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OpenTrials
Completed

NCT Number: NCT03310892

Tailored Messaging for CRC Screening

This is a randomized controlled trial to to determine whether direct, tailored messaging to patients prior to scheduling colonoscopy will increase patient adherence to provider recommendation for screening colonoscopy.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

About this study

The proposed study is a prospective, randomized trial. All eligible subjects (patients identified to be contacted to schedule screening colonoscopy) will be randomized to one of three study arms: usual scheduling process (control), a generic message arm, or a tailored message arm. Patients in the "tailored message" arm will receive a telephone call and be asked a series of questions that will be used to assign patients to one of four messaging cohorts. After these questions have been answered, the patient will then receive a tailored message corresponding to his or her respective messaging cohort, encouraging them to schedule a colonoscopy with a directed script. In the "generic message" arm, patients will receive a telephone call and be asked to answer the same series of questions as the "tailored message" group, then receive a single, standard script encouraging them to schedule a colonoscopy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
  • 50-75 years of age
  • Due for CRC screening or surveillance (defined as no evidence of: colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, stool DNA test or Cologuard in the last 3 years)

Exclusion criteria

  • Age <50 or >75
  • Pregnant woman
  • Evidence of prior colonoscopy in the past 5 years, fecal immunochemical testing in the past 12 months, flexible sigmoidoscopy or CT colonography in the past 5 years, fecal DNA test or Cologuard in the last 3 years
  • History of colorectal cancer
  • History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
  • History of colon surgery or resection
  • History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months
  • Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)
  • Current serious medical condition with estimated life expectancy of less than 6 months, such as incurable cancer, end-stage congestive heart failure, decompensated cirrhosis, end stage renal disease, etc.
  • Dementia
  • Does not speak English
  • No telephone number listed in electronic medical record
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Treatment and study plan

Generic message

Behavioral

Generic message

Tailored message

Behavioral

Tailored message

Primary outcomes

  1. Colonoscopy completion rate

    Time frame: 120 days

    The ratio of the number of participants who complete a colonoscopy to the total number of enrolled participants

Secondary outcomes

  1. Colonoscopy scheduling rate

    Time frame: 120 days

    The ratio of the number of participants who schedule a colonoscopy to the total number of enrolled participants

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

Patient-directed Messaging to Increase Colorectal Cancer Screening

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Oct 16, 2017
Registry last updated
Oct 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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