Breast CancerNCT01773980
CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
An observational study of Breast Cancer and Cervical Cancer, run by OHSU Knight Cancer Institute at 1 site in United States.
Trial summary
The goal of this project is to develop and pilot test an innovative approach for overcoming barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon. Read more about this study
- Who is it for?
- Ages 50 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- What is being tested?
- Clinic Intervention and Patient Intervention
- How many people
- 1,570 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinics
Who may be able to join
- Female
- Aged 50-75 at time of screening
- No personal history of breast, cervical or colorectal cancer
- Not being up-to-date with at least one screening test for breast, cervical, and/or colorectal cancer
- Meets the study definition of disability per screening survey OR
- Be a woman who does not meet the definition of disability per screening survey, but has been matched to a participant who does (observation group).
Who cannot join
- Non female
- Personal history of breast, cervical, or colorectal cancer
- Coming into clinic for an urgent care issue
Trial locations and contacts
1 site in 1 country.
United States1 site
OHSU Knight Cancer Institute
Portland, Oregon, 97239
About this study
Official title: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
The goal of this project is to develop and pilot test an innovative approach for overcoming barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon. Many studies have shown that people with disabilities receive fewer indicated cancer screening services and are more likely to have poor cancer-related outcomes, such as late stage at diagnosis, compared to those without disabilities.
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- Being tested
- Clinic Intervention, Patient Intervention
- Medical subject headings
- Breast Neoplasms, Uterine Cervical Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinic InterventionOther
The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff.
Patient InterventionOther
The patient intervention consists of a single 90-minute interactive in-person session.
| Study group | Role | What they receive |
|---|---|---|
| Patient and Clinic Intervention | The patient intervention consists of a single 90-minute interactive in-person session.
The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff. Receives: Other: Clinic Intervention; Other: Patient Intervention | |
| Patient Intervention Only | The patient intervention consists of a single 90-minute interactive in-person session. Receives: Other: Patient Intervention | |
| Clinic Intervention Only | The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff. Receives: Other: Clinic Intervention | |
| Neither Clinic nor Patient Intervention | Consists of no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with improved cancer screening
A 2 x 2 factorial study design will be used to explore individual and combined effects of a clinic-based intervention AND a patient-based intervention on improving breast, cervical and colorectal cancer screening among rural women with physical disabilities (WWD).
Measured: Duration of the study; Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by OHSU Knight Cancer InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 1,570 participants (actual)
Sponsor and investigators
- Lead sponsor
- OHSU Knight Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- David Buckley, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773980
- Sponsor's protocol ID
- IRB00009030
- Status last verified
- May 2015
- First submitted
- 18 Jan 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
- ClinicalTrials.gov ID
- NCT01773980
- Acronym / sponsor ID
- IRB00009030
- Conditions
- Breast Cancer, Cervical Cancer, Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,570 participants (actual)
- Lead sponsor
- OHSU Knight Cancer InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Aug 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this project is to develop and pilot test an innovative approach for overcoming barriers to cancer screening among women with physical disabilities (WWD) in rural Oregon. Many studies have shown that people with disabilities receive fewer indicated cancer screening services and are more likely to have poor cancer-related outcomes, such as late stage at diagnosis, compared to those without disabilities.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patient and Clinic Intervention | – | Other: Clinic Intervention, Other: Patient InterventionThe patient intervention consists of a single 90-minute interactive in-person session. The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff. |
| Patient Intervention Only | – | Other: Patient InterventionThe patient intervention consists of a single 90-minute interactive in-person session. |
| Clinic Intervention Only | – | Other: Clinic InterventionThe Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff. |
| Neither Clinic nor Patient Intervention | – | –Consists of no intervention |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinics
Key inclusion criteria (6 listed)
- Female
- Aged 50-75 at time of screening
- No personal history of breast, cervical or colorectal cancer
- Not being up-to-date with at least one screening test for breast, cervical, and/or colorectal cancer
- Meets the study definition of disability per screening survey OR
Key exclusion criteria (3 listed)
- Non female
- Personal history of breast, cervical, or colorectal cancer
- Coming into clinic for an urgent care issue
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 |
|---|---|---|
| Clinic InterventionThe Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff. | Other | Clinic Intervention Only, Patient and Clinic Intervention |
| Patient InterventionThe patient intervention consists of a single 90-minute interactive in-person session. | Other | Patient Intervention Only, Patient and Clinic Intervention |
Primary outcome
Number of participants with improved cancer screening
Time frame: Duration of the study; Up to 1 year
A 2 x 2 factorial study design will be used to explore individual and combined effects of a clinic-based intervention AND a patient-based intervention on improving breast, cervical and colorectal cancer screening among rural women with physical disabilities (WWD).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
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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.
David Buckley, MD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cervical Cancer, run by OHSU Knight Cancer Institute at 1 site 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 6 inclusion and 3 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 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with improved cancer screening (time frame: Duration of the study; Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 May 2015.