Testing Conversation Aid in Practice

Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice

The goal of this research study is to develop and test a website to help primary care providers (PCPs) discuss the pros and cons of mammography with women aged 75 and older and to help participants make decisions about mammography.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Mammography Screening Conversation Aid

Detailed Description

This research study is to conduct a pilot pretest-posttest trial to learn if providing a web-based conversation aid (CA) on mammography screening to 36 primary care providers facilitates shared decision making (SDM) and 8 medical assistants with 190 of their patients (2-3 per PCP) aged 75-89 years and 23 involved family members.

Research procedures include screening for eligibility, questionnaires, and clinic visits.

Participation in this research study is expected to last about 4 months.

It is expected about 90 participants, 23 participant family members, 36 primary care providers, and 8 medical assistants will participant in this research study.

The National Institute on Aging is supporting this research study by providing funding.

• Study Type: Observational
• Enrollment (Actual): 155

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Primary care practices at Beth Israel Deaconess Medical Center

Description

Participant Inclusion Criteria:

• English-speaking
• Aged 75 - 89 years
• Seen by an attending-level (non-resident) seen at the recruitment practices who have the -Ability and willingness to provide verbal consent.

Participant Family Members Inclusion Criteria:

• Family member of patient that has agreed to participate in the study
• Age >18
• English speaking
• Ability and willingness to provide verbal consent

Primary Care Provider Inclusion Criteria:

• Non-resident physician, nurse practitioner, or physician assistant

  ->18 years old

• English speaking
• Cares for a panel of patients that includes women >75 years at one of the recruitment practices
• Ability and willingness to provide verbal consent

Participant Exclusion Criteria:

• Last mammogram <6 or >30 months (so that participants may be contemplative of their next mammogram)
• History of dementia
• Incapacity for informed consent
• History of invasive or non-invasive breast cancer
• Last mammogram was abnormal
• Non-English speaking
• Already chose to stop being screened (documented in medical records or scores of 1-3 [do not intend to be screened] on a validate 15 point intentions to be screened scale.)
• PCP unwilling to have patient participate
• In hospice
• PCP not willing to participate
• Psychiatric illness situations that would limit compliance with study requirements

Participant Family Member Exclusion Criteria:

• Age <18
• Non-English speaking
• Psychiatric illness situations that would limit compliance with study requirements

Primary Care Provider Exclusion Criteria:

• Resident physician
• Psychiatric illness situations that would limit compliance with study requirements

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient: Conversation Aid On Mammography Screening; Participants will complete study procedures as follows: Pretest questionnaires.; PCP Appointment with introduction to conversation aid website.; Post-test questionnaires within two weeks of PCP visit.	Behavioral: Mammography Screening Conversation Aid; Web-based, "Decide Together" conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.
Family: Conversation Aid On Mammography Screening; Caretakers/Family members to participants will complete study procedures as follows: Pretest questionnaires.; Attend with participant PCP Appointment with introduction to conversation aid website.; Post-test questionnaires within two weeks of PCP visit.	Behavioral: Mammography Screening Conversation Aid; Web-based, "Decide Together" conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.
Clinician: Conversation Aid On Mammography Screening; Clinicians will complete study procedures as follows: Pretest questionnaires.; Post-test questionnaires.	Behavioral: Mammography Screening Conversation Aid; Web-based, "Decide Together" conversation aid designed to be used by PCP and participant for shared decision making and to provide information on the benefits and harms of mammography screening as well as educational talking points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intentions For Screening Questionnaire	Assessed by the Intentions for Screening questionnaire, a 15-point validated measure (1 to 15) to assess one's leaning towards an option with scores of 1=no, 8= unsure, and 15=yes.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared Decision Making (SDM) Questionnaire	Assessed by the validated, 9-item SDM questionnaire. Each item will be scored on a 6-point Likert scale with answers ranging from 0 "completely disagree" to 6 "completely agree." A total score will range from 9 - 54.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Decisional Conflict Questionnaire	Assessed by the Decisional Conflict Questionnaire, a validated, 16 item scale scored on a 5-point Likert scale. Answers range from 1 "Strongly Agree" to 0 "Neutral" to 4 " Strongly Agree" with each score ranging from 0 - 4 points. A total is calculated by [sum of scores/16] x 25=scale 0-100).	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Role In Decision (Decision Making Preferences Questionnaire)	Controlled preferences scale Assessed by the Decision Making Preferences questionnaire which includes 5 response categories (see comments). We will group the 5-items into 3 categories (patient prefers to make the decision, patient prefers the PCP makes the final decision, the patient prefers to share the decision with the PCP). This scale is commonly used to assess a participant's preferred involvement in decision making.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Participant Knowledge Questionnaire	Assessed by the participant knowledge questionnaire, comprised of 10 True/False questions. Total score will be reported as a mean percentage of the number of questions answered correctly.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Mammogram Attitudes Questionnaire	Assessed by the mammogram attitudes questionnaire, comprised of 3 questions graded on a 7-point Likert scale with answers ranging from 1 "Completely Unnecessary/Harmful/Unpleasant" to 7 "Completely Necessary/Beneficial/Pleasant. Scores will be summed and a total score will range from 3 - 21.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Mammogram Perceived Norms Questionnaire	Assessed by the mammogram norms questionnaire, comprised of 2 questions graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree" to 7 "Strongly Agree." Scores will be summed and a total score will range from 2 - 14.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Clinician Self-Efficacy Scale	Assessed by the clinician self-efficacy subscale of the Shared Decision Making (SDM) Questionnaire, which measures clinician self-efficacy to engage older women in shared decision making around mammography screening and is comprised of 5 questions graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree/Easy" to 7 "Strongly Agree/Difficult." A total score will range from 5 to 35.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Clinician Attitudes Scale	Assessed by the clinician attitudes Subscale of the Share Decision Making (SDM Questionnaire which is comprised of 4 questions about clinician attitudes towards mammography screening and graded on a 7-point Likert scale with scores ranging from "1 "Unnecessary/Harmful/Unpleasant/Worthless" to 7 "Necessary/Beneficial/Pleasant/Useful." A total score will range from 4 - 28.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Clinician Perceived Norms Scale	Assessed by the clinician perceived norms subscale of the Shared Decision Making (SDM) Questionnaire which is comprised of 4 questions about clinician perceived norms around mammography screening and graded on a 7-point Likert scale with answers ranging from 1 "Strongly Disagree" to 7 "Strongly Agree." A total score will range from 4 - 28.	1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Mara Schonberg, MD, MPH, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): December 31, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: August 8, 2023
• First Submitted That Met QC Criteria: August 24, 2023
• First Posted (Actual): August 25, 2023

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Breast Cancer Screening; Mammography; Mammography Screening
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 23-201; R01AG065311 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No