NCT05821023

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,173

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 4, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

April 20, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

May 12, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2023

Completed
Last Updated

February 14, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

April 4, 2023

Last Update Submit

February 12, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Breast cancer screening intention for participant assessed by score on a scale

    Immediately after reading the assessment question

  • Breast cancer screening attitude on mammogram importance as assessed by score on a scale

    Immediately after reading the assessment question

  • Breast cancer screening attitude on benefits of mammograms as assessed by score on a scale

    Immediately after reading the assessment question

  • Breast cancer screening attitude on mammogram being worthwhile as assessed by score on a scale

    Immediately after reading the assessment question

  • Message effectiveness toward thinking about getting a mammogram as assessed by score on a scale

    Immediately after reading the assessment question

  • +2 more secondary outcomes

Other Outcomes (16)

  • Emotional reaction to message (annoyed) as assessed by score on a scale

    Immediately after reading the assessment question

  • Emotional reaction to message (interested) as assessed by score on a scale

    Immediately after reading the assessment question

  • Emotional reaction to message (worried) as assessed by score on a scale

    Immediately after reading the assessment question

  • +13 more other outcomes

Study Arms (6)

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.

Other: messages

Group 3

EXPERIMENTAL

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

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

Other: messages

Group 5

EXPERIMENTAL

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

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

Other: messages

Interventions

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

Group 2 - control (single exposure)Group 3Group 4Group 5Group 6

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Part of an online survey panel called KnowledgePanel
  • able to complete survey in English

You may not qualify if:

  • Personal history of breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Nancy Schoenborn, MD

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants will be randomly assigned to one of six study groups
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 20, 2023

Study Start

May 12, 2023

Primary Completion

June 19, 2023

Study Completion

June 19, 2023

Last Updated

February 14, 2024

Record last verified: 2024-02

Locations