NCT05313737

Brief Summary

This is a randomized controlled trial that will evaluate the effectiveness two different outreach strategies for a population-based breast cancer screening program at the VA Puget Sound among average risk female Veterans who are due for breast cancer screening.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
871

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
12 days until next milestone

Study Start

First participant enrolled

April 18, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

5 months

First QC Date

February 1, 2022

Last Update Submit

April 5, 2022

Conditions

Breast Cancer

Keywords

Cancer ScreeningAdherence

Outcome Measures

Primary Outcomes (1)

  • Percentage of mammograms completed at 100 days post randomization

    Percent of mammograms completed

    100 days post randomization

Secondary Outcomes (1)

  • Percentage of mammograms scheduled at 100 days post randomization

    100 days post randomization

Other Outcomes (2)

  • Percentage of mammograms cancelled at 100 days post randomization

    100 days post randomization

  • Percentage of mammograms active at 100 days post randomization

    100 days post randomization

Study Arms (2)

Automated phone opt-in message

EXPERIMENTAL

Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent

Other: Automated message

Opt-out scheduling

EXPERIMENTAL

Consult automatically sent and Veteran called to schedule screening

Other: Opt-out scheduling

Interventions

Automated messageOTHER

Automated message via phone call (audiocare)

Automated phone opt-in message
Opt-out schedulingOTHER

Scheduling via non-automated phone call

Opt-out scheduling

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale only
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female Veterans aged 45-75
  • assigned to a primary care provider at the VA Puget Sound as of January 1, 2022 with at least 1 year of prior data available
  • due for breast cancer screening (have not had a mammogram in the last 12 months)

You may not qualify if:

  • must not be any indication of current receipt of hospice care
  • no record of recent death in the administrative data
  • not scheduled for either a screening or diagnostic mammogram within the following 12 weeks from assessment.
  • not have a personal history of bilateral mastectomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

Related Publications (1)

  • Marcotte LM, Deeds S, Wheat C, Gunnink E, Gray K, Rojas J, Finch C, Nelson K, Reddy A. Automated Opt-Out vs Opt-In Patient Outreach Strategies for Breast Cancer Screening: A Randomized Clinical Trial. JAMA Intern Med. 2023 Nov 1;183(11):1187-1194. doi: 10.1001/jamainternmed.2023.4321.

    PMID: 37695621DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ashok Reddy, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

  • Stefanie Deeds, MD

    VA Puget Sound Health Care System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stefanie Deeds, MD

CONTACT

206-314-0507Stefanie.Deeds@va.gov

Alaina Mori, MS

CONTACT

206-247-6782Alaina.Mori@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Physician

Study Record Dates

First Submitted

February 1, 2022

First Posted

April 6, 2022

Study Start

April 18, 2022

Primary Completion

August 31, 2022

Study Completion

August 31, 2022

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)