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Completed

NCT Number: NCT04208724

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

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Cervical Carcinoma Colonic Diseases Colorectal Carcinoma Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Intestinal Diseases Intestinal Neoplasms Malignant Solid Neoplasm Neoplasms Neoplasms by Site Rectal Diseases Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training

Other

Participate in the training program

Other names: Training Programs

Cancer Screening intervention

Other

Receive cancer screening intervention

Other names: cancer screening

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Develop the structural program

    Time frame: 3 months

    Development of the structural training program and accompanying tools

  2. 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).

  3. 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

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2019
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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