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

Primary Purpose

Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training
Cancer Screening intervention
Survey Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Training program

Arm Description

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.

Outcomes

Primary Outcome Measures

Develop the structural program
Development of the structural training program and accompanying tools
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).
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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2019
Last Updated
July 22, 2022
Sponsor
Fred Hutchinson Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04208724
Brief Title
Support Program for Adoption of Cancer Screening Interventions at a Rural Community-Based Organization
Official Title
Implementation Studio, an Innovative, Structured Approach to Facilitate Rural Community-Based Organizations' Adaptation and Implementation of Evidence-Based Interventions
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 18, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Carcinoma, Cervical Carcinoma, Colorectal Carcinoma, Malignant Solid Neoplasm

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Training program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training
Other Intervention Name(s)
Training Programs
Intervention Description
Participate in the training program
Intervention Type
Other
Intervention Name(s)
Cancer Screening intervention
Other Intervention Name(s)
cancer screening
Intervention Description
Receive cancer screening intervention
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Develop the structural program
Description
Development of the structural training program and accompanying tools
Time Frame
3 months
Title
Implementation Monitoring
Description
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).
Time Frame
4 months
Title
Intention to get screened for cancer (type of cancer will be determined by the community-based organization) pre- and post-intervention
Description
Difference in the proportion of intention to get screened for cancer pre- and post-intervention using chi-square analyses
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Linda Ko
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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