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

Breast Cancer Screening Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05821023
• Other study ID #: IRB00283392
• Secondary ID: R01AG066741
• Status: Completed
• Phase: N/A
• Start date: May 12, 2023
• Est. completion date: June 19, 2023

Study information

• Verified date: February 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4173
• Est. completion date: June 19, 2023
• Est. primary completion date: June 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Part of an online survey panel called KnowledgePanel

• able to complete survey in English

Exclusion Criteria:

• Personal history of breast cancer

Related Conditions & MeSH terms

• Breast Cancer Screening
• Breast Neoplasms

Intervention

Other:
• messages
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

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins University	Beth Israel Deaconess Medical Center, National Institute on Aging (NIA), University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional reaction to message (annoyed) as assessed by score on a scale	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
Other	Emotional reaction to message (interested) as assessed by score on a scale	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
Other	Emotional reaction to message (worried) as assessed by score on a scale	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
Other	Emotional reaction to message (reassured) as assessed by score on a scale	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
Other	Open ended response to messages assessed by an open ended question	Participants will be asked to state thoughts and ideas when reading the information.	Immediately after reading the assessment question
Other	Potential unintended consequences (discouraged) as assessed by score on a scale	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
Other	Potential unintended consequences (unpleasant) as assessed by score on a scale	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
Other	Potential unintended consequences (concerned) as assessed by score on a scale	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
Other	Number of participants aware of screening harms (guidelines) as assessed by yes/no 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
Other	Number of participants aware of screening harms (treatments) assessed by yes/no 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
Other	Number of participants aware of screening harms (false alarm results) as assessed by yes/no 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
Other	Backlash after exposure to conflicting information (confusion) assessed by score on a scale	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
Other	Backlash after exposure to conflicting information (indecision) assessed by score on a scale	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
Other	Backlash after exposure to conflicting information (guidelines) assessed by score on a scale	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
Other	Backlash after exposure to conflicting information (trust) assessed by score on a scale	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
Other	Backlash after exposure to conflicting information (mixed feelings) assessed by score on a scale	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
Primary	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)	Immediately after reading the assessment question
Secondary	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)	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question
Secondary	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.	Immediately after reading the assessment question