NCT01773980

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,570

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 23, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

January 18, 2013

Last Update Submit

May 20, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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).

    Duration of the study; Up to 1 year

Study Arms (4)

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.

Other: Clinic InterventionOther: Patient Intervention

Patient Intervention Only

The patient intervention consists of a single 90-minute interactive in-person session.

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.

Other: Clinic Intervention

Neither Clinic nor Patient Intervention

Consists of no intervention

Interventions

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.

Clinic Intervention OnlyPatient and Clinic Intervention

The patient intervention consists of a single 90-minute interactive in-person session.

Patient Intervention OnlyPatient and Clinic Intervention

Eligibility Criteria

Age50 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinics

You may qualify if:

  • 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).

You may not qualify if:

  • Non female
  • Personal history of breast, cervical, or colorectal cancer
  • Coming into clinic for an urgent care issue

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsColorectal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David Buckley, MD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 23, 2013

Study Start

August 1, 2013

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations