Breast CancerNCT06011434
Testing Conversation Aid in Practice
An observational study of Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 75 to 89 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Mammography Screening Conversation Aid
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 6 May 2024to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 89 years
- Women only
- Healthy volunteers accepted
- Older adult
Study population: Primary care practices at Beth Israel Deaconess Medical Center
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
Official title: 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.
Read the 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) with 100 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, and 36 primary care providers will participant in this research study.
The National Institute on Aging is supporting this research study by providing funding.
- Conditions
- Breast Cancer
- Being tested
- Mammography Screening Conversation Aid
- Keywords
- Breast Cancer, Mammography, Breast Cancer Screening, Mammography Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammography Screening Conversation AidBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mammography Screening Conversation Aid | |
| Clinician: Conversation Aid On Mammography Screening | Clinicians will complete study procedures as follows:
* Pretest questionnaires.
* Post-test questionnaires. Receives: Behavioral: Mammography Screening Conversation Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Secondary outcomes (9)
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." (scores transformed for summary score 0 to 100)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: 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.
Measured: 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."
Measured: 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."
Measured: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2023
- Study start6 May 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mara Schonberg, Beth Israel Deaconess Medical Center
- Investigators
- Mara Schonberg, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06011434
- Sponsor's protocol ID
- 23-201
- Other IDs
- R01AG065311
- Status last verified
- Oct 2026
- First submitted
- 8 Aug 2023
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing a Conversation Aid on Mammography Screening for Clinicians and Women 75 and Older in Practice
- ClinicalTrials.gov ID
- NCT06011434
- Acronym / sponsor ID
- 23-201
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Mammography, Breast Cancer Screening, Mammography Screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 25 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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) with 100 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, and 36 primary care providers will participant in this research study.
The National Institute on Aging is supporting this research study by providing funding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient: Conversation Aid On Mammography Screening | – | Behavioral: Mammography Screening Conversation AidParticipants 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. |
| Family: Conversation Aid On Mammography Screening | – | Behavioral: Mammography Screening Conversation AidCaretakers/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. |
| Clinician: Conversation Aid On Mammography Screening | – | Behavioral: Mammography Screening Conversation AidClinicians will complete study procedures as follows: * Pretest questionnaires. * Post-test questionnaires. |
Who may qualify
- Ages
- 75 to 89 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Primary care practices at Beth Israel Deaconess Medical Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mammography Screening Conversation AidWeb-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. | Behavioural | Clinician: Conversation Aid On Mammography Screening, Family: Conversation Aid On Mammography Screening, Patient: Conversation Aid On Mammography Screening |
Primary outcome
Intentions For Screening Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
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.
9 secondary outcomes
Shared Decision Making (SDM) Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Decisional Conflict Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Role In Decision (Decision Making Preferences Questionnaire)
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Participant Knowledge Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Mammogram Attitudes Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Mammogram Perceived Norms Questionnaire
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.
Clinician Self-Efficacy Scale
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Clinician Attitudes Scale
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Clinician Perceived Norms Scale
Time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 18 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mara Schonberg, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intentions For Screening Questionnaire (time frame: 1-12 weeks for pretest and 1 - 4 weeks for posttest, up to 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.