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Trial Title: Testing Conversation Aid in Practice

NCT ID: NCT06011434

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Breast Cancer
Mammography
Breast Cancer Screening
Mammography Screening

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Behavioral
Intervention name: Mammography Screening Conversation Aid
Description: 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.
Arm group label: Clinician: Conversation Aid On Mammography Screening
Arm group label: Family: Conversation Aid On Mammography Screening
Arm group label: Patient: Conversation Aid On Mammography Screening

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.

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.

Criteria for eligibility:

Study pop:
Primary care practices at Beth Israel Deaconess Medical Center

Sampling method: Non-Probability Sample
Criteria:
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

Gender: Female

Gender based: Yes

Minimum age: 75 Years

Maximum age: 89 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Mara Schonberg, MD, MPH

Phone: 617-754-1414
Email: mschonbe@bidmc.harvard.edu

Investigator:
Last name: Mara Schonberg, MD, MPH
Email: Principal Investigator

Start date: May 6, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Beth Israel Deaconess Medical Center
Agency class: Other

Collaborator:
Agency: National Institute on Aging (NIA)
Agency class: NIH

Source: Beth Israel Deaconess Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06011434

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