Clinical trial NCT05313737: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Keywords: Cancer Screening
Adherence
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
First posted: 2022-04-06
Enrollment: 871
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Percentage of mammograms completed at 100 days post randomization
timeFrame: 100 days post randomization
Secondary outcomes:
measure: Percentage of mammograms scheduled at 100 days post randomization
timeFrame: 100 days post randomization
Other outcomes:
measure: Percentage of mammograms cancelled at 100 days post randomization
timeFrame: 100 days post randomization
measure: Percentage of mammograms active at 100 days post randomization
timeFrame: 100 days post randomization
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System
name: Ashok Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Puget Sound Health Care System
name: Stefanie Deeds, MD
role: PRINCIPAL_INVESTIGATOR
References: