Breast CancerBREASTChoiceNCT07396766
Dissemination of BREASTChoice AIM1-B
A study testing Baseline Questionnaire, Semi structured Interview and Post Survey in people with Breast Cancer and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Neoplasms
- What is being tested?
- Baseline Questionnaire, Semi structured Interview and Post Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2025to 28 Sep 2026
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of North Carolina
Chapel Hill, North Carolina, 27599
About this study
Official title: Dissemination of a Breast Reconstruction Decision Tool Through Social Media and Online Communities- AIM1-B
This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and reactions. Interviews will include open-ended questions about the content and format of the decision aid, with follow-up prompts to gather feedback on design elements (length, order, graphics), comprehension, ease of use, acceptance, and engagement with the tool. Knowledge will be measured using the Decision Quality Instrument before and after using the tool. Results will be analyzed to develop recommendations for the final version of the tool.
Read the detailed description
This study is part of a larger project that will update and adapt an existing online decision tool called BREASTChoice. The project includes interviews and user testing with breast cancer survivors, interviews with medical experts, and updates to the website design.
Breast reconstruction after a mastectomy is an important part of breast cancer treatment. It can help restore quality of life and body image, which are often affected after surgery. However, many patients, especially those who identify as Black or Hispanic/Latina are not always offered reconstruction. Some patients also lack information about the risks and benefits, leading to choices that may not match their personal preferences.
The BREASTChoice decision aid was created to help patients make informed choices about breast reconstruction. It has been tested in two clinical studies and shown to improve decision quality. Patients and doctors found it helpful and easy to use, but many asked for a version that works better on mobile devices and can be shared with family and friends.
So far, BREASTChoice has mostly been used in clinics and has not reached many people outside of them. To reach more patients, the tool will be adapted for use on social media and online communities, places where many people already go for health information and support.
In the U.S., most adults use social media (about 81%) and search the internet for health information (about 72%). Even most older adults (60%) go online. Breast cancer survivors are especially active in online groups. Early findings show that survivors would use BREASTChoice if it were available through social media.
Following the Designing for Dissemination approach, and in partnership with three cancer survivor organizations and two clinician groups, this project will adapt BREASTChoice and share it through social media and online communities.
- Conditions
- Breast Cancer, Breast Neoplasms
- Being tested
- Baseline Questionnaire, Semi structured Interview, Post Survey
- Keywords
- web-based patient decision aid, BREASTChoice
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline QuestionnaireBehavioural
Participants will be screened and share demographic information during screening. If eligible and screened in, the interviewer will send the self-administered pre-survey Decision Quality Index (DQI).
Semi structured InterviewBehavioural
Participants will participate in a semi-structured interview and review of the adapted BREASTChoice tool.
Post SurveyBehavioural
Participants will take the post-survey to assess breast reconstruction decision quality.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer survivors | Experimental | Breast cancer survivors. Receives: Behavioral: Baseline Questionnaire; Behavioral: Semi structured Interview; Behavioral: Post Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in breast reconstruction knowledge
This is knowledge based patient-reported outcome measure uses the Breast Cancer Reconstruction Decision Quality Instrument (DQI). DQ is a 9-item patient-reported measure designed to assess how well patients are informed about breast reconstruction options following breast cancer treatment. The instrument consists of multiple-choice questions with factual, correct answers related to breast reconstruction. Decision quality is quantified as a knowledge score, reflecting the extent to which patients understand key information necessary to make informed reconstruction decisions.
Scores range from 0% to 100%. The total score is calculated by summing the number of correctly answered items and dividing by the total number of questions (9), with higher scores indicating greater knowledge and higher decision quality.
Measured: Up to1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start1 Oct 2025
- Primary completion28 Sep 2026
- Study completion28 Sep 2026
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.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clara Lee, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07396766
- Sponsor's protocol ID
- 24-1553 AIM1-B
- Other IDs
- R01CA276408
- Acronym
- BREASTChoice
- Status last verified
- Sep 2026
- First submitted
- 2 Feb 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dissemination of a Breast Reconstruction Decision Tool Through Social Media and Online Communities- AIM1-B
- ClinicalTrials.gov ID
- NCT07396766
- Acronym / sponsor ID
- BREASTChoice / 24-1553 AIM1-B
- Conditions
- Breast Cancer, Breast Neoplasms
- Keywords
- web-based patient decision aid, BREASTChoice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 28 Sep 2026 (actual)
- Study completion
- 28 Sep 2026 (actual)
- First posted
- 9 Feb 2026 (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.
