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Rural Interventions for Screening Effectiveness (RISE)

Primary Purpose

Breast, Cervical or Colorectal Cancer Screening Needed

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention via brochure
Educational Intervention via DVD
Educational Intervention-DVD & Telephone Based Navigation
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast, Cervical or Colorectal Cancer Screening Needed focused on measuring RISE

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center
  • Ohio State University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Arm I (TIDVD)

Arm II (TIDVD, PN)

Arm III (UC)

Arm Description

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 intervention participants receive brochures that explain and provide information and encouragement for cancer screening.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
June 6, 2016
Last Updated
September 27, 2023
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02795104
Brief Title
Rural Interventions for Screening Effectiveness
Acronym
RISE
Official Title
Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast, Cervical or Colorectal Cancer Screening Needed
Keywords
RISE

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
985 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (TIDVD)
Arm Type
Experimental
Arm Description
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.
Arm Title
Arm II (TIDVD, PN)
Arm Type
Experimental
Arm Description
Educational Intervention-DVD & Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator.
Arm Title
Arm III (UC)
Arm Type
Experimental
Arm Description
Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention via brochure
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention via DVD
Other Intervention Name(s)
Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Intervention Description
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Intervention Type
Behavioral
Intervention Name(s)
Educational Intervention-DVD & Telephone Based Navigation
Intervention Description
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
Primary Outcome Measure Information:
Title
Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms
Description
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
Secondary Outcome Measure Information:
Title
Cost Effectiveness of Each Intervention
Description
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
Title
Cost of the Interventions
Description
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.
Time Frame
Up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Electra Paskett, PhD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Victoria Champion, PhD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.
Citations:
PubMed Identifier
36328234
Citation
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.
Results Reference
derived
Links:
URL
http://cancer.osu.edu
Description
The James

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Rural Interventions for Screening Effectiveness

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