Breast Cancer ScreeningNCT05821023
Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women
A study testing messages in people with Breast Cancer Screening, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is an online survey experiment with data collection over 2 time points two weeks apart. This is Aim 2 of a three-aim R01 project; overall project goal is to better understand how messages from different sources interact to affect older women's breast cancer screening decisions. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Screening
- What is being tested?
- messages
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,173 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to 19 Jun 2023
- 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 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Part of an online survey panel called KnowledgePanel
- able to complete survey in English
Who cannot join
- Personal history of breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
This is an online survey experiment with data collection over 2 time points two weeks apart. This is Aim 2 of a three-aim R01 project; overall project goal is to better understand how messages from different sources interact to affect older women's breast cancer screening decisions. In this current project, the investigators propose to test the effect of combined exposure to a clinician message + a message from another source (i.e. family/friend or media) on older women's breast cancer screening beliefs, attitudes, and intentions.
Read the detailed description
In a two-wave national online survey experiment, the investigators will randomly assign 3,000 women 65 years or older without personal history of breast cancer to 6 groups, including two control groups and four experimental groups. The experimental groups will read a message at Time 1 (T1) that may be from either family/friend or the media followed by a second message from a clinician one to two weeks later at Time 2 (T2).
The clinician message will be directed at reducing over-screening, mentioning the harms of over-screening and supporting screening cessation. The investigators will systematically vary the non-clinician message to be either consistent with the clinician message (also mentions harms of over-screening and supports screening cessation) or conflicting (mentions benefits of screening, supports continued screening and opposes screening cessation). The investigators include a no-exposure control group (Group 1) where the participants read no message at either time point and will only be asked the assessment questions. The investigators also include a single exposure group that reads only the clinician message (Group 2).
- Conditions
- Breast Cancer Screening
- Being tested
- messages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
messagesOther
Different messages describing either the benefits of breast cancer screening aimed at supporting continued screening or messages describing the harms of over-screening and making recommendations to stop screening
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - control (no exposure) | No intervention | No message at T1 or T2. |
| Group 2 - control (single exposure) | Other | Single clinician message at T1 aimed at reducing over-screening. No message at T2. Receives: Other: messages |
| Group 3 | Experimental | T1 - message from media source aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening Receives: Other: messages |
| Group 4 | Experimental | T1 - message from a close family member aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening Receives: Other: messages |
| Group 5 | Experimental | T1 - message from media source aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening Receives: Other: messages |
| Group 6 | Experimental | T1 - message from a close family member aimed at supporting continued screening.
T2 - message from clinician aimed at reducing over-screening Receives: Other: messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Support for stopping screening for a hypothetical patient in survey vignette assessed by score on a scale
Screening intention for a hypothetical patient; assessed by score on a 7 point likert scale question developed by the investigators. 7= definitely should not get a mammogram (i.e. strong support for stopping screening) 1=definitely should get a mammogram (i.e. weak support for stopping screening)
Measured: Immediately after reading the assessment question
Secondary outcomes (7)
Breast cancer screening intention for participant assessed by score on a scale
Screening intention assessed by score on a 7 point likert scale question developed by the investigators. 7= very unlikely to get a mammogram (i.e. high intention to stop screening); 1= very likely to get a mammogram (i.e. low intention to stop screening)
Measured: Immediately after reading the assessment question
Breast cancer screening attitude on mammogram importance as assessed by score on a scale
Attitude toward mammogram importance; assessed by score on a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Breast cancer screening attitude on benefits of mammograms as assessed by score on a scale
Attitude toward mammogram benefits; assessed by score on a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Breast cancer screening attitude on mammogram being worthwhile as assessed by score on a scale
Attitude toward mammogram being worthwhile; assessed by score on a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Message effectiveness toward thinking about getting a mammogram as assessed by score on a scale
Message effectiveness toward thinking carefully about getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Message effectiveness toward finding out more about the benefits of a mammogram as assessed by score on a scale
Message effectiveness toward finding out more information about the potential benefits of getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Message effectiveness toward finding out more about downsides of getting a mammogram as assessed by score on a scale
Message effectiveness toward finding out more information about the potential downsides of getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
Measured: Immediately after reading the assessment question
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start12 May 2023
- Primary completion19 Jun 2023
- Study completion19 Jun 2023
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 Cancer ScreeningStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota, Beth Israel Deaconess Medical Center, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Nancy Schoenborn, MD, Principal investigator, Johns Hopkins School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05821023
- Sponsor's protocol ID
- IRB00283392
- Other IDs
- R01AG066741
- Status last verified
- Feb 2024
- First submitted
- 4 Apr 2023
- Last updated
- 14 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schoenborn NL, Gollust SE, Nagler RH, Pollack CE, Boyd CM, Xue QL, Schonberg MA. Effect of Messaging on Support for Breast Cancer Screening Cessation Among Older US Women: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428700. doi: 10.1001/jamanetworkopen.2024.28700.
