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CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01773980
Recruitment Status : Completed
First Posted : January 23, 2013
Last Update Posted : May 22, 2015
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Tracking Information
First Submitted Date January 18, 2013
First Posted Date January 23, 2013
Last Update Posted Date May 22, 2015
Study Start Date August 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 18, 2013)
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).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01773980 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CROSSROAD II: Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
Official Title Activating Rural Clinics and Women With Disabilities to Improve Cancer Screening
Brief 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. 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Primary care clinics
Condition
  • Breast Cancer
  • Cervical Cancer
  • Colorectal Cancer
Intervention
  • Other: Clinic Intervention
    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.
  • Other: Patient Intervention
    The patient intervention consists of a single 90-minute interactive in-person session.
Study Groups/Cohorts
  • 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.

    Interventions:
    • Other: Clinic Intervention
    • Other: Patient Intervention
  • Patient Intervention Only
    The patient intervention consists of a single 90-minute interactive in-person session.
    Intervention: 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.
    Intervention: Other: Clinic Intervention
  • Neither Clinic nor Patient Intervention
    Consists of no intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 20, 2015)
1570
Original Estimated Enrollment
 (submitted: January 18, 2013)
400
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Non female
  • Personal history of breast, cervical, or colorectal cancer
  • Coming into clinic for an urgent care issue
Sex/Gender
Sexes Eligible for Study: Female
Ages 50 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01773980
Other Study ID Numbers IRB00009030
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party OHSU Knight Cancer Institute
Study Sponsor OHSU Knight Cancer Institute
Collaborators National Institutes of Health (NIH)
Investigators
Principal Investigator: David Buckley, MD Oregon Health and Science University
PRS Account OHSU Knight Cancer Institute
Verification Date May 2015