To hear about similar clinical trials, please enter your email below
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