This registration covers only Aim 1b, which focuses on testing usability. The study will include 20 participants who are breast cancer patients. Participants will be observed using the tool on their mobile devices, and their experience will be evaluated using a "think-aloud" method to capture their thoughts and reactions. Interviews will include open-ended questions about the content and format of the decision aid, with follow-up prompts to gather feedback on design elements (length, order, graphics), comprehension, ease of use, acceptance, and engagement with the tool. Knowledge will be measured using the Decision Quality Instrument before and after using the tool. Results will be analyzed to develop recommendations for the final version of the tool.
Detailed description
This study is part of a larger project that will update and adapt an existing online decision tool called BREASTChoice. The project includes interviews and user testing with breast cancer survivors, interviews with medical experts, and updates to the website design.
Breast reconstruction after a mastectomy is an important part of breast cancer treatment. It can help restore quality of life and body image, which are often affected after surgery. However, many patients, especially those who identify as Black or Hispanic/Latina are not always offered reconstruction. Some patients also lack information about the risks and benefits, leading to choices that may not match their personal preferences.
The BREASTChoice decision aid was created to help patients make informed choices about breast reconstruction. It has been tested in two clinical studies and shown to improve decision quality. Patients and doctors found it helpful and easy to use, but many asked for a version that works better on mobile devices and can be shared with family and friends.
So far, BREASTChoice has mostly been used in clinics and has not reached many people outside of them. To reach more patients, the tool will be adapted for use on social media and online communities, places where many people already go for health information and support.
In the U.S., most adults use social media (about 81%) and search the internet for health information (about 72%). Even most older adults (60%) go online. Breast cancer survivors are especially active in online groups. Early findings show that survivors would use BREASTChoice if it were available through social media.
Following the Designing for Dissemination approach, and in partnership with three cancer survivor organizations and two clinician groups, this project will adapt BREASTChoice and share it through social media and online communities.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer survivors | Experimental | Behavioral: Baseline Questionnaire, Behavioral: Semi structured Interview, Behavioral: Post SurveyBreast cancer survivors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.
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 |
|---|---|---|
| Baseline QuestionnaireParticipants will be screened and share demographic information during screening. If eligible and screened in, the interviewer will send the self-administered pre-survey Decision Quality Index (DQI). | Behavioural | Breast cancer survivors |
| Semi structured InterviewParticipants will participate in a semi-structured interview and review of the adapted BREASTChoice tool. | Behavioural | Breast cancer survivors |
| Post SurveyParticipants will take the post-survey to assess breast reconstruction decision quality. | Behavioural | Breast cancer survivors |
Primary outcome
Change in breast reconstruction knowledge
Time frame: Up to1 week
This is knowledge based patient-reported outcome measure uses the Breast Cancer Reconstruction Decision Quality Instrument (DQI). DQ is a 9-item patient-reported measure designed to assess how well patients are informed about breast reconstruction options following breast cancer treatment. The instrument consists of multiple-choice questions with factual, correct answers related to breast reconstruction. Decision quality is quantified as a knowledge score, reflecting the extent to which patients understand key information necessary to make informed reconstruction decisions. Scores range from 0% to 100%. The total score is calculated by summing the number of correctly answered items and dividing by the total number of questions (9), with higher scores indicating greater knowledge and higher decision quality.
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 29 Sep 2026.
- UNC Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Clara Lee principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Questionnaire, Semi structured Interview and Post Survey in people with Breast Cancer and Breast Neoplasms, run by UNC Lineberger Comprehensive Cancer 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?
The sponsor lists 0 inclusion and 1 exclusion criteria. 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 29 Sep 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?
Change in breast reconstruction knowledge (time frame: Up to1 week). 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 29 Sep 2026.