Participatory Research to Advance Colon Cancer Prevention

Colorectal Cancer Clinical Trial

— PROMPT  

Official title:

Participatory Research to Advance Colon Cancer Prevention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03167125
• Other study ID #: 1U01MD010665-01
• Status: Completed
• Phase: N/A
• Start date: September 5, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: April 2022
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The overall goal of this study is to test strategies to raise rates of colorectal cancer screening among the Latino population in a federally qualified health center that operates multiple clinics. This intervention study will test automated and live prompts to a direct-mail fecal testing program in two phases.

In Phase I (Years 01 - 02), the investigators will tailor and define intervention components using a community-based participatory research approach called boot camp translation (BCT). The ultimate design of the intervention will be defined by patient and provider feedback from BCT. The investigators will then conduct a three-arm patient-randomized comparative effectiveness trial in two pilot clinics to compare 1) automated prompts (i.e., automated phone calls, text messages) to alert and remind patients to complete screening, 2) live prompts (i.e., live phone calls), and 3) a combination approach of automated plus live prompts.

In Phase II (Years 03 - 05), the investigators will spread and test the spread of the adapted intervention to additional clinics within the partnering health center using a two-arm main trial.

Both phases will be guided by an advisory group of clinicians, researchers, policy makers, and patients.

Description:

The study will fulfill the following aims:

Aim 1: Develop personalized messages (e.g., phone scripts, text messages, patient portal prompts) and define an intervention using boot camp translation to increase colon cancer screening among Latino populations.

Aim 2: Assess the reach, effectiveness, and differences by subgroup (e.g., preferred language) of a three-arm colorectal cancer screening program among Latino FQHC patients, in 2 clinics, through a patient randomized-controlled trial.

In addition to Usual Care, the arms are:

• Automated Prompts-an automated data-driven program for delivering FIT kit prompts (using automated phone calls, text messages, and/or emails) to patients due for colorectal cancer screening.

• Automated Plus Live Prompts-a higher-intensity program using automated, data-driven strategies for delivering FIT kit prompts plus linguistically and culturally tailored live prompts.

Aim 3: Test the spread of the program across additional clinics using a two-arm randomized approach and develop an implementation guide that includes outreach materials, strategies for incorporating patient input, and resources.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27580
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

Inclusion Criteria:

• Persons aged 50-75 years and not up-to-date with colorectal cancer screening

Exclusion Criteria:

• Persons having colorectal disease (e.g., ulcerative colitis or colectomy), personal history of colorectal cancer or colorectal disease, end-stage or life threatening diseases or, those known to be under hospice care or living in a skilled nursing facility may be excluded.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Automated Prompts
This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
• Automated Plus Live Prompts
This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.

Locations

Country	Name	City	State
United States	AltaMed Health Services	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Kaiser Permanente	AltaMed Health Services, Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increased colorectal cancer screening rates	Fecal testing completion	Up to 4 years (study period)