Trials / Active Not Recruiting

Active Not RecruitingNCT05049746

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

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

Status: Active Not Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 95 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: Female
Age: 65 Years
Healthy volunteers: Accepted

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.

Conditions

Interventions

Type	Name	Description
OTHER	Discussion	Participate in discussion
OTHER	Interview	Participate in interview
OTHER	Questionnaire Administration	Complete questionnaire

Timeline

Start date: 2016-02-23
Primary completion: 2027-02-02
Completion: 2027-02-02
First posted: 2021-09-20
Last updated: 2025-09-23

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05049746. Inclusion in this directory is not an endorsement.