Culturally Aware AET Non-Initiation Intervention

Completed · Not applicable

Conditions studied: Breast Cancer, Survivorship, Treatment Compliance, Treatment Adherence, Treatment Refusal

In brief

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.

Key facts

Study ID

NCT05465408

Run by

Massachusetts General Hospital

People needed

35

Starts

2022-07-21

Expected to finish

2024-11-20

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute at St Elizabeth's Medical Center — Brighton, Massachusetts, United States
• Emerson Hospital/MGH Cancer Center — Concord, Massachusetts, United States
• Mass General at North Shore Cancer Center — Danvers, Massachusetts, United States
• Dana-Farber Brigham Cancer Center - Foxborough — Foxborough, Massachusetts, United States
• Dana-Farber Cancer Institute - Merrimack Valley — Methuen, Massachusetts, United States
• Dana-Farber Brigham Cancer Center at Milford Regional Medical Center — Milford, Massachusetts, United States
• Mass General at Newton Wellesley Hospital — Newton, Massachusetts, United States
• Dana-Farber Brigham Cancer Center with South Shore Hospital — Weymouth, Massachusetts, United States
• Dana-Farber/New Hampshire Onoclogy-Hematology — Londonderry, New Hampshire, United States

Full record on ClinicalTrials.gov

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