Breast, Cervical or Colorectal Cancer Screening Needed
Conditions
Keywords
RISE
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.
Interventions
BEHAVIORALEducational Intervention via brochure
Educational Intervention via brochure: In this arm of the educational intervention the participant receives brochures
BEHAVIORALEducational Intervention via DVD
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
BEHAVIORALEducational 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
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 74 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost Effectiveness of Each Intervention | 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 (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 | Up to 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Educational Intervention via DVD: Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch | 382 |
| 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.
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 | 388 |
| 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.
Educational Intervention via brochure: Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures | 193 |
| Total | 963 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Determined to be Ineligible with Exit Data | 7 | 5 | 7 |
| Overall Study | Lost to Follow-up | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | ARM II (TIDVD, PN) | Total | ARM III (UC) | ARM I (TIDVD) |
|---|---|---|---|---|
| Age, Customized Age at consent | 58.8 years STANDARD_DEVIATION 6.3 | 58.6 years STANDARD_DEVIATION 6.3 | 58.8 years STANDARD_DEVIATION 6.3 | 58.2 years STANDARD_DEVIATION 6.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 5 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 3 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 12 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 375 Participants | 936 Participants | 185 Participants | 376 Participants |
| Region of Enrollment United States Indiana | 149 Participants | 378 Participants | 70 Participants | 159 Participants |
| Region of Enrollment United States Ohio | 239 Participants | 585 Participants | 123 Participants | 223 Participants |
| Sex/Gender, Customized Female | 388 Participants | 963 Participants | 193 Participants | 382 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 382 | 0 / 388 | 0 / 193 |
| other Total, other adverse events | 0 / 382 | 0 / 388 | 0 / 193 |
| serious Total, serious adverse events | 0 / 382 | 0 / 388 | 0 / 193 |
Outcome results
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.
Time frame: Up to 12 months
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Arm I (TIDVD) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received All Needed Screenings within 12-months of Enrollment | 57 Participants |
| Arm I (TIDVD) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received Any Needed Screening within 12-months of Enrollment | 110 Participants |
| Arm II (TIDVD, PN) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received All Needed Screenings within 12-months of Enrollment | 118 Participants |
| Arm II (TIDVD, PN) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received Any Needed Screening within 12-months of Enrollment | 189 Participants |
| Arm III (UC) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received All Needed Screenings within 12-months of Enrollment | 19 Participants |
| Arm III (UC) | Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms | Received Any Needed Screening within 12-months of Enrollment | 48 Participants |
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.
Time frame: Up to 12 months
Population: Same as main outcome. All participants included.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (TIDVD) | Cost Effectiveness of Each Intervention | 14,462.64 USD ('22) per completed UTD screening |
| Arm II (TIDVD, PN) | Cost Effectiveness of Each Intervention | 10,638.20 USD ('22) per completed UTD screening |
| Arm III (UC) | Cost Effectiveness of Each Intervention | 0 USD ('22) per completed UTD screening |
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.
Time frame: Up to 12 months
Population: Same as main outcome. All participants of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (TIDVD) | Cost of the Interventions | 326,012.29 US Dollars (2022) |
| Arm II (TIDVD, PN) | Cost of the Interventions | 670,841.46 US Dollars (2022) |
| Arm III (UC) | Cost of the Interventions | 0 US Dollars (2022) |