Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
2 other identifiers
interventional
95
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 23, 2016
CompletedFirst Submitted
Initial submission to the registry
August 2, 2021
CompletedFirst Posted
Study publicly available on registry
September 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 2, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 2, 2027
May 1, 2026
April 1, 2026
11 years
August 2, 2021
April 27, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Decision making needs assessment questionnaire
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
through study completion, an average of 1 year
Study Arms (2)
Intervention Arm
OTHERParticipants 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
Non-Intervention Arm
NO INTERVENTIONParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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 for patient recruited to participate in study (physician criteria)
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meghan Karuturi
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2021
First Posted
September 20, 2021
Study Start
February 23, 2016
Primary Completion (Estimated)
February 2, 2027
Study Completion (Estimated)
February 2, 2027
Last Updated
May 1, 2026
Record last verified: 2026-04