Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considerin… (NCT05049746) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Identifying Decision Making Needs for Older Adult Women With Stage I-III Breast Cancer Considering Neoadjuvant or Adjuvant Chemotherapy
United States95 participantsStarted 2016-02-23
Plain-language 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.
Who can participate
Age range
65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Decision making needs assessment questionnaire
Timeframe: through study completion, an average of 1 year