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

Primary Purpose

Breast Cancer Screening

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
messages
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer Screening

Eligibility Criteria

65 Years - undefined (Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Part of an online survey panel called KnowledgePanel able to complete survey in English Exclusion Criteria: Personal history of breast cancer

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

No Intervention

Other

Experimental

Experimental

Experimental

Experimental

Arm Label

Group 1 - control (no exposure)

Group 2 - control (single exposure)

Group 3

Group 4

Group 5

Group 6

Arm Description

No message at T1 or T2.

Single clinician message at T1 aimed at reducing over-screening. No message at T2.

T1 - message from media source aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening

T1 - message from a close family member aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening

T1 - message from media source aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening

T1 - message from a close family member aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening

Outcomes

Primary Outcome Measures

Breast cancer screening intention 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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
April 4, 2023
Last Updated
July 12, 2023
Sponsor
Johns Hopkins University
Collaborators
University of Minnesota, Beth Israel Deaconess Medical Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05821023
Brief Title
Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women
Official Title
Messaging Strategies to Reduce Breast Cancer Over-screening in Older Women
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
May 12, 2023 (Actual)
Primary Completion Date
June 19, 2023 (Actual)
Study Completion Date
June 19, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Minnesota, Beth Israel Deaconess Medical Center, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Participants will be randomly assigned to one of six study groups
Allocation
Randomized
Enrollment
4173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 1 - control (no exposure)
Arm Type
No Intervention
Arm Description
No message at T1 or T2.
Arm Title
Group 2 - control (single exposure)
Arm Type
Other
Arm Description
Single clinician message at T1 aimed at reducing over-screening. No message at T2.
Arm Title
Group 3
Arm Type
Experimental
Arm Description
T1 - message from media source aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening
Arm Title
Group 4
Arm Type
Experimental
Arm Description
T1 - message from a close family member aimed at reducing over-screening. T2 - message from clinician aimed at reducing over-screening
Arm Title
Group 5
Arm Type
Experimental
Arm Description
T1 - message from media source aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening
Arm Title
Group 6
Arm Type
Experimental
Arm Description
T1 - message from a close family member aimed at supporting continued screening. T2 - message from clinician aimed at reducing over-screening
Intervention Type
Other
Intervention Name(s)
messages
Intervention Description
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
Primary Outcome Measure Information:
Title
Breast cancer screening intention for a hypothetical patient in survey vignette assessed by score on a scale
Description
Screening intention for a hypothetical patient; assessed by score on a 7 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Breast cancer screening intention for participant assessed by score on a scale
Description
Screening intention assessed by score on a 7 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Secondary Outcome Measure Information:
Title
Breast cancer screening attitude on mammogram importance as assessed by score on a scale
Description
Attitude toward mammogram importance; assessed by score on a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Breast cancer screening attitude on benefits of mammograms as assessed by score on a scale
Description
Attitude toward mammogram benefits; assessed by score on a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Breast cancer screening attitude on mammogram being worthwhile as assessed by score on a scale
Description
Attitude toward mammogram being worthwhile; assessed by score on a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Message effectiveness toward thinking about getting a mammogram as assessed by score on a scale
Description
Message effectiveness toward thinking carefully about getting a mammogram; assessed by a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Message effectiveness toward finding out more about the benefits of a mammogram as assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Message effectiveness toward finding out more about downsides of getting a mammogram as assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Other Pre-specified Outcome Measures:
Title
Emotional reaction to message (annoyed) as assessed by score on a scale
Description
Participants will rate the extent of feeling annoyed after reading the message; assessed by a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Emotional reaction to message (interested) as assessed by score on a scale
Description
Participants will rate the extent of feeling interested after reading the message; assessed by a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Emotional reaction to message (worried) as assessed by score on a scale
Description
Participants will rate the extent of feeling worried after reading the message; assessed by a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Emotional reaction to message (reassured) as assessed by score on a scale
Description
Participants will rate the extent of feeling reassured after reading the message; assessed by 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Open ended response to messages assessed by an open ended question
Description
Participants will be asked to state thoughts and ideas when reading the information.
Time Frame
Immediately after reading the assessment question
Title
Potential unintended consequences (discouraged) as assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Potential unintended consequences (unpleasant) as assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Potential unintended consequences (concerned) as assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Number of participants aware of screening harms (guidelines) as assessed by yes/no question
Description
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.
Time Frame
immediately after reading the assessment question
Title
Number of participants aware of screening harms (treatments) assessed by yes/no question
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Number of participants aware of screening harms (false alarm results) as assessed by yes/no question
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Backlash after exposure to conflicting information (confusion) assessed by score on a scale
Description
Participants will rate how confusing mammogram screening recommendations to be; using a 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Backlash after exposure to conflicting information (indecision) assessed by score on a scale
Description
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.
Time Frame
Immediately after reading the assessment question
Title
Backlash after exposure to conflicting information (guidelines) assessed by score on a scale
Description
Participants will rate whether medical guidelines provide good advice about mammogram screening; assessed by 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Backlash after exposure to conflicting information (trust) assessed by score on a scale
Description
Participants will rate trust in doctors' advice about continuing or stopping getting mammograms; assessed by 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question
Title
Backlash after exposure to conflicting information (mixed feelings) assessed by score on a scale
Description
Participants will rate having mixed feelings about getting mammograms; assessed by 5 point likert scale question developed by the investigators.
Time Frame
Immediately after reading the assessment question

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Part of an online survey panel called KnowledgePanel able to complete survey in English Exclusion Criteria: Personal history of breast cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Schoenborn, MD
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States

12. IPD Sharing Statement

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

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