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

Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04208724
• Other study ID #: RG1006143
• Secondary ID: NCI-2019-0803310
• Status: Completed
• Phase: N/A
• Start date: November 18, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Carcinoma
• Breast Neoplasms
• Carcinoma
• Cervical Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Malignant Solid Neoplasm

Intervention

Other:
• Training
Participate in the training program
• Cancer Screening intervention
Receive cancer screening intervention
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Develop the structural program	Development of the structural training program and accompanying tools	3 months
Primary	Implementation Monitoring	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
Primary	Intention to get screened for cancer (type of cancer will be determined by the community-based organization) pre- and post-intervention	Difference in the proportion of intention to get screened for cancer pre- and post-intervention using chi-square analyses	Up to 3 months