Breast, Cervical or Colorectal Cancer Screening Needed Clinical Trial
— RISEOfficial title:
Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
| Verified date | September 2023 |
| Source | Ohio State University Comprehensive Cancer Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 985 |
| Est. completion date | July 2020 |
| Est. primary completion date | July 2020 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 50 Years to 74 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Ohio State University Comprehensive Cancer Center | Columbus | Ohio |
| United States | Ohio State University Medical Center | Columbus | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Ohio State University Comprehensive Cancer Center | National Cancer Institute (NCI) |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Secondary | 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. | Up to 12 months | |
| Secondary | 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. | Up to 12 months |