NCT02795104|CompletedResultsDMC
Rural Interventions for Screening Effectiveness
RISE
Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
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Sponsor study identifier
Secondary identifiers
REGISTRY · CTRP (Clinical Trial Reporting Program)
NIH
interventional
985
1 country
2
Study Start
November 2016
Actual (reported)Primary Completion
July 2020
Actual (reported)Study Completion
July 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 6, 2016
Actual (reported)June 9, 2016
Actual (reported)November 2016
Actual (reported)July 2020
Actual (reported)July 2020
Actual (reported)October 2, 2023
Actual (reported)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
Cost Effectiveness of Each Intervention
Up to 12 months
Cost of the Interventions
Up to 12 months
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 educational intervention the participant receives brochures
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Champion VL, Paskett ED, Stump TE, Biederman EB, Vachon E, Katz ML, Rawl SM, Baltic RD, Kettler CD, Seiber EE, Xu WY, Monahan PO. Comparative Effectiveness of 2 Interventions to Increase Breast, Cervical, and Colorectal Cancer Screening Among Women in the Rural US: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2311004. doi: 10.1001/jamanetworkopen.2023.11004.
Biederman E, Baltic R, Katz ML, Rawl S, Vachon E, Monahan PO, Stump TE, Kettler C, Carter L, Young G, Xu W, Paskett ED, Champion V. Increasing breast, cervical, and colorectal cancer screening among rural women: Baseline characteristics of a randomized control trial. Contemp Clin Trials. 2022 Dec;123:106986. doi: 10.1016/j.cct.2022.106986. Epub 2022 Oct 31.
Electra Paskett, PhD
Ohio State University Comprehensive Cancer Center
Victoria Champion, PhD
Indiana University
985 participants (actual enrollment reported by the registry).
First Submitted
June 6, 2016
First Posted
June 9, 2016
Study Start
November 2016
Actual (reported)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 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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 2020
Actual (reported)Study Completion
July 2020
Actual (reported)Last Updated
October 2, 2023
Results First Posted
October 2, 2023
Record last verified: 2023-09
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.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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