Culturally Aware AET Non-Initiation Intervention (NCT05465408) | Clinical Trial Compass
CompletedNot Applicable
Culturally Aware AET Non-Initiation Intervention
United States35 participantsStarted 2022-07-21
Plain-language summary
The purpose of this study is to examine the feasibility and acceptability of a brief, nurse-led intervention to support breast cancer survivors who have delayed initiation of hormonal therapy or who have concerns about starting hormonal therapy.
Who can participate
Age range
18 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:
* Female
* Age 21 or older
* Diagnosis of early-stage (Stage I-IIIB), hormone receptor-positive breast cancer
* Recommended to start AET at least 3 weeks prior and not currently taking AET OR recommended to start AET in the future, and reports hesitations to start AET as determined by a score of \>/= 4 (range =0-10) when asked "How hesitant are you about starting your recommended hormonal therapy? (0=Not at all hesitant and 10 = Extremely hesitant)"
* Ability to read and respond in English or Spanish
* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
* For at least 10 participants, identify as a member of a racial or ethnic minority community per self-report
Exclusion Criteria:
* Uncontrolled psychosis, active suicidal ideation, psychiatric hospitalization within the past year
* Cognitive impairment that prohibits participation in the study
* Undergoing primary treatment for another cancer (i.e., advanced-stage cancer)
* Participating in a clinical trial involving AET
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.