Rural Interventions for Screening Effectiveness

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Effectiveness of Interventions to Improve Screening Among Rural Women

Conditions
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Breast, Cervical or Colorectal Cancer Screening Needed

Intervention / Treatment
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* Behavioral: Educational Intervention via brochure
* Behavioral: Educational Intervention via DVD
* Behavioral: Educational Intervention-DVD & Telephone Based Navigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be non-adherent to one or more recommended screenings for BC, CC, or CRC by Medical Record Review (MRR) Reside in one of 32 rural counties in Indiana (IN) or Ohio (OH) Provide informed consent Able to speak/read English Have access to a DVD player or computer that can play DVDs Exclusion Criteria: Have a personal or family history of any hereditary/genetic cancer syndrome such as BRCA1 and BRCA2 polymorphisms, hereditary nonpolyposis colon cancer, or familial adenomatous polyposis Have a personal history of inflammatory bowel disease (Crohn's disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer Have a first degree relative with a history of breast or colorectal cancer Plan to move outside of the country within the next year Reside in a nursing home or other institution Are pregnant or intend to become pregnant during the study period

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (TIDVD)<br>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. | Behavioral: Educational Intervention via DVD<br>* Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch<br>* Other names: Intervention, Educational;|
| Experimental: Arm II (TIDVD, PN)<br>Educational Intervention-DVD & Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. | Behavioral: Educational Intervention-DVD & Telephone Based Navigation<br>* 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<br>|
| Experimental: Arm III (UC)<br>Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. | Behavioral: Educational Intervention via brochure<br>* Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures<br>* Other names: Intervention, Educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | 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. | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost Effectiveness of Each Intervention | 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. | Up to 12 months | 
| Cost of the Interventions | 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. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RISE