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NCT Number: NCT05049746

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Discussion

Other

Participate in discussion

Other names: Discuss

interview

Other

Participate in interview

Questionnaire Administration

Other

Complete questionnaire

Primary outcomes

  1. Decision making needs assessment questionnaire

    Time frame: 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

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2027
Study completion
2027
First posted
Sep 20, 2021
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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