Breast Cancer Clinical Trial
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Summary
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.
Full Description
PRIMARY OBJECTIVES:
I. To characterize and describe the informational needs and preferences in older adult women who intend on receiving neoadjuvant or adjuvant chemotherapy for stage I-III breast cancer.
Ia. Conduct semi-structured interviews with women who have completed the treatment decision process to collect informational needs and elicit decision-making needs and preferences.
Ib. Utilize validated data collection instruments to assess the shared decision-making process and health literacy needs.
II. To develop a decision support tool for use by patients and healthcare providers to guide the chemotherapy decision-making process in older women (>= 65) with early-stage breast cancer.
IIa. To conduct cognitive testing of the decision tool. IIb. To conduct a field test of the decision tool in order to demonstrate feasibility and acceptability in real-world clinical settings.
OUTLINE:
Patients 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. Subsequently, a decision support tool will be developed consistent with standards for content development and evaluation from the International Patient Decision Aid Standards (IPDAS) Collaboration and implemented through an iterative process of design, development and evaluation to engage end users in its development. Once developed, field testing of the decision tool will be conducted to demonstrate feasibility and acceptability in real-world clinical setting, followed by pilot testing to evaluate the efficacy of the decision support tool.
Eligibility 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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
Houston Texas, 77030, United States More Info
Principal Investigator
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.