
The rate patients with who completed colorectal screening within the trial period
Secondary Outcome Measures
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.
FIT kit return rate
The rate of FIT kit return by trial arm
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.
colonoscopy completion rate
The rate of colonoscopy within the trial period by trial arm
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.
Colorectal screening return rate by gender
Uptake of screening and FIT return by gender
FIT return rate by gender
Uptake of screening and FIT return by gender
Colorectal screening rate by insurance status
Uptake of screening by insurance status
FIT kit return rate by insurance status
FIT return by insurance status
Full Information
NCT ID
NCT03479645
First Posted
February 23, 2018
Last Updated
July 18, 2019
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT03479645
Brief Title
Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
March 23, 2018 (Actual)
Primary Completion Date
June 16, 2018 (Actual)
Study Completion Date
June 16, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bowel Cancer, Colon Cancer
Keywords
Colon cancer, Bowel cancer, Cancer screening, text message, Fecal immunochemistry test (FIT), opt-out, behavioral intervention
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
440 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic.
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Serial text messages and mailed FIT kit
Intervention Type
Behavioral
Intervention Name(s)
Serial text messages and mailed FIT kit
Intervention Description
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
Primary Outcome Measure Information:
Title
Colorectal screening rate
Description
The rate patients with who completed colorectal screening within the trial period
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Per Protocol analysis: Colorectal screening rate
Description
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.
Time Frame
12 weeks
Title
FIT kit return rate
Description
The rate of FIT kit return by trial arm
Time Frame
12 weeks
Title
Per protocol analysis: FIT kit return rate
Description
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.
Time Frame
12 weeks
Title
colonoscopy completion rate
Description
The rate of colonoscopy within the trial period by trial arm
Time Frame
12 weeks
Title
Per protocol analysis: colonoscopy completion rate
Description
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.
Time Frame
12 weeks
Title
Colorectal screening return rate by gender
Description
Uptake of screening and FIT return by gender
Time Frame
12 weeks
Title
FIT return rate by gender
Description
Uptake of screening and FIT return by gender
Time Frame
12 weeks
Title
Colorectal screening rate by insurance status
Description
Uptake of screening by insurance status
Time Frame
12 weeks
Title
FIT kit return rate by insurance status
Description
FIT return by insurance status
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Practice and Councelling Network
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19142
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
8942775
Citation
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Results Reference
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Results Reference
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PubMed Identifier
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Citation
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Results Reference
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Citation
Institute NC. Caner trends progress reprot; Colorectal Screening. https://progressreport.cancer.gov/detection/colorectal_cancer
Results Reference
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21330344
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
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PubMed Identifier
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Citation
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.
Results Reference
derived
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Serial SMS Reminders and an Opt-out Mailed FIT Kits to Improve Colorectal Screening Participation: A Single Center RCT
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