Testing Conversation Aid in Practice

NCT06011434 | Completed

• 2 other identifiers: 23-201R01AG065311
• Study Type: observational
• Target: 155
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Mammography; Breast Cancer Screening; Mammography Screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Shared Decision Making (SDM) Questionnaire

  1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

• Decisional Conflict Questionnaire

  1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

• Role In Decision (Decision Making Preferences Questionnaire)

  1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

• Participant Knowledge Questionnaire

  1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

• Mammogram Attitudes Questionnaire

  1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.

Study Arms (3)

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

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

Clinician: Conversation Aid On Mammography Screening

Clinicians will complete study procedures as follows: * Pretest questionnaires. * Post-test questionnaires.

Behavioral: Mammography Screening Conversation Aid

Interventions

Mammography Screening Conversation Aid BEHAVIORAL

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; Family: Conversation Aid On Mammography Screening; Patient: Conversation Aid On Mammography Screening

Eligibility Criteria

• Age: 75 Years - 89 Years
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care practices at Beth Israel Deaconess Medical Center

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mara Schonberg, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 25, 2023
• Study Start: May 6, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu

Locations

US (1)