Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women

February 12, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Intervention / Treatment

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

Interventional

Enrollment (Actual)

4173

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nancy Schoenborn, MD, Johns Hopkins School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2023

Primary Completion (Actual)

June 19, 2023

Study Completion (Actual)

June 19, 2023

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 4, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

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

No

Studies a U.S. FDA-regulated device product

No

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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