Trial Outcomes & Findings for Community Collaboration to Advance Racial/Ethnic Equity in CRC Screening (NCT NCT05714644)

Results Overview

completion rate of the stool-based screening test (FIT or Cologuard)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

5127 participants

Primary outcome timeframe

3 months

Results posted on

2025-12-26

Participant Flow

Recruitment Dates: 6/7/23 through 10/24/23

No enrolled patients were excluded from the study before assignment to arms.

Unit of analysis: community health center

Participant milestones

Participant milestones
Measure	Mailed FIT Kit A FIT kit mailed to the patient's home	Cologuard A Cologuard test mailed to the patient's home
Overall Study STARTED	2435 4	2692 4
Overall Study COMPLETED	2435 4	2692 4
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race/Ethnicity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mailed FIT Kit n=2435 Participants A FIT kit mailed to the patient's home	Cologuard n=2692 Participants A Cologuard test mailed to the patient's home	Total n=5127 Participants Total of all reporting groups
Age, Continuous	54.9 years STANDARD_DEVIATION 8.1 • n=30 Participants	54.2 years STANDARD_DEVIATION 8.1 • n=30 Participants	54.5 years STANDARD_DEVIATION 8.1 • n=60 Participants
Race/Ethnicity, Customized Non-Hispanic, White	456 Participants n=30 Participants • Race/Ethnicity	307 Participants n=30 Participants • Race/Ethnicity	763 Participants n=60 Participants • Race/Ethnicity
Race/Ethnicity, Customized Non-Hispanic, Black	196 Participants n=30 Participants • Race/Ethnicity	173 Participants n=30 Participants • Race/Ethnicity	369 Participants n=60 Participants • Race/Ethnicity
Race/Ethnicity, Customized Hispanic	1722 Participants n=30 Participants • Race/Ethnicity	2096 Participants n=30 Participants • Race/Ethnicity	3818 Participants n=60 Participants • Race/Ethnicity
Race/Ethnicity, Customized Other/Unknown	61 Participants n=30 Participants • Race/Ethnicity	116 Participants n=30 Participants • Race/Ethnicity	177 Participants n=60 Participants • Race/Ethnicity
Sex: Female, Male Female	1437 Participants n=30 Participants • Sex	1581 Participants n=30 Participants • Sex	3018 Participants n=60 Participants • Sex
Sex: Female, Male Male	998 Participants n=30 Participants • Sex	1111 Participants n=30 Participants • Sex	2109 Participants n=60 Participants • Sex

PRIMARY outcome

Timeframe: 3 months

completion rate of the stool-based screening test (FIT or Cologuard)

Outcome measures

Outcome measures
Measure	Mailed FIT Kit n=2435 Participants A FIT kit mailed to the patient's home	Cologuard n=2692 Participants A Cologuard test mailed to the patient's home
CRC Screening Completion Rates	550 Participants	751 Participants

SECONDARY outcome

Timeframe: 6 months

completion rate of the stool-based screening test (Cologuard or FIT)

Outcome measures

Outcome measures
Measure	Mailed FIT Kit n=2435 Participants A FIT kit mailed to the patient's home	Cologuard n=2692 Participants A Cologuard test mailed to the patient's home
CRC Screening Completion Rates	649 Participants	854 Participants

SECONDARY outcome

Timeframe: 6 months

Population: The number is for participants who returned an abnormal stool test within 180 days.

completion rate of diagnostic colonoscopy after an abnormal stool test result (overall and by arm)

Outcome measures

Outcome measures
Measure	Mailed FIT Kit n=42 Participants A FIT kit mailed to the patient's home	Cologuard n=58 Participants A Cologuard test mailed to the patient's home
Diagnostic Colonoscopy Completion Rates	13 Participants	23 Participants

Adverse Events

Mailed FIT Kit

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cologuard

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Haas, MD

Massachusetts General Hospital

Phone: 6176434266

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place