Clinical trial · Interventional
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Identifying Decision Making Needs for Older Adult Women With Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study collects information and identifies decision making needs for older adult women with stage I-III breast cancer considering neoadjuvant and adjuvant chemotherapy. Using this information, a decision support tool is then developed to provide patients and physicians with tailored information regarding the risks and benefits of chemotherapy and values clarification to support high-quality, shared decision. Subsequently, the decision support tool will be tested amongst older patients with early-stage breast cancer and health care providers navigating the decision process around chemotherapy, and further refined through an iterative process.
Conditions
Conditions (20)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage II Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IIIB Breast Cancer AJCC v8 | — | UNRESOLVED |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Discussion | Other | — | UNRESOLVED |
| Interview | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Intervention Arm
- description
- Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process
- interventionNames
- Other: Discussion
- Other: Interview
- Other: Questionnaire Administration
- type
- NO_INTERVENTION
- label
- Non-Intervention Arm
- description
- Participants undergo interviews and complete questionnaires over 1-2 hours. Patients and physicians also participate in a discussion and complete shared decision-making questionnaire over 15-30 minutes.
Primary outcomes (1)
- measure
- Decision making needs assessment questionnaire
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
INCLUSION CRITERIA: Patient Inclusion Criteria * Women aged 65 years or older * Must write and speak English * Must have been diagnosed with Stage I-III breast cancer * Must have made decision to either receive or not receive neoadjuvant or adjuvant chemotherapy * Must be within 3 months of breast cancer neoadjuvant or adjuvant chemotherapy treatment decision * Self-reported no visual or auditory deficits * SUBAIM 2b: Women aged 65 years or older * SUBAIM 2b: Must write and speak English * SUBAIM 2b: Must have been diagnosed with stage I-III breast cancer * SUBAIM 2b: Must be a candidate for chemotherapy or targeted therapy (in the setting of HER2+ breast cancer) * SUBAIM 2b: Must be making a decision regarding chemotherapy * SUBAIM 2b: Self-reported no visual or auditory deficits * PHYSICIAN INCLUSION CRITERIA * Physician for patient recruited to participate in study (physician criteria) Exclusion Criteria: None
References
Publications (0)
Data not yet available