Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
NCT ID: NCT05049746
Last Updated: 2025-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
95 participants
INTERVENTIONAL
2016-02-23
2027-02-02
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention Arm
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
Discussion
Participate in discussion
Interview
Participate in interview
Questionnaire Administration
Complete questionnaire
Non-Intervention Arm
Participants 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.
No interventions assigned to this group
Interventions
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Discussion
Participate in discussion
Interview
Participate in interview
Questionnaire Administration
Complete questionnaire
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 for patient recruited to participate in study (physician criteria)
Exclusion Criteria
65 Years
FEMALE
Yes
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Meghan Karuturi
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-07005
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-0055
Identifier Type: OTHER
Identifier Source: secondary_id
2016-0055
Identifier Type: -
Identifier Source: org_study_id
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