NCT Number: NCT02795104
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.
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Notify Me50 year–74 year
Female
Interventional
Not applicable
Ohio State University Comprehensive Cancer Center, Columbus, Ohio, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
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
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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.
Time frame: Up to 12 months
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.
Ohio State University Comprehensive Cancer Center
Other
Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Acronym: RISE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