PubMed 39158912
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women
- ClinicalTrials.gov ID
- NCT05821023
- Acronym / sponsor ID
- IRB00283392
- Conditions
- Breast Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,173 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Minnesota, Beth Israel Deaconess Medical Center, National Institute on Aging (NIA)
- Study start
- 12 May 2023 (actual)
- Primary completion
- 19 Jun 2023 (actual)
- Study completion
- 19 Jun 2023 (actual)
- First posted
- 20 Apr 2023 (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 an online survey experiment with data collection over 2 time points two weeks apart. This is Aim 2 of a three-aim R01 project; overall project goal is to better understand how messages from different sources interact to affect older women's breast cancer screening decisions. In this current project, the investigators propose to test the effect of combined exposure to a clinician message + a message from another source (i.e. family/friend or media) on older women's breast cancer screening beliefs, attitudes, and intentions.
Detailed description
In a two-wave national online survey experiment, the investigators will randomly assign 3,000 women 65 years or older without personal history of breast cancer to 6 groups, including two control groups and four experimental groups. The experimental groups will read a message at Time 1 (T1) that may be from either family/friend or the media followed by a second message from a clinician one to two weeks later at Time 2 (T2).
The clinician message will be directed at reducing over-screening, mentioning the harms of over-screening and supporting screening cessation. The investigators will systematically vary the non-clinician message to be either consistent with the clinician message (also mentions harms of over-screening and supports screening cessation) or conflicting (mentions benefits of screening, supports continued screening and opposes screening cessation). The investigators include a no-exposure control group (Group 1) where the participants read no message at either time point and will only be asked the assessment questions. The investigators also include a single exposure group that reads only the clinician message (Group 2).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1 - control (no exposure) | No intervention | –No message at T1 or T2. |
| Group 2 - control (single exposure) | Other | Other: messagesSingle clinician message at T1 aimed at reducing over-screening. No message at T2. |
| Group 3 | Experimental | Other: messagesT1 - message from media source aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening |
| Group 4 | Experimental | Other: messagesT1 - message from a close family member aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening |
| Group 5 | Experimental | Other: messagesT1 - message from media source aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening |
| Group 6 | Experimental | Other: messagesT1 - message from a close family member aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Part of an online survey panel called KnowledgePanel
- able to complete survey in English
Key exclusion criteria (1 listed)
- Personal history of breast cancer
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 |
|---|---|---|
| messagesDifferent messages describing either the benefits of breast cancer screening aimed at supporting continued screening or messages describing the harms of over-screening and making recommendations to stop screening | Other | Group 2 - control (single exposure), Group 3, Group 4, Group 5, Group 6 |
Primary outcome
Support for stopping screening for a hypothetical patient in survey vignette assessed by score on a scale
Time frame: Immediately after reading the assessment question
Screening intention for a hypothetical patient; assessed by score on a 7 point likert scale question developed by the investigators. 7= definitely should not get a mammogram (i.e. strong support for stopping screening) 1=definitely should get a mammogram (i.e. weak support for stopping screening)
7 secondary outcomes
Breast cancer screening intention for participant assessed by score on a scale
Time frame: Immediately after reading the assessment question
Breast cancer screening attitude on mammogram importance as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Breast cancer screening attitude on benefits of mammograms as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Breast cancer screening attitude on mammogram being worthwhile as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Message effectiveness toward thinking about getting a mammogram as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Message effectiveness toward finding out more about the benefits of a mammogram as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Message effectiveness toward finding out more about downsides of getting a mammogram as assessed by score on a scale
Time frame: Immediately after reading the assessment question
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2024.
- Derived from this study: PubMed 39158912Schoenborn NL, Gollust SE, Nagler RH, Pollack CE, Boyd CM, Xue QL, Schonberg MA. Effect of Messaging on Support for Breast Cancer Screening Cessation Among Older US Women: A Randomized Clinical Trial. JAMA Netw Open. 2024 Aug 1;7(8):e2428700. doi: 10.1001/jamanetworkopen.2024.28700.
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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.
Nancy Schoenborn, MD principal investigator
Johns Hopkins School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing messages in people with Breast Cancer Screening, run by Johns Hopkins University 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 2 inclusion and 1 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: finished, as of the sponsor's last update on 14 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Support for stopping screening for a hypothetical patient in survey vignette assessed by score on a scale (time frame: Immediately after reading the assessment question). 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 NCT05821023, 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 14 Feb 2024.