- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05821023
Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21224
- Johns Hopkins University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Part of an online survey panel called KnowledgePanel
- able to complete survey in English
Exclusion Criteria:
- Personal history of breast cancer
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group 1 - control (no exposure)
No message at T1 or T2.
|
|
|
Other: Group 2 - control (single exposure)
Single clinician message at T1 aimed at reducing over-screening.
No message at T2.
|
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
|
|
Experimental: Group 3
T1 - message from media source aimed at reducing over-screening.
T2 - message from clinician aimed at reducing over-screening
|
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
|
|
Experimental: Group 4
T1 - message from a close family member aimed at reducing over-screening.
T2 - message from clinician aimed at reducing over-screening
|
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
|
|
Experimental: Group 5
T1 - message from media source aimed at supporting continued screening.
T2 - message from clinician aimed at reducing over-screening
|
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
|
|
Experimental: Group 6
T1 - message from a close family member aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening |
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Immediately after reading the assessment question
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breast cancer screening attitude on mammogram importance as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Attitude toward mammogram importance; assessed by score on a 5 point likert scale question developed by the investigators.
|
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
|
Attitude toward mammogram benefits; assessed by score on a 5 point likert scale question developed by the investigators.
|
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
|
Attitude toward mammogram being worthwhile; assessed by score on a 5 point likert scale question developed by the investigators.
|
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 thinking carefully about getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
|
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 information about the potential benefits of getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
|
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
|
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.
|
Immediately after reading the assessment question
|
|
Breast cancer screening intention for participant assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
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)
|
Immediately after reading the assessment question
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional reaction to message (annoyed) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate the extent of feeling annoyed after reading the message; assessed by a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Emotional reaction to message (interested) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate the extent of feeling interested after reading the message; assessed by a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Emotional reaction to message (worried) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate the extent of feeling worried after reading the message; assessed by a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Emotional reaction to message (reassured) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate the extent of feeling reassured after reading the message; assessed by 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Open ended response to messages assessed by an open ended question
Time Frame: Immediately after reading the assessment question
|
Participants will be asked to state thoughts and ideas when reading the information.
|
Immediately after reading the assessment question
|
|
Potential unintended consequences (discouraged) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate how much the information discouraged wanting to get a mammogram; assessed by score on a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Potential unintended consequences (unpleasant) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate how much the information makes getting a mammogram seem unpleasant; assessed by score on a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Potential unintended consequences (concerned) as assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate concern about the health effects of getting a mammogram; assessed by score on a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Number of participants aware of screening harms (guidelines) as assessed by yes/no question
Time Frame: immediately after reading the assessment question
|
Participants will indicate awareness of medical guidelines concerning women over age 65 who have a lot of health problems, medical guidelines recommend against regular mammograms; assessed by yes/no question developed by the investigators.
|
immediately after reading the assessment question
|
|
Number of participants aware of screening harms (treatments) assessed by yes/no question
Time Frame: Immediately after reading the assessment question
|
Participants will indicate awareness of mammograms that find slow-growing breast cancers that might never cause problems but can lead to unnecessary, risky treatments such as surgery or radiation; assessed by yes/no question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Number of participants aware of screening harms (false alarm results) as assessed by yes/no question
Time Frame: Immediately after reading the assessment question
|
Participants will indicate awareness of mammograms that can have false alarm results that may cause stress, anxiety, and require breast biopsies; assessed by yes/no question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Backlash after exposure to conflicting information (confusion) assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate how confusing mammogram screening recommendations to be; using a 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Backlash after exposure to conflicting information (indecision) assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate whether it is clear or not whether to continue or stop getting mammograms; assessed by 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Backlash after exposure to conflicting information (guidelines) assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate whether medical guidelines provide good advice about mammogram screening; assessed by 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Backlash after exposure to conflicting information (trust) assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate trust in doctors' advice about continuing or stopping getting mammograms; assessed by 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
|
Backlash after exposure to conflicting information (mixed feelings) assessed by score on a scale
Time Frame: Immediately after reading the assessment question
|
Participants will rate having mixed feelings about getting mammograms; assessed by 5 point likert scale question developed by the investigators.
|
Immediately after reading the assessment question
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nancy Schoenborn, MD, Johns Hopkins School of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00283392
- R01AG066741 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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