Working...
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 : March 13, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Electra Paskett, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast, Cervical or Colorectal Cancer Screening Needed Behavioral: Educational Intervention via brochure Behavioral: Educational Intervention via DVD Behavioral: Educational Intervention-DVD & Telephone Based Navigation Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1058 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Study Start Date : October 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : September 2020

Arm Intervention/treatment
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.
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

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.
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

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.
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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795104


Contacts
Layout table for location contacts
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

Locations
Layout table for location information
United States, Ohio
Ohio State University Comprehensive Cancer Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Electra D. Paskett    614-293-3917    electra.paskett@osumc.edu   
Principal Investigator: Electra D. Paskett         
Ohio State University Medical Center Recruiting
Columbus, Ohio, United States, 43210
Contact: Electra D. Paskett    614-293-3917    electra.paskett@osumc.edu   
Principal Investigator: Electra D. Paskett         
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Electra Paskett, PhD Ohio State University Comprehensive Cancer Center

Additional Information:
Layout table for additonal information
Responsible Party: Electra Paskett, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02795104     History of Changes
Other Study ID Numbers: OSU-16108
NCI-2016-00774 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
R01CA196243 ( U.S. NIH Grant/Contract )
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Electra Paskett, Ohio State University Comprehensive Cancer Center:
RISE

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases