RightFit
Not yet recruitingNot applicable

Smartphone-enabled Hybrid Identification of Early CoLorectal Disease Using Blood-Based Cancer Testing Across TeXas

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years to 84 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether adults ages 45–84 at average risk for colon or rectal cancer accept and complete blood-based cancer screening, including a repeat test after 1 year if the first result is negative. It also tests whether app-based support helps people with a positive blood test get a colonoscopy, an exam inside the colon. Patients are placed by chance into a group with or without app-based support.

The goal of this prospective implementation study is to understand the impact of a blood-based screening test (BBST) for colorectal cancer (CRC) on patient acceptability of and adherence to CRC screening as well as the rate of follow-up BBST in those with negative BBST at a 1-year interval. Additional aims include assessing the impact of digital patient navigation intervention on the rate of follow-up colonoscopy in individuals with positive BBST. Patients will be randomized into the non-intervention arm or the intervention with an app arm.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 45–84 years old.
  • Your health care provider considers you at average risk for colon or rectal cancer under screening guidelines.
  • If you choose blood-based screening, you are able and willing to give the required blood samples.
  • You can understand the study and are willing to take part.
  • You were seen at an HTPN clinic within the 24 months before the study started.
  • You have an active MyBSW app portal account or will create one during recruitment.

Who can't join

  • You have had colon or rectal cancer.
  • Your family history puts you at high risk for colon or rectal cancer.
  • You have inflammatory bowel disease, which causes swelling in the bowel, or have had polyps, which are growths in the colon or rectum.
  • You currently have symptoms of colon or rectal cancer, such as blood in your stool.
  • The study doctor believes a known health condition makes you unable to join.
  • Your electronic health record shows up-to-date screening: a FIT stool blood test within 1 year, a stool DNA test within 3 years, or a colonoscopy within 10 years.
  • You had an abnormal colonoscopy result before and are due for a follow-up exam.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * patients aged 45-84 years of age * Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines * If a patient opts for BBST, they are able and willing to provide blood samples per protocol * Ability to understand and the willingness to participate in the study * Must have been seen in HTPN clinic within the past 24 months from study activation * Must have active MyBSW app portal account and/or establish account during study recruitment Exclusion Criteria: * Patients with a personal history of CRC * Patients with a known high-risk family history of CRC precluding the patient from being average risk * Patients with known diagnosis of inflammatory bowel disease or history of polyps * Patients who are currently symptomatic for CRC such as: blood in the stool * Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study * Have a recorded up to date CRC screening in the EMR (within 1 year for FIT, 3 years for mt-sDNA, 10 years for colonoscopy) * Patients with a previous abnormal colonoscopy finding who are due for surveillance.

Study sites (1)

TX