Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:

Identifying Decision Making Needs for Older Adult Women With Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05049746
• Other study ID #: 2016-0055
• Secondary ID: NCI-2021-0700520
• Status: Recruiting
• Phase: N/A
• Start date: August 23, 2016
• Est. completion date: August 23, 2025

Study information

• Verified date: February 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 23, 2025
• Est. primary completion date: August 23, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• 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
• Anatomic Stage IIIB Breast Cancer AJCC v8
• Anatomic Stage IIIC Breast Cancer AJCC v8
• Breast Neoplasms
• Prognostic Stage I Breast Cancer AJCC v8
• Prognostic Stage IA Breast Cancer AJCC v8
• Prognostic Stage IB Breast Cancer AJCC v8
• Prognostic Stage II Breast Cancer AJCC v8
• Prognostic Stage IIA Breast Cancer AJCC v8
• Prognostic Stage IIB Breast Cancer AJCC v8
• Prognostic Stage III Breast Cancer AJCC v8
• Prognostic Stage IIIA Breast Cancer AJCC v8
• Prognostic Stage IIIB Breast Cancer AJCC v8
• Prognostic Stage IIIC Breast Cancer AJCC v8

Intervention

Other:
• Discussion
Participate in discussion
• Interview
Participate in interview
• Questionnaire Administration
Complete questionnaire

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decision making needs assessment questionnaire	The mean score of the shared decision making questionnaire and its standard deviation along with the median and the range will be computed for both the patient and physician study population. Score Range-(0-4) 0-Not at all confident 4-very confident	through study completion, an average of 1 year

External Links

•   M D Anderson Cancer Center