Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Rural Interventions for Screening Effectiveness (RISE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795104
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : September 16, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date September 16, 2020
Actual Study Start Date  ICMJE October 2016
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Adherence to screening guidelines [ Time Frame: 12 months ]
    Will combine MRR and self-report by using MRR when available and self-report otherwise. Participants will be asked to provide contact information on both their primary care physician and any specialist who provided a screening test, reducing the chance of missing a test that was conducted but not reported to the primary care physician. For those who are lost to follow-up, a signed MRR form will enable the investigators to obtain the adherence outcome for those participants.
  • Binary adherence to all needed screening and any needed screening across the three randomized arms [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Adherence to screening guidelines [ Time Frame: 12 months ]
    Will combine MRR and self-report by using MRR when available and self-report otherwise. Participants will be asked to provide contact information on both their primary care physician and any specialist who provided a screening test, reducing the chance of missing a test that was conducted but not reported to the primary care physician. For those who are lost to follow-up, a signed MRR form will enable us to obtain the adherence outcome for those participants.
  • Binary adherence to all needed screening and any needed screening across the three randomized arms [ 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 w
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 9, 2016)
  • Cost effectiveness of each intervention assessed by QALY (Quality Adjusted Life Year)-based cost utility [ 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 (completed cancer screening tests). Analysis will emphasize the first two questions (cost of the intervention itself, calculation of net cost). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.
  • Cost of the interventions [ Time Frame: Up to 12 months ]
    In the model implemented in this study, the PN's spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the PN is full-time, data will be collected concerning at least the broad categories of time use, so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. The best way to do this will be a structured time log. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts will be used to provide the majority of this information. The procedures outlined above.
  • Cost savings [ Time Frame: Up to12 months ]
    In order to avoid distortions in the measured impact of an intervention due to pricing differences, all cancer screening tests will be assigned cost based on their Medicare allowable payment, regardless of how the service was actually paid for. While this is not a pure cost measure, it is comparable and avoids other potential distortions like differences in cost to charge ratio for different payers.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 6, 2016)
  • Cost effectiveness of each intervention assessed by QALY (Quality Adjusted Life Year)-based cost utility [ 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 (completed cancer screening tests). Analysis will emphasize the first two questions (cost of the intervention itself, calculation of net cost). CEA will consist of measuring the incremental cost of achieving the observed incremental outcomes, but not a cost-effectiveness ratio in standard terms.
  • Cost of the interventions [ Time Frame: Up to 12 months ]
    In the model implemented in this study, the PN's spend full time in that activity. Thus, the costs of implementation are straightforward and obtainable. Even though the PN is full-time, data will be collected concerning at least the broad categories of time use, so that the cost of specific components (e.g., arranging transportation) can be estimated more accurately. The best way to do this will be a structured time log. A developed Participant Encounter Form and a Tracking Log of Direct Participant Contacts will be used to provide the majority of this information. The procedures outlined abov
  • Cost savings [ Time Frame: Up to12 months ]
    In order to avoid distortions in the measured impact of an intervention due to pricing differences, all cancer screening tests will be assigned cost based on their Medicare allowable payment, regardless of how the service was actually paid for. While this is not a pure cost measure, it is comparable and avoids other potential distortions like differences in cost to charge ratio for different payers.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rural Interventions for Screening Effectiveness
Official Title  ICMJE Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Brief Summary 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

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Breast, Cervical or Colorectal Cancer Screening Needed
Intervention  ICMJE
  • Behavioral: Educational Intervention via brochure

    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
  • Behavioral: Educational Intervention via DVD
    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
  • Behavioral: 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
Study Arms  ICMJE
  • Experimental: ARM I (TIDVD)
    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.
    Intervention: Behavioral: Educational Intervention via DVD
  • Experimental: ARM II (TIDVD, PN)
    Educational Intervention-DVD & Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.
    Intervention: Behavioral: Educational Intervention-DVD & Telephone Based Navigation
  • Experimental: ARM III (UC)
    Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.
    Intervention: Behavioral: Educational Intervention via brochure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 6, 2016)
1058
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2022
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: The Ohio State University Comprehensive Cancer Center 877-304-2273 ext option 1 cathy.tatum@osumc.edu
Contact: Ryan Baltic 877-304-2273 ext option 2 ryan.baltic@osumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02795104
Other Study ID Numbers  ICMJE OSU-16108
NCI-2016-00774 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R01CA196243 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: 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.
Responsible Party Electra Paskett, Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Principal Investigator: Electra Paskett, PhD Ohio State University Comprehensive Cancer Center
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP