Opt-in vs. Opt-out for Breast Cancer Screening
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Automated message
Opt-out scheduling
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer focused on measuring Cancer Screening, Adherence
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Sites / Locations
- VA Puget Sound Health Care System
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Automated phone opt-in message
Opt-out scheduling
Arm Description
Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent
Consult automatically sent and Veteran called to schedule screening
Outcomes
Primary Outcome Measures
Percentage of mammograms completed at 100 days post randomization
Percent of mammograms completed
Secondary Outcome Measures
Percentage of mammograms scheduled at 100 days post randomization
Percent of mammograms scheduled
Full Information
NCT ID
NCT05313737
First Posted
February 1, 2022
Last Updated
April 5, 2022
Sponsor
VA Puget Sound Health Care System
1. Study Identification
Unique Protocol Identification Number
NCT05313737
Brief Title
Opt-in vs. Opt-out for Breast Cancer Screening
Official Title
Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 18, 2022 (Anticipated)
Primary Completion Date
August 31, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Puget Sound Health Care System
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 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.
Detailed Description
This is a prospective, randomized controlled trial that will evaluate the effectiveness of two different outreach strategies in improving adherence to breast cancer screening via mammography.
Average risk female Veterans who are due for breast cancer screening (defined as aged 45-75 with no previous history of bilateral mastectomy, not under hospice care, and alive at the time of screening) will be identified through administrative data.
Veterans eligible for enrollment into the trial will be randomized in a 1:1 allocation using permuted block randomization (with random block sizes of 2 and 4) to the following interventions:
Arm 1: Automated phone opt-in message Intervention Type: Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Arm 2: Opt-out scheduling Intervention Type: Consult automatically sent and Veteran called to schedule screening
Randomization will be stratified within arms by prior screening status (prior screener vs. never screener).
The study's primary outcome of interest is screening completion at 100 days post randomization. The study's secondary outcome of interest is screening scheduling at 100 days post randomization. Subgroup analysis aim 1 will explore whether the differences in breast cancer screening completion between investigational groups varies according to the Veterans' race/ethnicity. Subgroup analysis aim 2 will explore whether the differences in breast cancer screening scheduling between investigational groups varies according to the Veterans' race/ethnicity. Enrollment in the trial will occur between March 1, 2022 and August 31, 2022.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cancer Screening, Adherence
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
871 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Automated phone opt-in message
Arm Type
Experimental
Arm Description
Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent
Arm Title
Opt-out scheduling
Arm Type
Experimental
Arm Description
Consult automatically sent and Veteran called to schedule screening
Intervention Type
Other
Intervention Name(s)
Automated message
Intervention Description
Automated message via phone call (audiocare)
Intervention Type
Other
Intervention Name(s)
Opt-out scheduling
Intervention Description
Scheduling via non-automated phone call
Primary Outcome Measure Information:
Title
Percentage of mammograms completed at 100 days post randomization
Description
Percent of mammograms completed
Time Frame
100 days post randomization
Secondary Outcome Measure Information:
Title
Percentage of mammograms scheduled at 100 days post randomization
Description
Percent of mammograms scheduled
Time Frame
100 days post randomization
Other Pre-specified Outcome Measures:
Title
Percentage of mammograms cancelled at 100 days post randomization
Description
Percent of mammograms cancelled
Time Frame
100 days post randomization
Title
Percentage of mammograms active at 100 days post randomization
Description
Percent of mammograms active
Time Frame
100 days post randomization
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female only
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stefanie Deeds, MD
Phone
206-314-0507
Email
Stefanie.Deeds@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Alaina Mori, MS
Phone
206-247-6782
Email
Alaina.Mori@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashok Reddy, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stefanie Deeds, MD
Organizational Affiliation
VA Puget Sound Health Care System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Opt-in vs. Opt-out for Breast Cancer Screening
We'll reach out to this number within 24 hrs