Clinical trial · Interventional
A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older
NCT02823262CI-TRIAL-00072763terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Did not receive funding for the trial.
Summary
Brief summary (as posted)
The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.
Conditions
Conditions (4)
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 |
| Estrogen Receptor Positive Breast Cancer | — | UNRESOLVED | — |
| Human Epidermal Growth Factor 2 Negative Carcinoma of Breast | — | UNRESOLVED | — |
| Node-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Treatment Decision Aid for women 70+ | Other | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Decision Aid
- description
- Post Initial Surgical Consultation * Including background questionnaire and randomization into Decision Aid Group or Control Group: * The Decision Aid Group (workbook and CD) explains each treatment including its benefits and risks. \-- The DA asks women 10 questions about their health;the response to each question is associated with a point value and women are asked to tally their points. The DA groups women into 4 health categories based on their health score. * Assessment at One week after participants surgical consultation and five months after surgical consultation
- interventionNames
- Other: Breast Cancer Treatment Decision Aid for women 70+
- type
- ACTIVE_COMPARATOR
- label
- No Decision Aid
- description
- Post Initial Surgical Consultation * Including background questionnaire and randomization into Decision Aid Group or Control Group: * Participant will receive Usual Care assistance when making treatment decisions. * Assessment at One week after participants surgical consultation and five months after surgical consultation
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Phase I * Patient age ≥ 70 yrs * Female patient diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer \>6 months ago but \<2 years ago * Caregiver age \>21 years * English speaking * Phase II * Female patient age ≥ 70 yrs newly diagnosed with a first primary ER+, HER2-, LN-, 3cm or less breast cancer * Women newly diagnosed with breast cancer on the day of surgical consult Exclusion Criteria: * Phase I * Patient Age \< 70 years * Women diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor * Signs of Dementia * Score \>10 on the Orientation-Memory-Concentration (OMC) test * Non-English Speaking; * Caregiver age \< 21 years * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded. * Phase II * Women with a history of breast cancer (invasive and non-invasive) * Diagnosed with Paget's disease, inflammatory breast cancer or a phyllodes tumor * Signs of Dementia * Score \>10 on the OMC test (indicative of dementia). * Women who do not have capacity to participate. --- Before enrolling women in this study, possible participants will be asked 7 questions about the benefits and risks of the study. Women that answer 3 or more of these questions incorrectly will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.