Clinical trial NCT05049746: Identifying Decision Making Needs for Older Adult Women with Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Official title: Identifying Decision Making Needs for Older Adult Women with Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Anatomic Stage IIIB Breast Cancer AJCC V8
Anatomic Stage IIIC Breast Cancer AJCC V8
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Primary outcomes:
measure: Decision making needs assessment questionnaire
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Meghan Karuturi
role: PRINCIPAL_INVESTIGATOR
References: