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Gastrointestinal Neoplasms

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Rectal Diseases

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-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.

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:

In this arm of the educational intervention the participant receives brochures

Educational Intervention via brochure

Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch

Educational Intervention via DVD

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

Educational Intervention-DVD & Telephone Based Navigation

Electra Paskett, PhD

Victoria Champion, PhD

This randomized clinical trial studies how well a tailored interactive digital versatile disc (DVD) with or without patient navigation works in improving screening rates in rural women for breast cancer, cervical cancer or colorectal cancer. A tailored interactive DVD and patient navigation may help rural women to learn more about cancer screening and to better understand the results.

PRIMARY OBJECTIVES:

I. Compare the effectiveness of a tailored and interactive DVD (TIDVD) versus (vs.) TIDVD + telephone-based patient navigation (PN) intervention (TIDVD + PN) vs. usual care (UC), to increase guideline-based cancer screening rates at 12 months post randomization for breast cancer (BC), cervical cancer (CC), and colorectal cancer (CRC) among 1058 women age 50 to 74 living in rural northwest Ohio and northeast Indiana.

II. Compare the cost effectiveness of the TIDVD and the TIDVD + PN intervention vs. UC, for adherence to each screening outcome or combination of screening tests.

OUTLINE: Patients are randomized to 1 of 3 arms.

Arm I: Patients watch a tailored interactive DVD program and answer questions posed by the DVD program.

Arm II: Patients engage in TIDVD and PN.

Arm III: Patients receive brochures that explain and provide encouragement for cancer screening.

After completion of the study, patients are followed up at 2 and 12 months.

Rural Interventions for Screening Effectiveness

Comparative Effectiveness of Interventions to Improve Screening Among Rural Women

These data will only be used to characterize/compare the group individual to those who are eligible and agree to participate; with those who are ineligible and will not be shared after the completion of the study with other researchers.

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.

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.

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.

National Cancer Institute (NCI)

Ohio State University Comprehensive Cancer Center

Principal Investigator

TIDVD: In this arm of the intervention participants watch a tailored interactive DVD program and answer questions posed by the DVD program.

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

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

UC: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Arm III Usual Care (UC)

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 I (TIDVD)

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 II (TIDVD, PN)

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

ARM III (UC)

Total

Age at consent

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center
Rural Interventions for Screening Effectiveness	NCT02795104	Breast, Cervica...	Educational Int... Educational Int... Educational Int...	50 Years - 74 Years	Ohio State University Comprehensive Cancer Center

Spots Global Cancer Trial Database for breast, cervical or colorectal cancer screening needed