NCT04208724

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

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

December 10, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 23, 2019

Completed
11 months until next milestone

Study Start

First participant enrolled

November 18, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

1.6 years

First QC Date

December 10, 2019

Last Update Submit

July 22, 2022

Conditions

Outcome Measures

Primary Outcomes (3)

  • Develop the structural program

    Development of the structural training program and accompanying tools

    3 months

  • 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

  • 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

Study Arms (1)

Training program

EXPERIMENTAL

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.

Other: TrainingOther: Cancer Screening interventionOther: Survey Administration

Interventions

Participate in the training program

Also known as: Training Programs
Training program

Receive cancer screening intervention

Also known as: cancer screening
Training program

Ancillary studies

Training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

Related Publications (1)

  • Ko LK, Vu T, Bishop S, Leeman J, Escoffery C, Winer RL, Duran MC, Masud M, Rait Y. Implementation studio: implementation support program to build the capacity of rural community health educators serving immigrant communities to implement evidence-based cancer prevention and control interventions. Cancer Causes Control. 2023 Dec;34(Suppl 1):75-88. doi: 10.1007/s10552-023-01743-6. Epub 2023 Jul 13.

MeSH Terms

Conditions

Breast NeoplasmsUterine Cervical NeoplasmsColorectal Neoplasms

Interventions

Resistance TrainingMass Screening

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

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaDiagnostic Techniques and ProceduresDiagnosisHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDiagnostic ServicesPreventive Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Practice

Study Officials

  • Linda Ko

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2019

First Posted

December 23, 2019

Study Start

November 18, 2020

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 26, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations