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Trial record 100 of 663 for:    SMS

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

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ClinicalTrials.gov Identifier: NCT03479645
Recruitment Status : Completed
First Posted : March 27, 2018
Last Update Posted : July 22, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Bowel Cancer Colon Cancer Behavioral: Serial text messages and mailed FIT kit Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Screening
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
Actual Study Start Date : March 23, 2018
Actual Primary Completion Date : June 16, 2018
Actual Study Completion Date : June 16, 2018

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




Primary Outcome Measures :
  1. Colorectal screening rate [ Time Frame: 12 weeks ]
    The rate patients with who completed colorectal screening within the trial period


Secondary Outcome Measures :
  1. 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.

  2. FIT kit return rate [ Time Frame: 12 weeks ]
    The rate of FIT kit return by trial arm

  3. 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.

  4. colonoscopy completion rate [ Time Frame: 12 weeks ]
    The rate of colonoscopy within the trial period by trial arm

  5. 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.

  6. Colorectal screening return rate by gender [ Time Frame: 12 weeks ]
    Uptake of screening and FIT return by gender

  7. FIT return rate by gender [ Time Frame: 12 weeks ]
    Uptake of screening and FIT return by gender

  8. Colorectal screening rate by insurance status [ Time Frame: 12 weeks ]
    Uptake of screening by insurance status

  9. FIT kit return rate by insurance status [ Time Frame: 12 weeks ]
    FIT return by insurance status



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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03479645


Locations
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United States, Pennsylvania
Family Practice and Councelling Network
Philadelphia, Pennsylvania, United States, 19142
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Shivan Mehta, MD University of Pennsylvania

Publications:
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03479645     History of Changes
Other Study ID Numbers: 828624
First Posted: March 27, 2018    Key Record Dates
Last Update Posted: July 22, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Pennsylvania:
Colon cancer
Bowel cancer
Cancer screening
text message
Fecal immunochemistry test (FIT)
opt-out
behavioral intervention
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases