Testing Conversation Aid in Practice

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06011434
• Other study ID #: 23-201
• Secondary ID: R01AG065311
• Status: Recruiting
• Start date: May 6, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Mara Schonberg, MD, MPH
• Phone: 617-754-1414
• Email: mschonbe[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 157
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 75 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.