Trial Outcomes & Findings for Rural Interventions for Screening Effectiveness (NCT NCT02795104)

Last Updated: 2023-10-02

Results Overview

Will be tested initially with pair-wise chi-square tests. Binary logistic regression analysis will be used to compare the two interventions and the UC group on the binary dependent variable (adherence), while adjusting for any potentially confounding covariates. The models will be controlled for any demographic covariate (e.g., age, education) for which the randomized groups differ significantly at baseline using a liberal significance level of 0.20 to achieve conservative adjustment. As a sensitivity analysis, multiple imputation will be used to impute the adherence outcome for participants.

Recruitment status

COMPLETED

Study phase

Target enrollment

985 participants

Primary outcome timeframe

Up to 12 months

Results posted on

2023-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.	Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	Arm III Usual Care (UC) UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.
Overall Study STARTED	389	395	201
Overall Study COMPLETED	382	388	193
Overall Study NOT COMPLETED	7	7	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD) TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.	Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN) TIDVD,PN: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	Arm III Usual Care (UC) UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.
Overall Study Determined to be Ineligible with Exit Data	7	5	7
Overall Study Withdrawal by Subject	0	2	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ARM I (TIDVD) n=382 Participants Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program. Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch	ARM II (TIDVD, PN) n=388 Participants Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. Educational Intervention-DVD \& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	ARM III (UC) n=193 Participants Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. Educational Intervention via brochure: Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures	Total n=963 Participants Total of all reporting groups
Age, Customized Age at consent	58.2 years STANDARD_DEVIATION 6.4 • n=5 Participants • Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.	58.8 years STANDARD_DEVIATION 6.3 • n=7 Participants • Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.	58.8 years STANDARD_DEVIATION 6.3 • n=5 Participants • Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.	58.6 years STANDARD_DEVIATION 6.3 • n=4 Participants • Nineteen participants (7 TIDVD, 5 TIDVD,PN, 7 UC) who enrolled and participated in the program were determined to be ineligible through additional cancer screening information obtained via exit medical record review. Two participants in the TIDVD,PN Arm withdrew and asked that their data not be used. Exit medical record data was unable to be obtained for one Usual Care participant. These 22 were excluded from analyses.
Sex/Gender, Customized Female	382 Participants n=5 Participants	388 Participants n=7 Participants	193 Participants n=5 Participants	963 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	5 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	376 Participants n=5 Participants	375 Participants n=7 Participants	185 Participants n=5 Participants	936 Participants n=4 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Region of Enrollment United States · Indiana	159 Participants n=5 Participants	149 Participants n=7 Participants	70 Participants n=5 Participants	378 Participants n=4 Participants
Region of Enrollment United States · Ohio	223 Participants n=5 Participants	239 Participants n=7 Participants	123 Participants n=5 Participants	585 Participants n=4 Participants

PRIMARY outcome

Timeframe: Up to 12 months

Outcome measures

Outcome measures
Measure	Arm I (TIDVD) n=382 Participants Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program. Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch	Arm II (TIDVD, PN) n=388 Participants Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. Educational Intervention-DVD \& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	Arm III (UC) n=193 Participants Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. Educational Intervention via brochure: Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures
Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms Received All Needed Screenings within 12-months of Enrollment	57 Participants	118 Participants	19 Participants
Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms Received Any Needed Screening within 12-months of Enrollment	110 Participants	189 Participants	48 Participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Same as main outcome. All participants included.

Cost-effectiveness analysis (CEA) implies a comparison of whether the cost per unit of outcome in one situation exceeds that in another. Unless the outcome measures are comparable, this is not possible. Will be able to examine outcomes of the interventions and the UC group (participants who up to date with all three cancer screening guidelines at 12 month follow-up). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.

Outcome measures

Outcome measures
Measure	Arm I (TIDVD) n=382 Participants Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program. Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch	Arm II (TIDVD, PN) n=388 Participants Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. Educational Intervention-DVD \& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	Arm III (UC) n=193 Participants Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. Educational Intervention via brochure: Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures
Cost Effectiveness of Each Intervention	14,462.64 USD ('22) per completed UTD screening	10,638.20 USD ('22) per completed UTD screening	0 USD ('22) per completed UTD screening

SECONDARY outcome

Timeframe: Up to 12 months

Population: Same as main outcome. All participants of study.

In the model implemented in this study, the patient navigators spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the navigator is full-time, data were collected concerning broad categories of time use through a structured time log so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts were used to provide the majority of this information.

Outcome measures

Outcome measures
Measure	Arm I (TIDVD) n=382 Participants Educational Intervention via DVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program. Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch	Arm II (TIDVD, PN) n=388 Participants Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. Educational Intervention-DVD \& Telephone Based Navigation: Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator	Arm III (UC) n=193 Participants Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. Educational Intervention via brochure: Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures
Cost of the Interventions	326,012.29 US Dollars (2022)	670,841.46 US Dollars (2022)	0 US Dollars (2022)

Adverse Events

Arm I Tailored and Interactive Digital Versatile Disc (DVD) (TIDVD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II TIDVD and Patient Navigation (PN) (TIDVD, PN)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm III Usual Care (UC)

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

Ryan Baltic

The Ohio State University Comprehensive Cancer Center

Phone: 614-293-4121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place