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Tailored Messaging for CRC Screening

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ClinicalTrials.gov Identifier: NCT03310892
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Behavioral: Generic message Behavioral: Tailored message Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Patient-directed Messaging to Increase Colorectal Cancer Screening
Actual Study Start Date : October 9, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
No Intervention: Usual Care
Participants in this arm will Usual scheduling process without any intervention
Experimental: Generic Message
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the study team member will ask the participant a series of 7 questions then receive a "generic" message encouraging colonoscopy scheduling.
Behavioral: Generic message
Generic message

Experimental: Tailored Message
Participants in this arm will receive a telephone call from a study team member, and if no answer, up to two additional attempts will be made. During the telephone call, the participant will answer a series of 7 questions then receive a "tailored" message encouraging colonoscopy scheduling, which will be determined by their responses to the preceding questions.
Behavioral: Tailored message
Tailored message




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
  2. 50-75 years of age
  3. 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:

  1. Age <50 or >75
  2. Pregnant woman
  3. 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
  4. History of colorectal cancer
  5. History of inflammatory bowel disease (Crohn's disease or Ulcerative colitis)
  6. History of colon surgery or resection
  7. History of symptoms concerning for colorectal cancer, such as lower GI bleeding, within the past 6 months
  8. Family history of a hereditary colorectal cancer syndrome, such as familial adenomatous polyposis (FAP) or hereditary non-polyposis colon cancer (HNPCC)
  9. 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.
  10. Dementia
  11. Does not speak English
  12. No telephone number listed in electronic medical record
  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): NCT03310892


Contacts
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Contact: Akinbowale O Oyalowo, MD 215-662-4301 Akinbowale.Oyalowo@uphs.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Health System Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jonathan A Epstein, MD    215-573-9306    evdcso@pennmedicine.upenn.edu   
Principal Investigator: Michael L Kochman, MD         
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Michael L Kochman, MD University of Pennsylvania
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03310892    
Other Study ID Numbers: 827866
First Posted: October 16, 2017    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
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:
Colorectal cancer screening
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases