Breast, Cervical or Colorectal Cancer Screening NeededRISENCT02795104
Rural Interventions for Screening Effectiveness
A study testing Educational Intervention via brochure, Educational Intervention via DVD and Educational Intervention-DVD & Telephone Based Navigation in people with Breast, Cervical or Colorectal Cancer Screening Needed, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast, Cervical or Colorectal Cancer Screening Needed
- What is being tested?
- Educational Intervention via brochure, Educational Intervention via DVD and Educational Intervention-DVD & Telephone Based Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 985 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
Ohio State University Medical Center
Columbus, Ohio, 43210
About this study
Official title: Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Educational Intervention via brochure, Educational Intervention via DVD, Educational Intervention-DVD & Telephone Based Navigation
- Keywords
- RISE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention via brochureBehavioural
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Educational Intervention via brochure:
In this arm of the educational intervention the participant receives brochures
Educational Intervention via DVDBehavioural
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
Educational Intervention-DVD & Telephone Based NavigationBehavioural
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 group | Role | What they receive |
|---|---|---|
| Arm I (TIDVD) | Experimental | 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. Receives: Behavioral: Educational Intervention via DVD |
| Arm II (TIDVD, PN) | Experimental | Educational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. Receives: Behavioral: Educational Intervention-DVD & Telephone Based Navigation |
| Arm III (UC) | Experimental | Educational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. Receives: Behavioral: Educational Intervention via brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (2)
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.
Measured: Up to 12 months
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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2016 (estimated)
- Study startNov 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast, Cervical or Colorectal Cancer Screening NeededStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 985 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Electra Paskett, Ohio State University Comprehensive Cancer Center
- Investigators
- Electra Paskett, PhD, Principal investigator, Ohio State University Comprehensive Cancer CenterVictoria Champion, PhD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02795104
- Sponsor's protocol ID
- OSU-16108
- Other IDs
- NCI-2016-00774, R01CA196243
- Acronym
- RISE
- Status last verified
- Sep 2023
- First submitted
- 6 Jun 2016
- Last updated
- 2 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Champion VL, Paskett ED, Stump TE, Biederman EB, Vachon E, Katz ML, Rawl SM, Baltic RD, Kettler CD, Seiber EE, Xu WY, Monahan PO. Comparative Effectiveness of 2 Interventions to Increase Breast, Cervical, and Colorectal Cancer Screening Among Women in the Rural US: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2311004. doi: 10.1001/jamanetworkopen.2023.11004.
PubMed 37115541Biederman 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.
PubMed 36328234
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Interventions to Improve Screening Among Rural Women
- ClinicalTrials.gov ID
- NCT02795104
- Acronym / sponsor ID
- RISE / OSU-16108
- Keywords
- RISE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 985 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Nov 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 9 Jun 2016 (estimated)
- Results
- Posted 2 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (TIDVD) | Experimental | Behavioral: Educational Intervention via DVDEducational 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 II (TIDVD, PN) | Experimental | Behavioral: Educational Intervention-DVD & Telephone Based NavigationEducational Intervention-DVD \& Telephone based Navigation: In this arm of the intervention participants watch a TIDVD and are called by a patient navigator. |
| Arm III (UC) | Experimental | Behavioral: Educational Intervention via brochureEducational Intervention via brochure: In this arm of the intervention participants receive brochures that explain and provide information and encouragement for cancer screening. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention via brochureAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalEducational Intervention via brochure: In this arm of the educational intervention the participant receives brochures | Behavioural | Arm III (UC) |
| Educational Intervention via DVDAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalEducational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch | Behavioural | Arm I (TIDVD) |
| Educational Intervention-DVD & Telephone Based NavigationEducational 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 | Behavioural | Arm II (TIDVD, PN) |
Primary outcome
Percentage of Participants Who Received 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.
2 secondary outcomes
Cost Effectiveness of Each Intervention
Time frame: Up to 12 months
Cost of the Interventions
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37115541Champion VL, Paskett ED, Stump TE, Biederman EB, Vachon E, Katz ML, Rawl SM, Baltic RD, Kettler CD, Seiber EE, Xu WY, Monahan PO. Comparative Effectiveness of 2 Interventions to Increase Breast, Cervical, and Colorectal Cancer Screening Among Women in the Rural US: A Randomized Clinical Trial. JAMA Netw Open. 2023 Apr 3;6(4):e2311004. doi: 10.1001/jamanetworkopen.2023.11004.
- Derived from this study: PubMed 36328234Biederman 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.
- The JamesLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Electra Paskett, PhD principal investigator
Ohio State University Comprehensive Cancer Center
Victoria Champion, PhD principal investigator
Indiana University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention via brochure, Educational Intervention via DVD and Educational Intervention-DVD & Telephone Based Navigation in people with Breast, Cervical or Colorectal Cancer Screening Needed, run by Ohio State University Comprehensive Cancer Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Who Received All Needed Screening and Any Needed Screening Across the Three Randomized Arms (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02795104, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2023.