Helping older women with breast cancer make chemotherapy decisions
Identifying Decision Making Needs for Older Adult Women with Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
NA · M.D. Anderson Cancer Center · NCT05049746
This study is trying to understand what older women with breast cancer need to know to make decisions about chemotherapy, so they can create a helpful tool for patients and doctors.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05049746 on ClinicalTrials.gov |
What this trial studies
This study aims to identify the decision-making needs of older adult women with stage I-III breast cancer who are considering neoadjuvant or adjuvant chemotherapy. It involves conducting semi-structured interviews and utilizing validated instruments to assess their informational needs and preferences. Based on this information, a decision support tool will be developed to assist patients and healthcare providers in navigating the chemotherapy decision-making process. The tool will undergo cognitive testing and field testing to ensure its feasibility and acceptability in real-world clinical settings.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 65 years or older who have been diagnosed with stage I-III breast cancer and are considering chemotherapy.
Not a fit: Patients who do not speak or write English or those who are not making a decision regarding chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could empower older women with breast cancer to make informed decisions about their chemotherapy options.
How similar studies have performed: Other studies have shown success in developing decision support tools for cancer treatment, indicating that this approach has potential.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Meghan Karuturi — M.D. Anderson Cancer Center
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anatomic Stage I Breast Cancer AJCC V8, Anatomic Stage IA Breast Cancer AJCC V8, Anatomic Stage IB Breast Cancer AJCC V8, Anatomic Stage II Breast Cancer AJCC V8, Anatomic Stage IIA Breast Cancer AJCC V8, Anatomic Stage IIB Breast Cancer AJCC V8, Anatomic Stage III Breast Cancer AJCC V8, Anatomic Stage IIIA Breast Cancer AJCC V8