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Spots Global Cancer Trial Database for Opt-in vs. Opt-out for Breast Cancer Screening

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Trial Identification

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 ID: NCT05313737

Conditions

Breast Cancer

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.

Eligibility

Minimum Age: 45 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

VA Puget Sound Health Care System, Seattle, Washington, United States

Contact Details

Name: Ashok Reddy, MD

Affiliation: VA Puget Sound Health Care System

Role: PRINCIPAL_INVESTIGATOR

Name: Stefanie Deeds, MD

Affiliation: VA Puget Sound Health Care System

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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