Trial Outcomes & Findings for Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia (NCT NCT05810714)

Results Overview

Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

94 participants

Primary outcome timeframe

At 2 months

Results posted on

2023-12-05

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (FIT, Usual Care) Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies	Arm II (FIT, Audio Brochure, Reminder) Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies	Arm III (FIT, Video Brochure, Reminder) Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies
Overall Study STARTED	20	42	32
Overall Study COMPLETED	20	42	32
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (FIT, Usual Care) n=20 Participants Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies	Arm II (FIT, Audio Brochure, Reminder) n=42 Participants Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies	Arm III (FIT, Video Brochure, Reminder) n=32 Participants Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies	Total n=94 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 4.4 • n=20 Participants	57.1 years STANDARD_DEVIATION 4.3 • n=42 Participants	57.1 years STANDARD_DEVIATION 4.2 • n=32 Participants	57.1 years STANDARD_DEVIATION 4.2 • n=94 Participants
Sex: Female, Male Female	10 Participants n=20 Participants	22 Participants n=42 Participants	15 Participants n=32 Participants	47 Participants n=94 Participants
Sex: Female, Male Male	10 Participants n=20 Participants	20 Participants n=42 Participants	17 Participants n=32 Participants	47 Participants n=94 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	20 participants n=20 Participants	42 participants n=42 Participants	32 participants n=32 Participants	94 participants n=94 Participants

PRIMARY outcome

Timeframe: At 2 months

Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study.

Outcome measures

Outcome measures
Measure	Arm I (FIT, Usual Care) n=20 Participants Participants receive the FIT kit and usual care on study. Best Practice: Receive usual care Fecal Immunochemical Test: Receive FIT kit Survey Administration: Ancillary studies	Arm II (FIT, Audio Brochure, Reminder) n=42 Participants Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive audio brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies	Arm III (FIT, Video Brochure, Reminder) n=32 Participants Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Fecal Immunochemical Test: Receive FIT kit Health Education: Receive video brochure Scheduled Notification: Receive scheduled reminder Survey Administration: Ancillary studies
Number of Participants to Return Fecal Immunochemical Test (FIT)	3 Participants	4 Participants	9 Participants

Adverse Events

Arm I (FIT, Usual Care)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (FIT, Audio Brochure, Reminder)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm III (FIT, Video Brochure, Reminder)

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

Dr. Mira Katz

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-6603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place