Breast CancerNCT05313737
Opt-in vs. Opt-out for Breast Cancer Screening
A study testing Automated message and Opt-out scheduling in people with Breast Cancer, run by VA Puget Sound Health Care System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Automated message and Opt-out scheduling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 871 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Puget Sound Health Care System
Seattle, Washington, 98108
About this study
Official title: Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Automated message, Opt-out scheduling
- Keywords
- Cancer Screening, Adherence
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated messageOther
Automated message via phone call (audiocare)
Opt-out schedulingOther
Scheduling via non-automated phone call
| Study group | Role | What they receive |
|---|---|---|
| Automated phone opt-in message | Experimental | Audiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent Receives: Other: Automated message |
| Opt-out scheduling | Experimental | Consult automatically sent and Veteran called to schedule screening Receives: Other: Opt-out scheduling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of mammograms completed at 100 days post randomization
Percent of mammograms completed
Measured: 100 days post randomization
Secondary outcomes (1)
Percentage of mammograms scheduled at 100 days post randomization
Percent of mammograms scheduled
Measured: 100 days post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start18 Apr 2022 (estimated)
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 871 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Puget Sound Health Care System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Alaina Mori, VA Puget Sound Health Care System
- Investigators
- Ashok Reddy, MD, Principal investigator, VA Puget Sound Health Care SystemStefanie Deeds, MD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313737
- Sponsor's protocol ID
- MAMMoutreach
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37695621
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Opt-in vs. Opt-out Mammography Screening Outreach: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05313737
- Acronym / sponsor ID
- MAMMoutreach
- Conditions
- Breast Cancer
- Keywords
- Cancer Screening, Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 871 participants (estimated)
- Lead sponsor
- VA Puget Sound Health Care SystemUS federal agency
- Study start
- 18 Apr 2022 (estimated)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Automated phone opt-in message | Experimental | Other: Automated messageAudiocare message requiring Veteran to confirm that they would like to participate in screening and have consult sent |
| Opt-out scheduling | Experimental | Other: Opt-out schedulingConsult automatically sent and Veteran called to schedule screening |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated messageAutomated message via phone call (audiocare) | Other | Automated phone opt-in message |
| Opt-out schedulingScheduling via non-automated phone call | Other | Opt-out scheduling |
Primary outcome
Percentage of mammograms completed at 100 days post randomization
Time frame: 100 days post randomization
Percent of mammograms completed
1 secondary outcome
Percentage of mammograms scheduled at 100 days post randomization
Time frame: 100 days post randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 37695621Marcotte 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashok Reddy, MD principal investigator
VA Puget Sound Health Care System
Stefanie Deeds, MD principal investigator
VA Puget Sound Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated message and Opt-out scheduling in people with Breast Cancer, run by VA Puget Sound Health Care System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Deeds, MD (206-314-0507, Stefanie.Deeds@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of mammograms completed at 100 days post randomization (time frame: 100 days post randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05313737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.