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

Not Applicable

Recruiting

• 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
• Interventions: Other: Discussion; Other: Interview; Other: Questionnaire Administration

• Registration Number: NCT05049746
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-08-23
• Study First Submitted: 2021-08-02
• Study First Submitted QC: 2021-09-16
• Study First Posted: 2021-09-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-02
• Last Update Posted: 2024-10-04
• Primary Completion: 2025-08-23
• Study Completion: 2025-08-23

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

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Exclusion Criteria

None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Questionnaire Administration	Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process
Intervention Arm	Discussion	Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process
Intervention Arm	Interview	Participants in the intervention arm only will then be asked to look at the decision tool that includes educational materials about the diagnosis and treatment of breast cancer. These could be written information, graphics, videos, animations, or questionnaires. This decision tool will personalize the decision to you specifically and support your decision-making process

Primary Outcome Measures

Name	Time	Method
Decision making needs assessment questionnaire	through study completion, an average of 1 year	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

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States