NCT03310892

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 5, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 9, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 16, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

5.7 years

First QC Date

October 5, 2017

Last Update Submit

October 3, 2023

Conditions

Keywords

Colorectal cancer screening

Outcome Measures

Primary Outcomes (1)

  • Colonoscopy completion rate

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

    120 days

Secondary Outcomes (1)

  • Colonoscopy scheduling rate

    120 days

Study Arms (3)

Usual Care

NO INTERVENTION

Participants in this arm will Usual scheduling process without any intervention

Generic Message

EXPERIMENTAL

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

Tailored Message

EXPERIMENTAL

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

Interventions

Generic messageBEHAVIORAL

Generic message

Generic Message

Tailored message

Tailored Message

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • University of Pennsylvania Health System (UPHS) patients with an active order for screening or surveillance colonoscopy without an existing colonoscopy appointment
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

  • Oyalowo A, Forde KA, Lamanna A, Kochman ML. Effect of Patient-Directed Messaging on Colorectal Cancer Screening: A Randomized Clinical Trial. JAMA Netw Open. 2022 Mar 1;5(3):e224529. doi: 10.1001/jamanetworkopen.2022.4529.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Michael L Kochman, MD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 5, 2017

First Posted

October 16, 2017

Study Start

October 9, 2017

Primary Completion

June 30, 2023

Study Completion

October 1, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations