Clinical trial · Interventional
Dissemination of BREASTChoice AIM1-B
Dissemination of a Breast Reconstruction Decision Tool Through Social Media and Online Communities- AIM1-B
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline Questionnaire | Behavioral | — | UNRESOLVED |
| Post Survey | Behavioral | — | UNRESOLVED |
| Semi structured Interview | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast cancer survivors
- description
- Breast cancer survivors.
- interventionNames
- Behavioral: Baseline Questionnaire
- Behavioral: Semi structured Interview
- Behavioral: Post Survey
Primary outcomes (1)
- measure
- Change in breast reconstruction knowledge
- timeFrame
- Up to1 week
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusions Criteria To participate in this study, a subject must meet all the eligibility criteria outlined below. * Age ≥ 18 years at the time of consent * Able to read and speak English. * Have had surgery, such as a mastectomy or lumpectomy, to remove some or all of their breast or breasts. * Breast surgery occurred within the past 8 years. * Breast surgery was due to a diagnosis of breast cancer, ductal carcinoma in situ, or risk of future breast cancer, by participant report. * Sex was assigned "Female" at birth Exclusion Criteria • Individuals with self-reported or observed unstable medical or psychiatric conditions precluding informed consent or participation in the study will be excluded.
References
Publications (0)
Data not yet available