Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization

July 22, 2022 updated by: Fred Hutchinson Cancer Center

Implementation Studio, an Innovative, Structured Approach to Facilitate Rural Community-Based Organizations' Adaptation and Implementation of Evidence-Based Interventions

This pilot trial study uses a structural support program for adoption of cancer screening interventions at a rural community-based organization. Rural communities face unique barriers in implementation of evidence-based interventions due to a lack of infrastructure, community capacity, and expertise as academic and research centers are often clustered in urban areas. The support program may help a rural community-based organization select, adapt, and implement cancer prevention and control evidence-based interventions.

Study Overview

Detailed Description

OUTLINE:

Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members.

After completion of study, participants are followed up at 3 months.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Objective II COMMUNITY-BASED ORGANIZATION: Located in the Yakima Valley of Washington State
  • Objective II COMMUNITY-BASED ORGANIZATION: Serve community members who are 18 and older
  • Objective II COMMUNITY-BASED ORGANIZATION: Willing to commit to the 6-month program
  • Objective II PARTICIPANTS: Receiving services from the recruited community-based organization
  • Objective III PARTICIPANTS: Not up-to-date for breast, cervical, and colorectal cancer screening according to current U.S. Preventive Services Tasks Force (USPSTF) guidelines. The current USPSTF recommendations for breast, cervical, and colorectal cancer are:

    • Breast Cancer Screening: Women ages 50-74 should be screened for breast cancer with mammography every 2 years.
    • Cervical Cancer Screening: Women ages 21-29 should be screened for cervical cancer every 3 years with cervical cancer cytology alone. For women ages 30-65, the USPSTF recommends screening every 3 years with cervical cytology alone, every 5 years or every 5 years with high risk human papillomavirus (hrHPV) testing in combination of cytology.
    • Colorectal Cancer Screening: Individuals ages 50-75 should be screened for colorectal cancer with guaiac-based fecal occult blood tests (gFOBT) or fecal immunochemical test (FIT) once a year, or colonoscopy every 10 years (USPSTF approves additional screening tests, but these are the most commonly used).
  • Objective III PARTICIPANTS: If the community-based organization selects breast cancer screening, we will recruit women ages 50-74.
  • Objective III PARTICIPANTS: If the community-based organization selects cervical cancer screening, we will recruit women ages 21-65.
  • Objective III PARTICIPANTS: If the community-based organization selects colorectal cancer screening, we will recruit women and men ages 50-75.
  • Objective III PARTICIPANTS: Average risk for breast, cervical, or colorectal cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Training program
Community-based organizations participate in the support program, consisting of 2 half-day training workshops over 2 weeks, and 30-minute bi-weekly consultations in order to adapt and implement the cancer screening intervention for community members.
Ancillary studies
Participate in the training program
Other Names:
  • Training Programs
Receive cancer screening intervention
Other Names:
  • cancer screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Develop the structural program
Time Frame: 3 months
Development of the structural training program and accompanying tools
3 months
Implementation Monitoring
Time Frame: 4 months
Implementation of the evidence-based intervention by the community-based organization including 1) dosage (how many interventions were delivered to the participants), 2) types (for which cancer), 3) length of exposure (for how long), and 4) who is involved in the implementation (by whom).
4 months
Intention to get screened for cancer (type of cancer will be determined by the community-based organization) pre- and post-intervention
Time Frame: Up to 3 months
Difference in the proportion of intention to get screened for cancer pre- and post-intervention using chi-square analyses
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2020

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

December 10, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 23, 2019

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 22, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Malignant Solid Neoplasm

Clinical Trials on Survey Administration

Subscribe